Pharma Manual.pdf

24
Index of all Pharmaceutical Guidelines. Click on Guideline to Open. www.pharmaguideline.com Pharmaceutical Guidelines: Guidelines for Quality Assurance 30 common ways to avoid making the most frequent GMP errors Adverse reaction of pharmaceutical dosages forms An overview of ISO 14644 clean room classification Analytical method validation Biocontamination control techniques for purified water sysem Chemical Sanitization of RO Systems and Biofilm Removal Clean Room System in Sterile Pharmaceutical Clean Rooms And Controlled Areas (Sterile Area Classification) Cleaning Validation Protocol for Pharmaceuticals Cleaning Validation in Pharmaceuticals Cleaning Validation of Pharmaceutical Equipments Cleaning and Disinfection of a Newly Purified water system before Start Up Clinical Trials Concept of Revalidation in Pharmaceuticals Corrective and Preventive actions (CAPA) Deviation Control in Pharmaceuticals Differece between water (moisture) content and loss on drying (LOD) Difference among calibration, validation & qualification FDA´s New Process Validation Guidance Facility Qualification in Pharmaceuticals GMP Audit Check List- Equipment GMP Audit Check List- Filling and Packaging GMP Audit Check List- Personnel and Premises GMP Audit Check List- Process Validation GMP Audit Check List- Sanitation and Hygiene GMP Audit Check List- Storage of Starting Materials GMP Audit Check List- Weighing and Dispensing GMP Audit Check List- water supply system GMP Observations in Production Good Documentation Practices (GDP) in Pharmaceuticals Guide To Inspections of High Purity Water Systems Guidelines for preparation of Site Master File (SMF) Guidelines for the preparation of VMP (Validation Master Plan) HEPA filters used in pharmaceuticals HVAC system validation tests Handling of Pharmaceutical Market Complaints Handling of out of calibration instruments and equipment High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations Hold time study of cleaned equipments List of Standard Operating Procedures (SOPs) in Quality Assurance Media Fill Validation -SVP Media fill validation test in sterile pharmaceutical Mix Up and Cross Contamination in Pharmaceutical Manuacturing Non-sterile Process Validation in Pharmaceuticals

description

Document covers several links to useful SOPs and quality manuals

Transcript of Pharma Manual.pdf

Page 1: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Pharmaceutical Guidelines:

Guidelines for Quality Assurance

30 common ways to avoid making the most frequent GMP errors

Adverse reaction of pharmaceutical dosages forms

An overview of ISO 14644 clean room classification

Analytical method validation

Biocontamination control techniques for purified water sysem

Chemical Sanitization of RO Systems and Biofilm Removal

Clean Room System in Sterile Pharmaceutical

Clean Rooms And Controlled Areas (Sterile Area Classification)

Cleaning Validation Protocol for Pharmaceuticals

Cleaning Validation in Pharmaceuticals

Cleaning Validation of Pharmaceutical Equipments

Cleaning and Disinfection of a Newly Purified water system before Start Up

Clinical Trials

Concept of Revalidation in Pharmaceuticals

Corrective and Preventive actions (CAPA)

Deviation Control in Pharmaceuticals

Differece between water (moisture) content and loss on drying (LOD)

Difference among calibration, validation & qualification

FDA´s New Process Validation Guidance

Facility Qualification in Pharmaceuticals

GMP Audit Check List- Equipment

GMP Audit Check List- Filling and Packaging

GMP Audit Check List- Personnel and Premises

GMP Audit Check List- Process Validation

GMP Audit Check List- Sanitation and Hygiene

GMP Audit Check List- Storage of Starting Materials

GMP Audit Check List- Weighing and Dispensing

GMP Audit Check List- water supply system

GMP Observations in Production

Good Documentation Practices (GDP) in Pharmaceuticals

Guide To Inspections of High Purity Water Systems

Guidelines for preparation of Site Master File (SMF)

Guidelines for the preparation of VMP (Validation Master Plan)

HEPA filters used in pharmaceuticals

HVAC system validation tests

Handling of Pharmaceutical Market Complaints

Handling of out of calibration instruments and equipment

High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations

Hold time study of cleaned equipments

List of Standard Operating Procedures (SOPs) in Quality Assurance

Media Fill Validation -SVP

Media fill validation test in sterile pharmaceutical

Mix Up and Cross Contamination in Pharmaceutical Manuacturing

Non-sterile Process Validation in Pharmaceuticals

Page 2: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Passivation of Purified water system/ WFI system in pharmaceuticals

Pharmaceutical Bioavailability and Bioequivalence

Pharmaceutical product recall procedure

Prevention of Cross - contamination during Processing

Prevention of Cross- contamination by HVAC in Pharmaceuticals

Prevention of Cross- contamination in Pharmaceuticals

Procedure for Change Control in Pharmaceuticals

Procedure for garment change and entry and exit through first and primary change room

Procedure for in process checking during off-line and on line packing in pharmaceuticals

Procedure for line clearance before commencing any manufacturing operation

Procedure for preparation of APR (Annual Product Review)

Procedure for the qualification of vendors for the raw material and packaging materials

Product Recall Procedure in Pharmaceuticals

Prospective Validation

Protocol for hold time study of prepared control standard endotoxin (CSE)

Purified Water System

Purified Water System Validation

Purpose of Process Validation in Pharmaceuticals

Qualification of systems and equipments in pharmaceuticals

Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical

Rounding Off Values In GMP Documents in Pharmaceuticals

Rounding off figures of analytical results

SOP of SOP (SOP on SOP) in Pharmaceuticals

SOP on Standard Operating Procedure

Site Master File (SMF) for pharmaceuticals

Summary of ISO 14644 (ISO cleanliness classes)

Terminology & Definitions in Pharmaceuticals

Types of water used in pharmaceutical processes

Validation in pharmaceutical manufacturing

Validation of Supporting Processes in Pharmaceuticals

WHO Qualification List for Pharmaceutical Equipments

WHO SOP list for Pharma Microbiology

WHO SOP list for Pharma Production

WHO SOP list for Pharma Quality Assurance

WHO SOP list for Pharma Quality Control

WHO SOP list for Pharma Quality Control Cleaning

WHO SOP list for Pharma Quality Control Operations

WHO: Water for pharmaceutical use

What WHO says about cross-contamination?

