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Mohammad Khalid Anwer, Ph.D e-mail:- mkanwer2002@yahoo.co.in

Mohammad Khalid Anwer, Ph.D e-mail:- mkanwer2002@yahoo.co.in

SALMAN BIN ABDULAZIZ UNIVERSITY

COLLEGE OF PHARMACY

1- Material:1- Material:

A term used to cover starting materials, A term used to cover starting materials,

intermediate products, packaging materials intermediate products, packaging materials

and finished productsand finished products

2- Starting Material: 2- Starting Material:

Any substance used in the manufacture of a Any substance used in the manufacture of a

medicinal medicinal

product excluding packaging materials.product excluding packaging materials.

3- In-Process Material:3- In-Process Material:

Means any material fabricated, compounded, Means any material fabricated, compounded,

blended, or derived by chemical reaction that is blended, or derived by chemical reaction that is

produced for, and used in the preparation of the produced for, and used in the preparation of the

drug product.drug product.

INDUSTRIAL PHARMACY TERMINOLOGYINDUSTRIAL PHARMACY TERMINOLOGY

4- Packaging Material :4- Packaging Material :

Any material used in the packaging of a Any material used in the packaging of a

product. It does not normally include the product. It does not normally include the

outer packaging or transit cases used for outer packaging or transit cases used for

departmental transportation or shipment of departmental transportation or shipment of

orders.orders.

(a)(a) Primary Packaging Material: Primary Packaging Material:

Which is in direct with Which is in direct with

medicinal product.medicinal product.

(b) Printed Packaging Material: (b) Printed Packaging Material:

A packaging material which A packaging material which

is imprinted with a text. is imprinted with a text.

5- Active Ingredient:5- Active Ingredient:

Means any component that is intendedMeans any component that is intended

to give pharmacological activity. to give pharmacological activity.

6 - Inactive Ingredient : 6 - Inactive Ingredient :

Means any component other thanMeans any component other than

an "active ingredient" .an "active ingredient" .

7- Dosage Form:7- Dosage Form:

Refers to the physical form in which Refers to the physical form in which

a drug is administered to or used by a drug is administered to or used by

a patient.a patient.

7- Intermediate Product:7- Intermediate Product:

A partly processed material which A partly processed material which

must undergo further processing must undergo further processing

before it becomes a finished product.before it becomes a finished product.

8- Drug Product:8- Drug Product:

A dosage form containing one or A dosage form containing one or

more active therapeutic ingredients more active therapeutic ingredients

along with other substances included along with other substances included

during the manufacturing process.during the manufacturing process.

9- Finished Product:9- Finished Product:

A medicinal product which has completed all A medicinal product which has completed all

stages of manufacture, including packaging.stages of manufacture, including packaging.

10- Batch: 10- Batch: Means a specific quantity of a drug Means a specific quantity of a drug

and/or other material that is intended to and/or other material that is intended to

have uniform character and quality, within have uniform character and quality, within

specified limits , and is produced according specified limits , and is produced according

to a single manufacturing order during the to a single manufacturing order during the

same cycle of manufacture.same cycle of manufacture.

11- Lot : A batch11- Lot : A batch

It is a specific identified amountIt is a specific identified amount

produced in a unit of time or quantity in a produced in a unit of time or quantity in a

manner that assures uniform character and manner that assures uniform character and

quality within specified limits.quality within specified limits.

12- Lot Number:12- Lot Number: "Control Number, or Batch "Control Number, or Batch

Number"Number"

Means any distinctive combination of Means any distinctive combination of

letters, numbers, or symbols, or any letters, numbers, or symbols, or any

combination of them, from which the combination of them, from which the

complete history of the manufacture, complete history of the manufacture,

processing, packing, holding, and processing, packing, holding, and

distribution of a batch or lot of drug distribution of a batch or lot of drug

product or other material can be product or other material can be

determined.determined.

13- "Manufacture, Processing, Packing or 13- "Manufacture, Processing, Packing or

Holding of a Drug Product“Holding of a Drug Product“

Includes packaging and labeling Includes packaging and labeling

operations, testing, and quality control of operations, testing, and quality control of

drug products.drug products.

