6/15/15 LECTURECebu Doctors’ University

OBJECTIVES

• Understand the fundamentals of the quality control analysis in the pharmaceutical industry.

• Explain the different functions of quality control division.

• Explain the importance of quality control in pharmaceutical manufacturing firms.

• Review scope of CGMP

OBJECTIVES

• Point out governing bodies for quality approval.

Walter Shewhart

• Father of statistical quality Contol

• The originator of Quality Control via control charts.

• He described Quality as having both objective and subjective.

OBJECTIVE

• Measurement of specifications within a minimum validation from target values.

Ex. Weight of the dosage formSize shape of the dosage formMoisture content

SUBJECTIVE

• Commercial value

( functions of, cost, use and aesthetics.)

QUALITY

• Fitness for use

• Conformance to

Requirements

• Usefulness at a reasonable cost

• Freedom from deficiencies

QUALITY

• Acceptance to outstanding service

• Customer satisfaction

QUALITY CONTROL

• Assessment of all operations beginning with the receipt of the raw materials to production, packaging, finished product testing, documentation , surveillance and destruction.

Benefits of QC

1. The system eliminates the risk of marketing unsafe products

2. Guarantees conformance to regulatory requirements.

Benefits of QC

Benefits of QC

3. Guarantees product efficacy

Benefits of QC

Benefits of QC

4. Reduces operating cost

Benefits of QC

Benefits of QC

5. Reduces operating losses.

6. Produces higher employees morale

Benefits of QC

Benefits of QC

7. Motivate pharmaceutical/ med profession to sell/ prescribe the product

Benefits of QC

Stability testing

• Provides evidence on how the drug substance or product quality varies with time under environmental conditions during distribution.

• Helps to recommend storage conditions including establishment of shelf life, expiry date or retest period.

• Key assurance of quality of pharmaceuticals.

QUALITY ASSURANCE

• Systems, facilities and written procedures that should be practice according to standard that conforms to specifications.

QA versus QC

• Prevent defects on the process

• To improve development and test

• Identify defects in the finished product.

• Identify defects after the product in development and before its release.

ORGANIZATIONAL CHART OF QC DEPARTMENT

QC MANAGER

ANALYTICAL CONTROL

INSPECTION CONTORL ON RAW MATERIALS

BIOLOGICAL TESTING LAB

SPECIFICATION AND ANALYTICAL DEVELOPMENT

QUALITY COORDINATING OFFICEOr CONTROL RELEASE OFFICER

TOTAL QUALTIY CONTROL

• Organized effort within an entire establishment to design, produce, maintain and assure the specified quality in each unit of product distributed.

TOTAL QUALITY MANAGEMENT

• TOTAL= involves everyone and all activities in the company.

• QUALITY= conformance to requirements

(meeting customer requirements)

• MANAGEMENT= quality must and can be managed

TOTAL QUALITY MANAGEMENT

• A process for managing quality

• It must be a continuous way of life; a philosophy of perpetual improvement in everything.

Scope of CGMP

A. Definition of terms

QA -

QC -

TQC -

TQM -

SPC -

LCL -

AQL -

A. Definition of terms

PONC -

POC -

B. ORGANIZATION and PERSONNEL1. Responsibilities of QC unit

- Assignment for TQC to assure product quality

2. Personnel Qualifications

- Training/ experience supervisory to operational

B. ORGANIZATION and PERSONNEL3. Personnel responsibilities

- Hygiene, clothing, medical status

4. Consultants

- Approved by QC

(qualifications)

C. BUILDING and FACILITIES

1. Design and construction features

2. Lighting

3. Ventilation, air filtration,

Air heating and cooling

C. BUILDING and FACILITIES

C. BUILDING and FACILITIES

4. Plumbing

5. Sewage and refuse

6. Washing and toilet facilities

C. BUILDING and FACILITIES

7. Sanitation

8. Maintenance

D. EQUIPMENT

1. Design, size and location

2. Construction

3. Cleaning maintenance

4. Automatic/ mechanical/ electrical equipment

5. Filters

E. CONTROL FOR DRUG PRODUCT CONTAINERS and CLOSURES• Written procedures must be available 1. Receipt of untested components, storage

containers and closures.2. Testing and approval or rejection3. Use4. Retesting5. Rejection6. Drug product container

F. PRODUCTION and PROCESS CONTROL1. Written procedures

-SOPS

Any changes in the SOP should be:

- Investigated

- Recorded

- Approved prior to final product acceptance

Benefits of SOP

• Provide continual development of operations

• Improve of communication with employees

• Simplify new employee training

• Share experience knowledge and ideas

Typical structure of SOP

• Title page

• Company logo

• Header and title of SOP

• Department name

• Effective date

• Revision date

• Review date

Typical structure of SOP

• Page no

• Regulatory basis

• Reference documents

• Purpose

• Scope

• Responsibilities and accountabilities

• Procedures

Typical structure of SOP

• FooterApproving signatures-Prepared by-Checked by-Approved by

• StampControlled copy/ master copyQA stamp

F. PRODUCTION and PROCESS CONTROL2. Change in components-Calculation of Yield-Equipment identification-Sampling and Testing in-process materials

and drug product-Time limitation on production-Control of microbial contamination-Reprocessing

G. PACKAGING and LABELLING CONTROL1. Materials examination and usage criteria

2. Labelling Criteria

3. Packaging and Labelling operations

4. Drug product inspection

5. Expiration dating

H. HOLDING and DISTRIBUTION

1. Warehousing procedures

2. Distribution procedures

I. LABORATORY CONTROLS

1. Stability testing

2. Special testing requirements

I. LABORATORY CONTROLS

3. Reserve samples

4. Laboratory animals

5. Penicillin contamination

J. RECORDS and REPORTS

1. Equipment cleaning and use

2. Component, drug container, closure, labelling records

3. Waste production and control records

J. RECORDS and REPORTS

4. Production record review

5. Laboratory records

6. Distribution record

7. Compliant file

K. RETURNED and SALVAGED DRUG PRODUCT1. Returned Drug Products

- Records, reason for return used as part of the total lot accountability

- Tracing of its distribution/ recall

K. RETURNED and SALVAGED DRUG PRODUCT2. Drug product salvaging

- Due to its improper storage, drug should not or not to be salvaged.