What is HEPA filter? Its use in Pharma

What is change control ?

cGMP guidelines for pharmaceutical industries part-1

cGMP guidelines for pharmaceutical industries part-2

cGMP regulations for finished pharmaceuticals and medical devices

Page 3: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Guidelines for Quality Control

Analytical Balance Calibration

Analytical method validation

Appearance of Solution

Assay of Ascorbic acid

Assay of Calcium Carbonate

Assay of Calcium Citrate

Atomic Absorption Spectrometry

Atomic Emission Spectrometry

Bursting Strength Tester

Calibration of Brookfield viscometer in pharmaceuticals

Calibration of Disintegration Test Apparatus

Calibration of FT-IR Spectrophotometer

Calibration of Halogen moisture analyzer

Calibration of TOC (Total Organic Carbon)Analyser

Calibration of Total organic carbon Analyzer

Calibration of UV / Visible spectrophotometer

Calibration of Volumetric Glassware used in Pharmaceuticals

Calibration of automatic potentiometric titrator

Calibration of digital polarimeter

Calibration of eppendorf centrifuge apparatus

Calibration of glassware (class A and class B)

Calibration of hardness tester in pharmaceuticals

Calibration of melting point apparatus

Calibration of refractometer in pharmaceuticals

Calibration of vernier caliper

Cleaning of Glassware With Nitric Acid and Chromic Acid

Climatic zones for stability studies

Conductivity of Purified Water (Apparatus and Procedure) in Pharmaceutical

Congealing Range or Temperature

Contents (Weight or Volume Uniformity) of Packaged Dosage Forms

Determination and Acceptance limits of Uniformity of Content of Single-Dose Preparations

Determination of Acetyl Value

Determination of Acid Value

Determination of Assay of Nitrous Oxide

Determination of Assay of Oxygen

Determination of Assay of Steroids

Determination of Assay of Vitamin D

Determination of Boiling Range or Temperature and Distillation Range

Determination of Esters

Determination of Ethanol-Soluble Extractive

Determination of Foreign Organic Matter

Determination of Freezing Point

Determination of Hydroxyl Value

Determination of Iodine Value

Determination of Loss on Ignition

Determination of Methoxyl

Page 4: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Determination of Nitrogen

Determination of Optical Rotation and Specific Optical Rotation

Determination of Peroxide Value

Determination of Refractive Index

Determination of Saponification Value

Determination of Solubility in Pharmaceuticals

Determination of Sulphur Dioxide

Determination of Total Organic Carbon in Purified Water

Determination of Total Solids

Determination of Unsaponifiable Matter

Determination of Viscosity by Using Ostwald-type, Suspended-level and Rotating Viscometer

Determination of Weight Per Millilitre and Relative Density

Determination of Zinc Content

Differece between water (moisture) content and loss on drying (LOD)

Difference among calibration, validation & qualification

Dimensions of Hard Gelatin Capsule Shells

Disintegration Test and Apparatus

Dissolution Test (DT) Apparatus Operating Procedure

Dissolution Test and Apparatus

Dissolution Testing apparatus calibration in pharmaceuticals

Flame Photometry (Apparatus and Method)

Fluorimetry

Friability Test Apparatus Calibration

Friability of Uncoated Tablets

GC Calibration

Good Documentation Practices (GDP) in Pharmaceuticals

Good Laboratories Practice (GLP) in Pharmaceuticals

Guideline for preparation of mobile phase required for HPLC

Guidelines For Receipt And Usage of Reference Standards and Qualification and Usage of

Working Standards

Guidelines for Pharmaceutical Stability Study

HPLC Caibration in Pharmaceuticals

HPLC Column Performance Evaluation and Column Care

Handling of out of calibration instruments and equipment

Handling, Cleaning & Storage of Cuvettes of Spectrophotometer

Havey Metals Testing

ICH Guidelines for Pharmaceuticals

Identification Test of Barbiturates

Identification of Environmental Flora

Identification test of Phenothiazines

Indicator (Litmus Paper) and Test Papers

Investigation on sterility failure

Ionising Radiation Sterilisation

Karl fisher apparatus calibration in pharmaceuticals

Limit Test for Aluminium

Limit Test for Arsenic in Pharmaceuticals

Limit Test for Heavy Metals in Pharmaceuticals

Limit Test for Iron and Lead

Page 5: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Limit Test for Potassium and Sulphates

List of Current ICH Quality Guidelines for Stability

List of Standard Operating Procedures (SOPs) in Quality Control (QC)

Maintenance of Primary Standards in Pharmaceutical Industries

Melting Range or Temperature (Apparatus and Deternination)

Method for Nitrite Titration

Operating Procedure for Weighing Balances

Paper Chromatography (Apparatus and Peocedure)

Particle Size by Microscopy

Pharmaceutical Analytical Method Validation With Definitions

Pharmaceutical Bioavailability and Bioequivalence

Pharmaceuticals Limit tests

Potentiometric Titration

Powder Fineness (Types of Powder)

Preparation and Standardisation of Volumetric Solutions

Preparation and Standardization of 0.004 M Benzethonium Chloride

Preparation and Standardization of 0.1 M Ceric Ammonium Nitrate

Preparation and Standardization of 0.0005 M Dioctyl Sodium Sulphosuccinate

Preparation and Standardization of 0.001 M Sodium Dodecyl Sulphate

Preparation and Standardization of 0.0167 M Potassium Dichromate

Preparation and Standardization of 0.02 M Cupric Sulphate

Preparation and Standardization of 0.02 M Mercuric Nitrate

Preparation and Standardization of 0.02 M Potassium Permanganate

Preparation and Standardization of 0.05 M Magnesium Sulphate

Preparation and Standardization of 0.05 M Barium Chloride

Preparation and Standardization of 0.05 M Bromine

Preparation and Standardization of 0.05 M Iodine

Preparation and Standardization of 0.05 M Potassium Iodate

Preparation and Standardization of 0.1 M Ammonium Thiocyanate

Preparation and Standardization of 0.1 M Ceric Ammonium Sulphate

Preparation and Standardization of 0.1 M Disodium Edetate (EDTA)

Preparation and Standardization of 0.1 M Ethanolic Potassium Hydroxide

Preparation and Standardization of 0.1 M Ethanolic Sodium Hydroxide

Preparation and Standardization of 0.1 M Ferric Ammonium Sulphate

Preparation and Standardization of 0.1 M Ferrous Ammonium Sulphate

Preparation and Standardization of 0.1 M Hydrochloric acid (HCl)

Preparation and Standardization of 0.1 M Lead Nitrate

Preparation and Standardization of 0.1 M Lithium Methoxide

Preparation and Standardization of 0.1 M Perchloric acid

Preparation and Standardization of 0.1 M Potassium Hydroxide

Preparation and Standardization of 0.1 M Silver nitrate

Preparation and Standardization of 0.1 M Sodium Methoxide

Preparation and Standardization of 0.1 M Sodium Nitrite

Preparation and Standardization of 0.1 M Sodium Thiosulphate

Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide

Preparation and Standardization of 0.1 M Titanium Trichloride

Preparation and Standardization of 0.1 M Zinc Chloride

Preparation and Standardization of 0.1 M Zinc Sulphate

Page 6: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Preparation and Standardization of 0.25 M Ethanolic Sulphuric Acid

Preparation and Standardization of 0.5 M Methanolic Hydrochloric Acid

Preparation and Standardization of 0.5 M Potassium Hydroxide in ethanol (60 per cent )

Preparation and Standardization of 0.5 M Sulphuric Acid

Preparation and Standardization of 1 M Nitric Acid

Preparation and Standardization of 1M Hydrochloric Acid

Preparation and Standardization of Volumeteric Solutions

Preparation of Buffer Solutions

Preparation of Indicator Solutions

Preparation of Standard Solutions

Primary Standards used in Pharmaceuticals

Principle and Calibration of Ultraviolet and Visible Absorption Spectrophotometry