14- Strength :14- Strength :

The concentration of the drug substance The concentration of the drug substance

(weight/weight, weight/volume, or unit (weight/weight, weight/volume, or unit

dose/volume basis).dose/volume basis).

The potency, that is the therapeutic The potency, that is the therapeutic

activity of the drug product as indicated by activity of the drug product as indicated by

appropriate laboratory tests or by appropriate laboratory tests or by

adequately developed and controlled adequately developed and controlled

clinical data (expressed, in terms of units clinical data (expressed, in terms of units

by reference to a standard).by reference to a standard).

15- Storage :15- Storage : The term is applied for safe The term is applied for safe

keeping of material and drug products in keeping of material and drug products in

drug stores, Pharmacies, hospitals ...etc. drug stores, Pharmacies, hospitals ...etc.

under the specified conditions.under the specified conditions.

16- Storage Conditions: 16- Storage Conditions:

The conditions specified for storingThe conditions specified for storing

The product (Temperature, humidity, The product (Temperature, humidity,

container etc.)container etc.)

17- Stability : 17- Stability :

The stability of a pharmaceutical preparation The stability of a pharmaceutical preparation

is: is:

its degree of resistance to chemical its degree of resistance to chemical

and and

physical changes. physical changes.

The efficacy of the preparation must The efficacy of the preparation must

remain remain

constant (constant (or change only within the or change only within the

limits limits

specified by legal provisionsspecified by legal provisions) until the ) until the

date of date of

expiration.expiration.

18- Stability Indicating Assay : 18- Stability Indicating Assay :

The assay which is sensitive and selective The assay which is sensitive and selective

too too

determine quantitatively the active determine quantitatively the active

ingredient ingredient

in the presence of its decomposition in the presence of its decomposition

products.products.

19- Shelf-Stability :19- Shelf-Stability :

The stability of the drug or drug product The stability of the drug or drug product

at ambient room temperature (15-35°C).at ambient room temperature (15-35°C).

20- Overage : 20- Overage :

The excess quantity of drug that must be The excess quantity of drug that must be

added to the preparation to maintain at added to the preparation to maintain at

least 100% of' the labeled amount during least 100% of' the labeled amount during

the expected shelf-life of the drug.the expected shelf-life of the drug.

21- Expiration Date : 21- Expiration Date :

The date placed on the container label of a The date placed on the container label of a

drug product that designates the date through drug product that designates the date through

which thewhich theproduct is expected to remain product is expected to remain

within specifications. If the within specifications. If the

expiration date includes only a expiration date includes only a

month and a year, it is expected month and a year, it is expected

that the product will meet that the product will meet

specifications through the last day specifications through the last day

of the month. Kinetically it is the of the month. Kinetically it is the

time required for 10% of the time required for 10% of the

material to disappear.material to disappear.

22- Accelerated Testing :(Stress 22- Accelerated Testing :(Stress

Testing) Testing)

Studies designed to increase the Studies designed to increase the

rate of chemical or physical rate of chemical or physical

degradation of a drug substance or degradation of a drug substance or

drug product by using exaggerated drug product by using exaggerated

storage conditions. The purpose is to storage conditions. The purpose is to

determine kinetic parameters, if determine kinetic parameters, if

possible, and/or to predict the possible, and/or to predict the

expiration dating period.expiration dating period.

23- Temperature Control:23- Temperature Control: All Temperatures in All Temperatures in

Degrees.Degrees.

(a) Cold Place: (a) Cold Place: The temperature does not exceed 8".The temperature does not exceed 8".

(b) Refrigerator: (b) Refrigerator: The temperature is thermostatically The temperature is thermostatically

controlled between 2° and 8° .controlled between 2° and 8° .

(c) Freezer: (c) Freezer: The temperature The temperature

is thermostatically controlledis thermostatically controlled

to not higher than - 10 °.to not higher than - 10 °.