Procedure for the qualification of vendors for the raw material and packaging materials

Purified Water Specification as per IP/BP/USP

Purified Water System

Purified Water System Validation

Purified Water Testing (Method of analysis) as per IP/BP/USP

Purified water testing in Pharmaceuticals

Raw Water Testing (Method of Analysis) as per IP/BP/USP

Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical

Resolution factor, Telling factor, Theoretical Plates and Capacity factor in HPLC

Retesting of raw materials

Rounding Off Values In GMP Documents in Pharmaceuticals

Rounding off figures of analytical results

Sampling procedure for purified water

Sampling, preservation and storage procedure of water sample

Size-Exclusion Chromatography

Specification for water for injection (WFI) as per USP

Tapped Density Tester

Terminology & Definitions in Pharmaceuticals

Test for Free Formaldehyde (Formaldehyde Content)

Test for Sulphated Ash and Total Ash

Testing procedure (Method of analysis) for Acetates,Acetyl Groups and Alkaloids

Testing procedure (Method of analysis) for Aluminium Salts, Amines and Ammonium salts

Testing procedure (Method of analysis) for Antimony, Arsenic and Barium Salts

Testing procedure (Method of analysis) for Benzoates, Bicarbonates and Bismuth Compounds

Testing procedure (Method of analysis) for Bromides, Calcium Salts and Carbonates

Testing procedure (Method of analysis) for Chlorides, Citrates and Esters

Testing procedure (Method of analysis) for Ferric salts, Ferrous Salts and Iodides

Testing procedure (Method of analysis) for Lactates, Lead Compounds and Magnesium Salts

Testing procedure (Method of analysis) for Mercury Compounds, Nitrates and Phosphates

(Orthophosphates)

Testing procedure (Method of analysis) for Potassium Salts, Salicylates and Silicates

Testing procedure (Method of analysis) for Silver Compounds, Sodium Salts and Sulphates

Testing procedure (Method of analysis) for Sulphur in Organic Compounds, Tartrates and

Thiosulphates

Testing procedure (Method of analysis) for Xanthines and Zinc Salts

Thin-Layer Chromatography (TLC Method and Apparatus)

Page 7: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Types of water used in pharmaceutical processes

UV Cabinet Calibration in Pharmaceuticals

UV Light Efficiency Test

Ultrasonic bath

Ultraviolet and Visible Absorption Spectrophotometer (Apparatus and Calibration)

Uniformity of Weight of Single-Dose Preparations

Update on Schedule L1

Vacuum pump

Validation of excel calculation sheets

Viscometer calibration

WHO SOP list for Pharma Quality Control

WHO SOP list for Pharma Quality Control Cleaning

WHO SOP list for Pharma Quality Control Operations

Water Content Determination by Karl Fischer

What is Loss on Drying ? and Determination of Loss on Drying

cGMP guidelines for pharmaceutical industries part-1

cGMP guidelines for pharmaceutical industries part-2

pH Values (Apparatus and Method of Determination)

Guidelines for Microbiology

An overview of ISO 14644 clean room classification

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Assay of Biotin or Vitamin B7 (Biological method) in Pharmaceuticals

Assay of Folic Acid or Vitamin B9 (by microbiological method)

Autoclave Validation in Pharmaceuticals

BET: Bacterial Endotoxin (LAL)Test.

Bacterial Endotoxin Test (BET or LAL Test) Validation

Bacterial Endotoxin Test Methods

Biocontamination control techniques for purified water sysem

Biological Indicator for Dry Heat Sterilization Processes

Biological Indicator for Moist Heat (Steam) Sterilization Processes

Calibration of Heating block

Calibration of Micropipettes

Calibration of Microscope

Chemical Sanitization of RO Systems and Biofilm Removal

Clean Room System in Sterile Pharmaceutical

Clean Rooms And Controlled Areas (Sterile Area Classification)

Cleaning and Disinfection of a Newly Purified water system before Start Up

Culture Media

D value, Z value and F0 value calculations

Destruction of microbial waste

Difference among calibration, validation & qualification

Disinfectant Efficacy Test

Effectiveness of Antimicrobial Preservatives in Pharmaceutical Drugs

Endotoxin Detection by End-Point Chromogenic Method

Endotoxin Detection by Gel-Clot Limit Test Method

Endotoxin Detection by Gel-Clot Methods

Page 8: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Endotoxin Detection by Kinetic Thrbidimetric and Kinetic Chromogenic Methods

Endotoxin Detection by Quantitative Methods

Endotoxin Detection by Semi-Quantitative Gel-Clot Method

GMP Audit Check List- Equipment

GMP Audit Check List- Filling and Packaging

GMP Audit Check List- Personnel and Premises

GMP Audit Check List- Process Validation

GMP Audit Check List- Sanitation and Hygiene

GMP Audit Check List- Storage of Starting Materials

GMP Audit Check List- Weighing and Dispensing

GMP Audit Check List- water supply system

GMP Observations in Production

Good Documentation Practices (GDP) in Pharmaceuticals

Good Laboratories Practice (GLP) in Pharmaceuticals

Growth Promotion Test

Guide To Inspections of High Purity Water Systems

HEPA filters used in pharmaceuticals

HVAC system validation tests

High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations

How Sterilization is done by Filtration?

Identification of Environmental Flora

Investigation on sterility failure

Ionising Radiation Sterilisation

MLT (Microbial Limit Test) Validation

MLT: Microbial Limit Test

Maintenance of Microbial cultures

Media Fill Validation -SVP

Media fill validation test in sterile pharmaceutical

Microbiological Assay of Cyanocobalamin or Vitamin B12

Mix Up and Cross Contamination in Pharmaceutical Manuacturing

Passivation of Purified water system/ WFI system in pharmaceuticals

Performance Evaluation of Biological Indicators

Performance Qualification Protocol for Sterilization and Depyrogenating Tunnel

Performance Qualification of Autoclave cum Bung Processor

Performance Qualification of High Pressure High Vaccum (HPHV) Steam Sterilizer in

Pharmaceuticals

Personnel monitoring of sterile area

Preservative Efficacy Test

Prevention of Cross - contamination during Processing

Prevention of Cross- contamination by HVAC in Pharmaceuticals

Prevention of Cross- contamination in Pharmaceuticals

Procedure for air sampling (environmental monitoring) in sterile pharmaceutical manufacturing

area

Procedure for garment change and entry and exit through first and primary change room

Protocol for hold time study of prepared control standard endotoxin (CSE)

Purified Water System

Purified Water System Validation

Pyrogens Testing in Pharmaceuticals

Page 9: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Qualification of systems and equipments in pharmaceuticals

Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical

SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V

Sampling procedure for purified water

Sampling, preservation and storage procedure of water sample

Steam sterilisation (Heating in an autoclave)

Sterility testing procedure

Sterlity Validation (Membrane Filtration) in Pharmaceuticals

Types of Biological Indicators

Types of water used in pharmaceutical processes

Update on Schedule L1

Validation in pharmaceutical manufacturing

Validation of Dry Heat Sterilizer (DHS)

Validation of Supporting Processes in Pharmaceuticals

Validation of shelf life for 70% v/v isopropyl alcohol (IPA)

WHO SOP list for Pharma Microbiology

WHO: Water for pharmaceutical use

What WHO says about cross-contamination?