(d) Cool Place: (d) Cool Place: The temperature is between 8 ° and 15 The temperature is between 8 ° and 15

°.°.

(e) Warm Place: (e) Warm Place: Any temperature between 30 ° and Any temperature between 30 ° and

40 °40 °

(f) Room Temperature: (f) Room Temperature: The temperature is between The temperature is between

15 ° and 30 ° .15 ° and 30 ° .

(g) Excessive Heat: (g) Excessive Heat: Any temperature above 40 Any temperature above 40 °.°.

24- Good Manufacturing Practice (GMP) : 24- Good Manufacturing Practice (GMP) :

That part of quality assurance aimed at That part of quality assurance aimed at

ensuring that products are ensuring that products are

manufactured, to a quality appropriate to manufactured, to a quality appropriate to

their intended use.their intended use.

25- Quality:25- Quality:

The ability of a drug product to satisfy The ability of a drug product to satisfy

the the

users need.users need.

The emphasis in making pharmaceutical The emphasis in making pharmaceutical

preparations has moved from the individual preparations has moved from the individual

dispenser to the large-scale manufacturer.dispenser to the large-scale manufacturer.

Reasons for Increasing Large-scale ManufactureReasons for Increasing Large-scale Manufacture

Economic ReasonsEconomic Reasons

AccuracyAccuracy

Greater ScopeGreater Scope

Introduction to Industrial ProcessingIntroduction to Industrial Processing

Economic ReasonsEconomic Reasons

As the scale of manufacturing batches increases, As the scale of manufacturing batches increases,

the cost of production decrease. the cost of production decrease.

AccuracyAccuracy

The larger the quantities of materials involved, the The larger the quantities of materials involved, the

accuracy of measurements increased, with accuracy of measurements increased, with

laboratory control during manufacture and testing laboratory control during manufacture and testing

the final product.the final product.

Greater ScopeGreater Scope

The increasing complexity of modern therapy has The increasing complexity of modern therapy has

made it impossible to prepare many medicaments made it impossible to prepare many medicaments

on a small scale as antibiotic production is possible on a small scale as antibiotic production is possible

only on a large scale. only on a large scale.

In the pilot plant, a designed formula is transformed In the pilot plant, a designed formula is transformed

from being manufactured on a laboratory scale, or in from being manufactured on a laboratory scale, or in

intermediate-sized pilot plant equipment into a intermediate-sized pilot plant equipment into a

viable, full-bodied product by the development of a viable, full-bodied product by the development of a

reliable and practical method of manufacture that reliable and practical method of manufacture that

effects the orderly transition from laboratory to effects the orderly transition from laboratory to

routine processing in a full-scale production facilities routine processing in a full-scale production facilities

with high-speed production equipment in a cost-with high-speed production equipment in a cost-

effective mannereffective manner

Pilot Plant Scale-Up TechniquesPilot Plant Scale-Up Techniques

A close examination of the formula to determine its A close examination of the formula to determine its

ability to withstand batch-scale and process ability to withstand batch-scale and process

modification.modification.

A review of a range of processing A review of a range of processing equipmentequipment to to

determine which would be the most determine which would be the most compatiblecompatible

with the formulation as well as the most with the formulation as well as the most

economicaleconomical and and simplesimple in producing the product. in producing the product.

General Considerations in Pilot Plant Studies:General Considerations in Pilot Plant Studies:

During this process some considerations must be During this process some considerations must be

determined:determined:

The availability of raw materials to meet the The availability of raw materials to meet the

specifications required. specifications required.

Production rates and their relationship to Production rates and their relationship to

immediate and future market requirements.immediate and future market requirements.

The physical space required and the The physical space required and the

arrangement of related functions. arrangement of related functions.

The requirements, training, reporting The requirements, training, reporting

relationships and responsibilities of relationships and responsibilities of

personnel. personnel.

PERSONNEL REQUIREMENTS

Personnel in the pilot plant must has the following

the qualifications requirements:

Be aware of the meaning of the formulator.

Understand the view of production personnel.

Level of scientific education.