What is HEPA filter? Its use in Pharma

cGMP guidelines for pharmaceutical industries part-1

cGMP guidelines for pharmaceutical industries part-2

cGMP regulations for finished pharmaceuticals and medical devices

Guidelines for Production

30 common ways to avoid making the most frequent GMP errors

Biocontamination control techniques for purified water sysem

Chemical Sanitization of RO Systems and Biofilm Removal

Clean Room System in Sterile Pharmaceutical

Clean Rooms And Controlled Areas (Sterile Area Classification)

Cleaning Validation Protocol for Pharmaceuticals

Cleaning Validation in Pharmaceuticals

Cleaning Validation of Pharmaceutical Equipments

Cleaning and Disinfection of a Newly Purified water system before Start Up

Concept of Revalidation in Pharmaceuticals

Difference among calibration, validation & qualification

Dry granulation process

Film coating process in pharmaceuticals

Film coating process of tablets in pharma manufacturing

GMP Audit Check List- Equipment

GMP Audit Check List- Filling and Packaging

GMP Audit Check List- Personnel and Premises

GMP Audit Check List- Process Validation

GMP Audit Check List- Sanitation and Hygiene

GMP Audit Check List- Storage of Starting Materials

GMP Audit Check List- Weighing and Dispensing

GMP Audit Check List- water supply system

GMP Observations in Production

Page 10: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Good Documentation Practices (GDP) in Pharmaceuticals

Granulation and particle-bonding mechanism of granulation

Guideline for pharmaceutical packing operation

High-Efficiency Particulate Air (HEPA) and its significance in sterile pharmaceutical preparations

Hold time study of cleaned equipments

List of Standard Operating Procedures (SOPs) in Production

Media Fill Validation -SVP

Media fill validation test in sterile pharmaceutical

Mix Up and Cross Contamination in Pharmaceutical Manuacturing

Non-sterile Process Validation in Pharmaceuticals

Operating Procedure for Weighing Balances

Operation and Cleaning of Machanical Sifter

Operation and Cleaning of Octagonal Blender

Operation and Cleaning of Roll Compector

Operation and Cleaning of Tablet Deduster Machine

Operation and Cleaning of Tablet Inspection Machine

Operation and Cleaning of Tray Dryer

Passivation of Purified water system/ WFI system in pharmaceuticals

Pharmaceutical Analytical Method Validation With Definitions

Prevention of Cross - contamination during Processing

Prevention of Cross- contamination by HVAC in Pharmaceuticals

Prevention of Cross- contamination in Pharmaceuticals

Procedure for Operation and Cleaning of Metal Detector

Procedure for Operation and Cleaning of Rapid Mix Granulator (RMG)

Procedure for garment change and entry and exit through first and primary change room

Procedure for in process checking during off-line and on line packing in pharmaceuticals

Procedure for line clearance before commencing any manufacturing operation

Purified Water System

Purified Water System Validation

Purpose of Process Validation in Pharmaceuticals

Sugar coating process and its problems in pharmaceuticals

Tablet coating problems and their solutions in pharmaceuticals

Terminology & Definitions in Pharmaceuticals

Tooling of Oral Solid Dosage Form (Tablet)

Types of water used in pharmaceutical processes

Validation in pharmaceutical manufacturing

Validation of Supporting Processes in Pharmaceuticals

WHO Qualification List for Pharmaceutical Equipments

WHO SOP list for Pharma Production

Wet Granulation Process

What WHO says about cross-contamination?

cGMP guidelines for pharmaceutical industries part-1

cGMP guidelines for pharmaceutical industries part-2

cGMP regulations for finished pharmaceuticals and medical devices

Page 11: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

Standard Operating Procedures (SOPs) for Pharmaceuticals

SOP For Operation And Calibratioin of Polarimeter

SOP For Analysis And Release of Finished Sample

SOP For Backup/Restore And Archival of Analytical Data,In Electronic Form

SOP For Calibration Of Colony Counter

SOP For Calibration Of Glasswares

SOP For Calibration Of Hot Air Oven

SOP For Calibration Procedure of BOD / Bacteriological Incubator

SOP For Calibration of UV-Vis Spectrophotometer

SOP For Cleaning And Operation of Horizontal Autoclave

SOP For Cleaning And Operation of Verticle Autoclave

SOP For Cleaning Of Quality Control Laboratory

SOP For Cleaning Of Refrigerator

SOP For Cleaning Of Sampling Equipment

SOP For Cleaning and sterilization of glassware used in microbiology lab .

SOP For Cleaning of microbiology lab

SOP For Control of Record of Analysis

SOP For Entry/Exit Procedure For Quality Control Laboratory

SOP For Good Laboratory Practice

SOP For HPLC Analysis And Documentation

SOP For Handling Of Glassware

SOP For Identification Of Micorganisms

SOP For Laminar Flow Workbench

SOP For Maintenance Of Desiccator

SOP For Media Preparation And Growth Promotion Test

SOP For Monitoring Of Raw And Potable Water Quality

SOP For Operating Procedure For Air Sampler

SOP For Operation And Calibration Of FT-IR Spectrometer

SOP For Operation And Calibration Of Hot Air Oven

SOP For Operation And Calibration Of Leak Test Apparatus

SOP For Operation And Calibration Of Refractometer

SOP For Operation And Calibration Of Tap Density Apparatus

SOP For Operation And Calibration Of Vernier Caliper

SOP For Operation And Calibration Of Water Bath

SOP For Operation And Calibration Of pH Meter (Pico+)

SOP For Operation And Calibration of Auto Titrator (Metrohm)

SOP For Operation And Calibration of Microscope

SOP For Operation And Calibration of Sieve Shaker

SOP For Operation Of C/75 % RH) Control Envronment Chamber (40

SOP For Operation Of Milli- Q Water System

SOP For Operation Of Muffle Furnace

SOP For Operation Of UV Cabinet

SOP For Operation and Calibration of Melting Point Apparatus

SOP For Operation of Bacteriological Incubator

Page 12: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP For Operation of C/75 % RH) Control Envronment Chamber (30

SOP For Operation of HPLC System Using Chemistation Software

SOP For Operation of UV- Visible Spectrophotometer

SOP For Preparation And Standardisation Of Volumetric Solution

SOP For Preparation Of Standard, General Reagent And Indicator Solution

SOP For Preparation of Culture Of Microorganism

SOP For Preventive Maintenance Of Instrument

SOP For Procedure For Glasswares Washing

SOP For Procedure For Opening of Lyopholized Vial of Microorganism

SOP For Qualification of Facility/Equipments/Systems

SOP For Recrding of Analytical Data In Raw Data Sheet

SOP For Safety Measurs of QC Laboratory

SOP For Sampling Of Raw Material

SOP For Storage Of Sampling Tool

SOP For The Enumeration of Spore Count In Biological Indicators

SOP For Validation Of Autoclave With Biological Indicator For Sterilization Efficiency

SOP For Washing Of HPLC Column

SOP For handling of market complaints

SOP for Antimicrobial effectiveness testing

SOP for Bacterial Endotoxin Test

SOP for Clean Inspection of media fill vials and qualification of inspectors

SOP for Cleaning and Operation of Anaerobic Culture Jar

SOP for Cleaning and sanitization of Microbiology lab

SOP for Cleaning of Glassware

SOP for Cleaning of Glassware for Microbiological testing

SOP for Collection and Testing of samples during Process Simulation

SOP for Deaeration of Dissolution media

SOP for Dispensing and Issuance of Raw Material

SOP for Disposable of mediafill vials after incubation

SOP for Disposal of Contaminated Material

SOP for Disposal of media fill vials

SOP for Entry and Exit procedure for microbiology testing area and Sterility testing area

SOP for Entry and exit in Microbiology testing area

SOP for Handling and Storage of Raw & Packing Material

SOP for Handling of Market Complaints in Pharmaceuticals

SOP for Identification of microbial cultures using biomeriux identification system

SOP for Investigation on sterility failure, which is required to find out the route cause, and to take the

appropriate actions for future analysis

SOP for Karl Fischer apparatus

SOP for L.O.D. oven

SOP for Microbial Limit Test of Raw material and Finished product

SOP for Microbial analysis of swab samples from equipment surfaces

SOP for Microbial assay

SOP for Microbial staining procedures

SOP for Microbiology start up procedure after shut down

Page 13: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for Monitoring of Compressed Air/Gases for Microbiological, Non-Viable Particulate, Oil and

Moisture Content

SOP for Monitoring of microbiology laboratory

SOP for Operating and cleaning of distilled water unit

SOP for Operation & Maintenance Of Fogger

SOP for Operation and Calibration of Analytical Balance

SOP for Operation and Calibration of Conductivity meter

SOP for Operation and Calibration of Conductivity meter

SOP for Operation and Calibration of Micropipette

SOP for Operation and Calibration of Top Pan Balance

SOP for Operation and Calibration of pH meter

SOP for Operation and Cleaning of Air Sampler SAS 180 L

SOP for Operation and Cleaning of Colony Counter

SOP for Operation and Cleaning of Deep Freezer

SOP for Operation and Cleaning of Garment Cubicle

SOP for Operation and Cleaning of Incubator

SOP for Operation and Cleaning of Microscope

SOP for Operation and Cleaning of Microscope

SOP for Operation and Cleaning of Pass box

SOP for Operation and Cleaning of Steam Sterilizer

SOP for Operation and Cleaning of Triobloc

SOP for Operation and Cleaning of Vertical Portable Autoclave

SOP for Operation and Maintenance of Fogger

SOP for Operation and Maintenance of Sterilization Reel Sealer

SOP for Operation and Maintenance of Water Purification System

SOP for Operation and Performance qualification of Biomerieux Kit (mini API, Densimat and

Electronic pipette)

SOP for Operation and calibration of leak tester

SOP for Operation of Milliflex Water filtration Unit

SOP for Operation of Rady Count Down Timer

SOP for Operation, Cleaning and Monitoring of Bio-Safety Cabinet

SOP for Operation, Cleaning and Monitoring of Laminar Air Flow

SOP for Operation, Maintenance & Calibration of Heating Block

SOP for Personnel Qualification of personnel entering into Aseptic area and Sterility Testing area

SOP for Planning for analysis and reporting of result

SOP for Post Sterility Growth Promotion Test

SOP for Preparation of Culture Inoculum

SOP for Preparation of Trends

SOP for Preparation, Review and Approval of Standard Operating Procedures

SOP for Procedure For Bioburden, BET, And LPC Of Primary Packaging Materials

SOP for Procedure for Bacterial Endotoxin (LAL) test

SOP for Procedure for Changeovers carried out in Manufacturing and Packing area

SOP for Procedure for Die Blocking

SOP for Procedure for Handling Of Out Of Specification Results In Microbiological Testing

Page 14: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for Procedure for Handling of Out Of Limit Results in Environmental Monitoring and Water

Analysis.

SOP for Procedure for Manufacturing of Tablets & Capsules

SOP for Procedure for Operation of Air Sampler

SOP for Procedure for Operation of Deduster Cum Metal Detector

SOP for Procedure for Operation of Tablet Branding Machine

SOP for Procedure for Operation, Calibration, and System Suitability of Total Organic Carbon (TOC)

Analyser

SOP for Procedure for Receipt of Raw and Packing Material

SOP for Procedure for Stereo Ordering, Issue, Receipt & Destruction of Rubber Stereos

SOP for Procedure for Storage and Preparation of Microbiological Culture Media

SOP for Procedure for Testing of Biological Indicators

SOP for Procedure for analysis of Water

SOP for Procedure for preparation of dresses for sterilization.

SOP for Procurement, Maintenance and Sub-culturing of Standard Microbial Cultures

SOP for Sampling and Testing of Pure Steam

SOP for Sterility Testing By Membrane Filtration Method

SOP for Sterility Testing Using Manifold For Dilution Study and Stability

SOP for Sterility testing of compressed air, Nitrogen & Carbon dioxide

SOP for Sterility using Streitest Equinox

SOP for Sterilization by Autoclaving for Microbiological testing

SOP for Swab sampling for validation of test surface to evaluate cleaning efficacy.

SOP for Temperature, Humidity and Differential Pressure Monitoring

SOP for Testing of Particulate Matter in Injections and Operation and Maintenance of Liquid Particle

Counter

SOP for Validation Process For Checking Effectiveness Of Disinfections / Cleaning Procedure

SOP for a procedure for preparation of the volumetric solutions

SOP for action to be taken during unusual observation for instrument during calibration

SOP for allocating identification number to instrument/ equipment

SOP for autoclave

SOP for bacteriological incubator

SOP for behaviour in quality control department

SOP for calibration Total Organic Carbon (TOC) Analyser

SOP for calibration coulter counter

SOP for calibration of HPLC column oven

SOP for calibration of halogen moisture analyzer

SOP for calibration of pH meter temperature sensor

SOP for calibration of Atomic absorption spectrophotometer (AAS)

SOP for calibration of Autotitrator

SOP for calibration of Brook field viscometer

SOP for calibration of Gas chromatograph

SOP for calibration of HPLC (low pressure quaternary gradient liquid chromatograph)

SOP for calibration of Head Space Gas Chromatograph

SOP for calibration of Mercury filled glass thermometer

SOP for calibration of Micropipettes

Page 15: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for calibration of Polarimeter

SOP for calibration of automatic box compression strength tester (digital model)