Pharmaceutically trained scientists know the

interrelationship between pharmaceutical

processes and the chemical, physical, biochemical,

and medical attributes of dosage forms.

Some engineering capability .

Knowledgeable in both electronics and

computers.

Space Requirements

A pilot plant has the following four types of space

requirements.

Administration and Information Processing. Administration and Information Processing.

Physical Testing Area. Physical Testing Area.

Standard Pilot Plant Equipment Floor Space. Standard Pilot Plant Equipment Floor Space.

Storage Area. Storage Area.

Administration and Information Processing.Administration and Information Processing.

Office and desk space must be provided for both the Office and desk space must be provided for both the

scientists and technicians. scientists and technicians.

This should be adjacent to the work area This should be adjacent to the work area

But isolated to permit people to workBut isolated to permit people to work

without distractions.without distractions.

Physical Testing Area. Physical Testing Area.

Is a working area in which samples can be laid out Is a working area in which samples can be laid out

and examined and where physical tests on these and examined and where physical tests on these

samples can be performed.samples can be performed.

Standard Pilot Plant Equipment Floor Space. Standard Pilot Plant Equipment Floor Space.

Is a separate plant space where equipment needed Is a separate plant space where equipment needed

for manufacturing all types of pharmaceutical dosage for manufacturing all types of pharmaceutical dosage

forms is located. forms is located.

The area is The area is

subdivided into subdivided into

areas for solid areas for solid

dosage forms, dosage forms,

semisolid products, semisolid products,

liquid preparations, liquid preparations,

and sterile and sterile

products. products.

Storage Area. Storage Area.

Separate storage area for the of active ingredients Separate storage area for the of active ingredients

and excipients. and excipients.

Storage areas for in-process materials, and Storage areas for in-process materials, and

material from experimental scale-up batches.material from experimental scale-up batches.

Storage for packaging materials. Storage for packaging materials.

Storage areas for finished bulk products.Storage areas for finished bulk products.

Review o f the FormulaReview o f the Formula

The purpose of each ingredient and its contribution The purpose of each ingredient and its contribution

to the final product manufactured on small-scale to the final product manufactured on small-scale

laboratory equipment should be understood. laboratory equipment should be understood.

Raw MaterialsRaw Materials

Approval and validation of the active and excipient Approval and validation of the active and excipient

raw materials used in pharmaceutical products is raw materials used in pharmaceutical products is

necessary.necessary.

Relevant Processing EquipmentRelevant Processing Equipment

The equipment that promises to be the most The equipment that promises to be the most

economical, the simplest, the most efficient, and the economical, the simplest, the most efficient, and the

most capable of consistently producing product most capable of consistently producing product

within the proposed specifications should be within the proposed specifications should be

evaluated. evaluated.

Ease of cleaning should be considered, especially if Ease of cleaning should be considered, especially if

multiple products are destined to be manufactured multiple products are destined to be manufactured

in the equipment. in the equipment.

Production RatesProduction Rates

The immediate and future market requirements must The immediate and future market requirements must

be considered when determining the production be considered when determining the production

rates.rates.

To accommodate future growth, increased To accommodate future growth, increased

production capacity may be realized more production capacity may be realized more

economically through more efficient utilization of economically through more efficient utilization of

smaller equipment than through purchase of smaller equipment than through purchase of

oversized equipment. For example, several smaller oversized equipment. For example, several smaller

lots produced serially (without major clean-up) may lots produced serially (without major clean-up) may

be combined in a final blend to make a single large be combined in a final blend to make a single large

batch.batch.

Process EvaluationProcess EvaluationThe evaluation of the process critically and The evaluation of the process critically and

optimization its performance based on that evaluation.optimization its performance based on that evaluation.

Items that should be examined include the following:Items that should be examined include the following:

Order of addition of components. Order of addition of components.

Adjustment of their amounts.Adjustment of their amounts.

Mixing speed.Mixing speed.

Mixing time.Mixing time.

Rate of addition of granulating agents, solvents, Rate of addition of granulating agents, solvents,

solutions of solutions of

drugs, slurries, etc.drugs, slurries, etc.