SOP for calibration of autotitrator

SOP for calibration of balance

SOP for calibration of balance

SOP for calibration of bursting strength tester

SOP for calibration of conductivity TDS meter

SOP for calibration of conductivity meter

SOP for calibration of disintegration test apparatus

SOP for calibration of glassware

SOP for calibration of hardness tester

SOP for calibration of high performance thin layer chromatography

SOP for calibration of infrared moisture balance

SOP for calibration of infrared spectrophotometer

SOP for calibration of karl fischer apparatus

SOP for calibration of melting point apparatus

SOP for calibration of pipettes, burettes and volumetric flasks used in Quality control

SOP for calibration of plunger operated pipette

SOP for calibration of refractometer

SOP for calibration of refractometer

SOP for calibration of slit – to – agar air sampler

SOP for calibration of the refractometer

SOP for calibration of walk-in- incubators 20-25°c and 30-35°c

SOP for calibration pH meters

SOP for calibration procedure of u.v.cabinet

SOP for calibration programme

SOP for careful handling of poisonous chemicals

SOP for centrifuge machine

SOP for check suitability of dissolution test apparatus

SOP for check the Fertility properties of the procured Media

SOP for cleaning

SOP for cleaning and disinfection

SOP for cleaning and c) c- 35 operation of BOD incubator (30

SOP for cleaning and operation of RLAF unit in Sampling Room

SOP for cleaning and operation of bio- safety cabinet

SOP for cleaning and operation of incubator

SOP for cleaning and sanitization of microbiology section

SOP for cleaning for DHS

SOP for cleaning in microbiology section

SOP for cleaning of Autodiluter

SOP for cleaning of Dispensing & Sampling Room

SOP for cleaning of Halogen Moisture Analyser

SOP for cleaning of Metrohm Karl fisher

SOP for cleaning of Quality Control Dept. throughout working

SOP for cleaning of Vertical Autoclave

Page 16: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for cleaning of autoclave

SOP for cleaning of automatic distillation apparatus

SOP for cleaning of box compression strength tester

SOP for cleaning of colony counter

SOP for cleaning of disintegration test apparatus

SOP for cleaning of disintegration test apparatus

SOP for cleaning of dispensing utensils

SOP for cleaning of dissolution tester

SOP for cleaning of fourier transform infrared spectrophotometer

SOP for cleaning of friability test apparatus

SOP for cleaning of high performance liquid chromatography (HPLC)

SOP for cleaning of melting point apparatus

SOP for cleaning of microscope

SOP for cleaning of oven for incubator at 55°c

SOP for cleaning of oven for depyrogenation

SOP for cleaning of slit to agar air sampler

SOP for cleaning of steritest

SOP for cleaning of tablet hardness tester

SOP for cleaning of tap density apparatus

SOP for cleaning procedure for karl fischer apparatus

SOP for cleaning procedure for Alu-Alu Packing Machine

SOP for cleaning procedure for Automatic Cartoning Machine

SOP for cleaning procedure for Automatic Coating System

SOP for cleaning procedure for Bins & HDPE Containers

SOP for cleaning procedure for Blister Packing Machine

SOP for cleaning procedure for Checkweigher

SOP for cleaning procedure for Colloidal Mill

SOP for cleaning procedure for Conveyor Belt

SOP for cleaning procedure for Deblistering machine

SOP for cleaning procedure for Deburring and Dedusting Machine

SOP for cleaning procedure for Dehumidifier

SOP for cleaning procedure for Drum mixer

SOP for cleaning procedure for EPD Collator machine with strip packing machine line

SOP for cleaning procedure for Exhaust Ducts in Coating area

SOP for cleaning procedure for FBD Bag

SOP for cleaning procedure for Fluidised bed Dryer

SOP for cleaning procedure for Hose Pipe Of Dust Extraction System

SOP for cleaning procedure for Metal Detector

SOP for cleaning procedure for Mini roll compactor

SOP for cleaning procedure for Octagonal Blender

SOP for cleaning procedure for Paste Kettle

SOP for cleaning procedure for Pressure Vessel, Peristaltic Pump & spraying gun

SOP for cleaning procedure for Rapid Mixer Granulator (R.M.G.)

SOP for cleaning procedure for S.S. Vessel and Utensils

SOP for cleaning procedure for Semi-Automatic Cartoning Machine

Page 17: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for cleaning procedure for Stirrer

SOP for cleaning procedure for Strip Packing Machine

SOP for cleaning procedure for Tablet Compression Machine

SOP for cleaning procedure for Vacuum Cleaner

SOP for cleaning procedure for Vibro Sifter

SOP for cleaning procedure for brooke field viscometer

SOP for cleaning procedure for cad mill

SOP for cleaning procedure for capsule filling cubicle

SOP for cleaning procedure for capsule filling line

SOP for cleaning procedure for centrifuge

SOP for cleaning procedure for coulter counter

SOP for cleaning procedure for dissolution test apparatus

SOP for cleaning procedure for gas chromatograph (head space)

SOP for cleaning procedure for heating block

SOP for cleaning procedure for high performance thin layer chromatograph

SOP for cleaning procedure for microbiological laboratory other than clean area.

SOP for cleaning procedure for microscope

SOP for cleaning procedure for multi mill

SOP for cleaning procedure for pallet

SOP for cleaning procedure for polarimeter

SOP for cleaning procedure for refracto meter

SOP for cleaning procedure for semi auto induction cap sealing machine

SOP for cleaning procedure for tablet counter

SOP for cleaning procedure for u.v. /visible spectrophotometer

SOP for cleaning procedure for u.v. /visible spectrophotometer

SOP for cleaning procedure for ultrasonic bath

SOP for cleaning procedure for vacumme oven

SOP for cleaning procedure for water bath

SOP for cleaning procedure for water purification system

SOP for cleaning procedure for zone reader

SOP for cleaning procedure of atomic absorption spectrophotometer

SOP for cleaning procedure of balances

SOP for cleaning procedure of bursting strength tester

SOP for cleaning procedure of deep freezer

SOP for cleaning procedure of polariscope

SOP for cleaning procedure of puncture resistance tester

SOP for cleaning procedure of quardrant meter

SOP for cleaning procedure of sterile dress cabinate

SOP for cleaning procedure of water bath

SOP for cleaning, operation and calibration of Antibiotic Zone Reader

SOP for collection and storage of retained samples of packaging material

SOP for collection and storage of retained samples of raw material

SOP for collection of swab sample

SOP for control of master data generation by computer system

SOP for destroy the inprocess, finished product and raw materials samples timely after testing

Page 18: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for destruction of control samples (Raw material and Finished product)

SOP for dispatch the Finished Goods out side the factory premises from BSR

SOP for dispensing and issuing of Packing Material as per the requirement from Production

Department

SOP for disposal of empty media conatiner

SOP for disposal of expired chemicals, reagents, solvents and micro-biological medium.

SOP for disposal of microbial culture media and cleaning of glassware used for culture media

SOP for disposal of rejected Packing Material

SOP for disposal procedure for media containing growth

SOP for entry and exit in Microbiological Testing Area (MLT/Sterility Room)

SOP for entry and exit in Microbiology Section

SOP for environmental monitoring of aseptic area by air sampling for viable count using air sampler

SOP for environmental monitoring of dispensing and sampling area in raw materials

SOP for environmental monitoring of manufacturing area of solid dosage form by settling plate count

SOP for environmental monitoring of solid dosage form area by non viable air particle count

SOP for environmental monitoring of walk-in-incubators

SOP for evaluation of compressed air in manufacturing of Pharmaceutical products

SOP for evaluation of environmental monitoring results (trend analysis)

SOP for for allocating document protocol number for instrument qualification

SOP for for measurement of particle size of raw materials using microscopic method

SOP for general test procedure

SOP for gowning procedure

SOP for gowning procedure for the visitors

SOP for growth promotion test and calibration of inoculum

SOP for guideline for storage condition of raw material

SOP for guideline for the system suitability test for HPLC analysis

SOP for guidelines for Microbiology laboratory

SOP for hand wash procedure

SOP for handling & usage of hazardous chemicals

SOP for handling and control for the prohibited items

SOP for handling and testing of inprocess sample

SOP for handling and testing of various samples

SOP for handling of biological indicators

SOP for handling of glassware

SOP for handling of reference and working standard

SOP for handling of spillage of solid/liquid media containing growth

SOP for handling of the spillages in the laboratory

SOP for heat distribution study in chamber of depyrogemation oven using different probe with data

logger

SOP for heat distribution study in chamber of dry heat sterilizer using different probe with data logger

SOP for heat distribution study in oven using multi probe data logger

SOP for heating block validation

SOP for hplc column receipt checking and regeneration

SOP for identification of contaminant in sterile area

SOP for identification of organisms

Page 19: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for instrument for macroscopical examination

SOP for inventory and issuances of media in quality control lab

SOP for investigation for out of action level results of monitoring of micro biological environment

SOP for investigation of sterility test failure

SOP for laboratory cleaning

SOP for laboratory safety

SOP for lal test by gel clot method

SOP for laminar air flow workstation

SOP for leak seal test apparatus

SOP for leak test of strip, blister and alu – alu blister sealing

SOP for logic for giving number to the method for analysis of finished product and raw material

SOP for logic for giving number to the method for analysis of packaging material

SOP for maintenance & cleaning procedure for sampling equipment

SOP for maintenance and transfer of stock cultures

SOP for maintenance of desiccator

SOP for manual glassware cleaning procedure

SOP for media disposal

SOP for media preparation

SOP for media preparation

SOP for media stock maintenance and suitability testing of media

SOP for method for programme file checks of software of instruments

SOP for metone laser particle counter

SOP for microbial limit test for raw materials and finished products

SOP for microbial monitoring of drainage in solid dosage manufacturing area

SOP for microbiological integrity testing of vials

SOP for microbiological monitoring of clean equipment in to solid dosage area. – swab method

SOP for microscope

SOP for monitoring UV Light Efficiency LAF & Pass Box

SOP for muffel furnace

SOP for numbering system of media

SOP for operating procedure of Dehumidifier

SOP for operating procedure of colony counter

SOP for operating procedure of culture cabinet

SOP for operating procedure of data logger

SOP for operating procedure of double door autoclave

SOP for operating procedure of fogster –ULV fogger machine

SOP for operating procedure of laminar air flow

SOP for operating procedure of water bath.

SOP for operation & calibration of digital Colony Counter

SOP for operation and calbration of dry bath

SOP for operation and calibration of bulk density apparatus

SOP for operation and calibration of bursting strength tester

SOP for operation and calibration of friability test apparatus

SOP for operation and calibration of pH meter (GMPH)

SOP for operation and calibration of pH meter (pH tutor)

Page 20: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for operation and calibration of tablet disintegration apparatus

SOP for operation and calibration of vacuum oven

SOP for operation and cleaning of LAF unit in Sampling Room

SOP for operation and cleaning of Refrigerator

SOP for operation and monitoring of performance of dynamic pass box

SOP for operation and monitoring of performance of garment cabinet

SOP for operation of Laminar Air Flow

SOP for operation of centrifuge machine

SOP for operation of magnetic stirrer with hot plate

SOP for operation of micrometer

SOP for operation of particle counter

SOP for operation of sampling booth

SOP for operation of sonicator

SOP for operational check of disintegration test apparatus

SOP for operational check of friability test apparatus

SOP for operational qualification of dissolution tester

SOP for oven for depyrogenetion

SOP for oven for incubation at 55 deg c

SOP for palm swabbing

SOP for performance check of karl fisher

SOP for performance check of UV - visible spectrophotometer (Jasco)

SOP for performance check of UV/visible spectrophotometer

SOP for performance check of autodiluter

SOP for performance check of fourier transform infrared

SOP for performance checks of karl fischer apparatus

SOP for performance of low temperature water bath

SOP for personnel monitoring in aseptic area

SOP for physical monitoring of microbiology section

SOP for plate exposure

SOP for preparation and handling of primary standard

SOP for preparation and standardisation of volumetric solutions

SOP for preparation of Culture dilutions

SOP for preparation of Rejection Note

SOP for preparation of bench reagents

SOP for preparation of microbial culture media

SOP for preparation of sterile petridishes, agar slants and agar butts

SOP for preparation, approval, issue, control, uncontrol and revision of quality manual

SOP for preservation of Control samples of Active ingredients

SOP for procedure environmental monitoring of parenteral processing area : by settling plate count

method.

SOP for procedure for Handling of Lysate.

SOP for procedure for Material and Product Labeling in Production department

SOP for procedure for Operation and cleaning of Automatic Batch Printing Machine

SOP for procedure for Operation of Alu Alu blister pack machine

SOP for procedure for Operation of Automatic Capsule Filling Line

Page 21: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for procedure for Operation of Automatic Coating System (NEOCOTA 48”)

SOP for procedure for Operation of Batch Printing Machine (Semi Automatic)

SOP for procedure for Operation of Colloid Mill

SOP for procedure for Operation of Compression Machine 20 station (Single Rotary Type)

SOP for procedure for Operation of Compression Machine 27 station (Double Rotary Type)

SOP for procedure for Operation of Deblistering Machine

SOP for procedure for Operation of Deburring & Dedusting Machine

SOP for procedure for Operation of Drum mixer

SOP for procedure for Operation of Fluidised Bed Dryer

SOP for procedure for Operation of Multimill

SOP for procedure for Operation of Octagonal Blender (1000 liter)

SOP for procedure for Operation of Paste Kettle

SOP for procedure for Operation of Rapid Mixer Granulator (RMG)

SOP for procedure for Operation of Stirrer

SOP for procedure for Operation of Strip Packing Machine

SOP for procedure for Operation of Tablet Inspection machine

SOP for procedure for Operation of Vacuum Test Apparatus

SOP for procedure for Operation of Vibro Sifter

SOP for procedure for Operation of Volume Delivering Systems (Peristaltic Pump)