Heating and cooling rates.Heating and cooling rates.

Filter sizes (liquids).Filter sizes (liquids).

Screen sizes (solids). Screen sizes (solids).

Drying temperatures.Drying temperatures.

Drying time.Drying time.

Transfer o f Analytic Methods to Quality Transfer o f Analytic Methods to Quality

AssuranceAssurance

Proper analytic instrumentation is available and Proper analytic instrumentation is available and

trained personnel to perform the tests. trained personnel to perform the tests.

Recovery studies on the product and on placebo Recovery studies on the product and on placebo

samples should be carried.samples should be carried.

If each item of plant is represented symbolically in a If each item of plant is represented symbolically in a

diagram, the arrangement can be reduced to a simple diagram, the arrangement can be reduced to a simple

flow sheet.flow sheet.

Flow sheets are simplified diagrams representing the Flow sheets are simplified diagrams representing the

summary of the operations involved in the summary of the operations involved in the

manufacturing processes in a number of stages with manufacturing processes in a number of stages with

particular pieces of equipment.particular pieces of equipment.

Material entering or leaving the process, or moving Material entering or leaving the process, or moving

from stage to stage, is indicated by arrows.from stage to stage, is indicated by arrows.

Flow sheet: Purification of a substance by Flow sheet: Purification of a substance by

crystallizationcrystallization with manufacturing Processeswith manufacturing Processes

(1)(1) Storage hopperStorage hopper

(2)(2) Solvent feedSolvent feed

(3)(3) Mixing vessel Mixing vessel (Mixing)(Mixing)

(4)(4) Filter pressFilter press (Filtration)(Filtration)

(5)(5) EvaporatorEvaporator (Evaporation)(Evaporation)

(6)(6) CentrifugeCentrifuge (Centrifugation)(Centrifugation)

Flow sheet: Manufacture of a mixed powderFlow sheet: Manufacture of a mixed powder

with manufacturing Processeswith manufacturing Processes

(1)(1) Storage hoppersStorage hoppers

(2)(2) Ball millBall mill (Size Reduction)(Size Reduction)

(3) Sifter(3) Sifter (Size Reduction)(Size Reduction)

(4) Powder mixer(4) Powder mixer (Mixing)(Mixing)

Flow sheet: Manufacture of compressed tablets Flow sheet: Manufacture of compressed tablets

with manufacturing Processeswith manufacturing Processes

(1) Storage hoppers (1) Storage hoppers

(2) Granulating liquid storage tank(2) Granulating liquid storage tank

(3) Mixer(3) Mixer (Mixing)(Mixing)

(4) Granulator(4) Granulator (Size Reduction)(Size Reduction)

(5) fluidized bed dryer(5) fluidized bed dryer (Drying)(Drying)

(6) Sifter(6) Sifter (Size Separation)(Size Separation)

(7) Mixer(7) Mixer (Mixing)(Mixing)

(8) Storage hopper (8) Storage hopper

(9) tablet machine(9) tablet machine

Flow sheet: Manufacture of a dry extract Flow sheet: Manufacture of a dry extract

with manufacturing Processes.with manufacturing Processes.

(1)(1) drug storage hopperdrug storage hopper

(2)(2) water supplywater supply

(3) ethanol storage tank (3) ethanol storage tank

(4) circulating mixer(4) circulating mixer (Mixing)(Mixing)

(5) crushing mill(5) crushing mill (Size Reduction)(Size Reduction)

(6) extraction vessel(6) extraction vessel (Extraction)(Extraction)

(7) extractive storage tank(7) extractive storage tank

(8) exhausted drug discharge(8) exhausted drug discharge

(9) steam supply (9) steam supply

(10) Evaporator(10) Evaporator (Evaporation)(Evaporation)

(11) vacuum oven(11) vacuum oven (Drying)(Drying)

(12) Sifter(12) Sifter (Size Separation)(Size Separation)

(13) fractionating column(13) fractionating column (Distillation)(Distillation)