SOP for procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies & Punches

SOP for procedure for Packing of Tablets/Capsules in strip pack or blister pack as primary packing &

packing of strips or blisters in cartons, shipper as secondary packing

SOP for procedure for Pre Filter cleaning of RLAF

SOP for procedure for Receipt, Issuance, Storage and Handling of solvent

SOP for procedure for Tablet Inspection

SOP for procedure for Tablet granulation, compression and coating

SOP for procedure for action to be taken during spillage/breakage of materials

SOP for procedure for analyst validation

SOP for procedure for calibration of thermometer

SOP for procedure for challenge test of solid Flow Monitor in Fluid Bed Dryer

SOP for procedure for cleaning and storage of flexible pipes

SOP for procedure for cleaning of barrel pump & pipe

SOP for procedure for cleaning of clean area

SOP for procedure for cleaning of equipment and accessories in Production Area

SOP for procedure for conduct a temperature mapping exercise in store to identify the location of the

worst point at which the thermometer and hygrometer for daily monitoring needs to be placed

SOP for procedure for destruction of online rejects of printed and overprinted packaging materials

SOP for procedure for disposal of wastage and transfer to ETP

SOP for procedure for entering in inoculation room

SOP for procedure for entering in sterility testing room

SOP for procedure for environmental monitoring of aseptic area :non viable particle count of air

SOP for procedure for environmental monitoring of aspetic area: finger prints and gown sampling

SOP for procedure for environmental monitoring of clean area and LAF modules.

SOP for procedure for environmental monitoring of parenteral processing area : surface testing by

means of rodac plate and swab

Page 22: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for procedure for evaluation of analyst’s performance

SOP for procedure for fumigation in microbiology lab

SOP for procedure for handling of Rejected Packing Materials

SOP for procedure for handling of Rejected Raw Material

SOP for procedure for handling of Tablet Counter

SOP for procedure for handling of sieves and screen

SOP for procedure for house-keeping of stores

SOP for procedure for issuance of additional packaging materials

SOP for procedure for linearity check of high performance liquid chromatograph

SOP for procedure for maintaining machine use log

SOP for procedure for making production related entries in SAP system

SOP for procedure for operating and cleaning of Vacuum Cleaner

SOP for procedure for operation and calibration of precision oven

SOP for procedure for operation and cleaning of Carton Sealing Machine

SOP for procedure for operation of Cad mill

SOP for procedure for operation of EPD Collator coupled with strip packing machine

SOP for procedure for operation of conveyor belt in packing

SOP for procedure for operation of mini roll compactor

SOP for procedure for operation of semi auto induction cap sealing machine

SOP for procedure for operation of ‘Bliss’, the online inspection system

SOP for procedure for overprinting of batch details on cartons and catch covers

SOP for procedure for performance of automatic distillation apparatus

SOP for procedure for preparation and handling of working standard

SOP for procedure for proper disposal of expired finished goods

SOP for procedure for receipt, numbering, usage and destruction of FBD filter bag

SOP for procedure for recleaning

SOP for procedure for reconciliation of Raw Materials and Packing Materials

SOP for procedure for recording of Temperature & Humidity in Stores Department

SOP for procedure for recording of Temperature and Humidity in Raw Material Store and

Temperature recording in Packing Material Store for maintaining proper storage conditions

SOP for procedure for recording of Temperature in Production Department

SOP for procedure for recording of differential pressure in Production area.

SOP for procedure for return of Raw & Packing materials from production department

SOP for procedure for safely and effectively clean and disinfect the drains

SOP for procedure for sampling and testing schedule of water for injection and clean steam

SOP for procedure for sampling of the packaging material

SOP for procedure for sieve analysis

SOP for procedure for stacking of packed shippers on pallet

SOP for procedure for stenciling of shippers used for packing

SOP for procedure for sterility testing

SOP for procedure for storage & transference of dispensed raw material in day store

SOP for procedure for storage of temperature sensitive raw materials

SOP for procedure for the Blister Pack Machine

SOP for procedure for the intimation of break down of utilities services & equipments in manufacturing

& packing department during working

Page 23: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for procedure for the operation of Automatic Cartoning Machine

SOP for procedure for the operation of Semi-Automatic Cartoning Machine (VP-120)

SOP for procedure for the operation of checkweigher

SOP for procedure for the preventive maintenance of all quality control instruments

SOP for procedure for transfer of the finished goods to bonded store room

SOP for procedure for validation of microbiologist

SOP for procedure for vehicle Inspection

SOP for procedure for washing the HPLC column after use

SOP for procedure of fumigation in production area by using 5 % Gramicid and Fogger

SOP for procedure of sampling of raw material

SOP for procedure to specify the responsibilities of production department

SOP for procurement and handling of reference standard

SOP for proper disposal of contaminated material to ensure all media containing microbial growth are

disposed properly

SOP for qualification of Biological Indicator

SOP for quantification of culture

SOP for raw material release

SOP for receipt and maintenance of working standards of API

SOP for receiving the samples in microbiology lab

SOP for release of finished product

SOP for retesting of Raw Materials

SOP for retesting schedule of packaging material

SOP for retesting schedule of raw material

SOP for retesting schedule of raw material (for API)

SOP for rounding off the analytical test results

SOP for routine cleaning verifictaion by TOC-SSM method

SOP for safety in quality

SOP for sampling and release of Inprocess samples

SOP for sampling and release of raw materials

SOP for sampling and testing schedule of purified water

SOP for sampling of Finished product

SOP for sampling of packing material

SOP for sampling of water

SOP for selection criteria and its procedure before dissolution profile study

SOP for slit to agar air sampler

SOP for statistical study for trend analysis of purified water and water for injection

SOP for steam penitration study by bowie-dick test

SOP for sterile dress cabinet

SOP for sterilization of accessories by dry heat sterilization

SOP for storage and use of reagents & chemicals

SOP for subculturing & maintenance of microbial cultures

SOP for testing & release/rejection of Finished product

SOP for testing for bioburden of fractional solutions

SOP for testing of compressed air and nitrogen gas for viable count

SOP for testing of miscellaneous sample

Page 24: Pharma Manual.pdf

Index of all Pharmaceutical Guidelines. Click on Guideline to Open.

www.pharmaguideline.com

SOP for the procedure for Operation of Rapid Mixer Granulator

SOP for training procedure for qc persons

SOP for trend analysis

SOP for ultrasonic cleaner

SOP for use of logcard for equipment status

SOP for validation of DHS with biological indicator

SOP for validation of autoclave

SOP for validation of autoclave with biological-indicator

SOP for validation of clean area & equipment lying in clean area

SOP for validation of oven for depyrogeneation.

SOP for verification of system suitability test

SOP for verification of system suitability test measured by chrom card software for GC

SOP for vortex mixer

SOP for water sampling procedure

SOP for writing method of analysis for P.M

SOP of SOP (SOP on SOP) in Pharmaceuticals

SOP on Standard Operating Procedure

SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V