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By

Virendra singh

M.pharm(1stsem)

[email protected]

Department of Pharmaceutics

Roorkee college of Pharmacy

Roorkee

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Definition That part of QA which ensures that products are

consistently produced and controlled to the quality

standards as per the specifications.

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The Early Beginnings 1900s- house-calls

Home remedies, ointments and miracle elixirs

No regulations until 1902

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Public Involvement1905- TheJungle by

Upton Sinclair

Exposure of unsanitary

Meat packing plants.

Increased Public awareness

And involvement Pure Food and Drug Act

False labeling became illegal

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A Time line of GMP 1902 - Development of the Biologic Control Act 1906 - Development of the Pure Food and Drug Act 1938 - Federal Food, Drug and Cosmetic Act

1941 - Initiation of GMP 1944 - Development of Public Health Services Act 1962 - Kefauver-Harris Drug Amendments released 1963 - Establishment of GMPs for Drugs 1975 - CGMPs for Blood and Components Final Rule

1976 - Medical Device Amendments 1978 - cGMPs for Drugs and Medical Devices 1979 - GLPs Final Rule 1980 - Infant Formula Act is passed

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1941 Initiation of GMP Sulfathiaziole tablets contaminated with phenobarbital

1941 - 300 people died/injured

FDA to enforce and revise manufacturing and quality

control requirements 1941 - GMP is born

Thalidomide tragedy

Thousands of children born with birth defects due toadverse drug reactions of morning sickness pill taken by

mothers Strengthen FDAs regulations regarding experimentation

on humans and proposed new way how drugs areapproved and regulated

Proof of efficacy law

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Guidelines

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Areas to be Covered

General considerations

Personnel

Premises

Equipment

Sanitation

SOPs

Raw Materials

Self Inspection And Audit

Master Formula Records

Batch Manufacturing Records

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Areas to be Covered(cont..) Warehousing Area

Reference Samples

Validation and process validation

Labels And Other Printed Materials

QA

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General considerations Compliance with GMP

Consistent uniform batches

Location And surroundings

Water system

Disposal Of Waste

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PERSONNEL

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PERSONNEL Qualified Personnel

a)Experienced

b)Sufficient Number

Written job description

Trained

Health

a)Diseases

b)Open Lesions

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Premises

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PremisesPoints to be Consider

Location Design

Construction

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PremisesLocation

Geography, climate,and economic factors

Neighboursa)What do they do?

Premises must be located to minimize risks of cross-contamination,

e.g. notlocated next to a malting factory with high airborne levels of

yeast

Pollution/effluent control

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PremisesLocation(cont..)

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PremisesDesign

Minimize risks of errors

Permit effective cleaning Permit effective maintenance

Avoid cross-contamination, build-up of dirt and dust

Maximum protection against entry of insects, birds

and animals

Separate facilities for other products such as some

antibiotics, hormones, cytotoxic substances

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PremisesDesign(cont..)

Maximum protection against entry of insects, birds and animals

Specific Areas

1) Production areas2) Quality control areas

3) Weighing areas

4) Storage areas

5) Ancillary areas

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Premises Hygiene

Eating,Drinking,Smoking Should not be allowed in

the Production area.

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PremisesConstruction

Measures should be taken to prevent cross-

contamination

Dust control measures (including extraction of dust

and air)

No areas for dust accumulation

Easily cleanable surfaces Proper air supply

Use of HEPA filters

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Premises Finishing floors,walls,and Ceilings

Should be smooth, impervious, hard-wearing, easyto clean

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Equipments

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Equipments Equipment shall be

located,designed,construcetd,adapted and

maintained to suit the operation to be carried out.

Should be made of non reactive material,such as

High grade of steel(316,302)

Equipment should be-

a) Caliberatedb)Checked

c)labelled

d)Sterilized

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Sanitation Written procedures

hygiene, health and clothing practices

waste disposal

Implementation and training

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Sanitation Practices not permitted

a)eating, smoking

b)unhygienic practices

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Standard Operating

Procedure

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Standard Operating

Procedure There shall be written Standard Operating Procedure

for each operation

It include-a)For Eqipments

b)For sampling

c)For Testingd)For Process

f)For Packaging

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Raw Materials

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Raw Materials

An Inventory should be maintained for Raw

materials to be used at any stage of manufacture

Records should be maintain as per Schedule U

Should be purchased from approved sources

Must be checked by QC department on recipt

Should be labeled.

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Self Inspection And Audit

Regular independent inspection is necessary to

evaluate the manufacturers compliance with GMP in

all aspects of manufacturing

Procedure for self inspection shall be documented

indicating

a)Evaluation

b)Conclusion c)Recommendations for Corrective action

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Master Formula Records

There shall be MFR relating to all manufacturingprocedures for each product and batch size to bemanufacture

It should include-i)The name of the productii)Quantity,of all starting materials to be used

iii)A statement of the expected final yield withacceptable limits.

iv) Principal equipment to be usedv) Detaild stepwise processing instructions and the timetaken for each step

vi)Any special precations

vii)Packing details and Specimen labels

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Batch Manufacturing

Records There shall be Batch processing record for each

product.

During Manufacturing or Processing the followinginformation shall be recorded

It include-

The name of the product

The number of Batch being manufacturedDates and time of commencement of batch and

completion

Initials of operator

Amount of Product obtained

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Warehousing Area

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Warehousing Area

Warehousing area should be designed and adaptedto ensure good storage conditions.

Should be Clean,dry and maintained with acceptabletemperature limits.

Should have appropriate house-keeping androdents,pests and vermin control.

Seprate sampling area for active raw material andexcipients.

Every Material stored should be labeld properly.

Fire Prevention

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Reference Samples

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Reference Samples

Should be taken in sufficient quantity from each lot of

active ingridient to carry out all the tests

These samples should be retained for a period of 3

months after the date of expiry of the last batch

produced from that active ingridient

Samples of raw material should be stored in suitable

container(plastic or glass) as mentioned in the SOP

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Reference Samples

Samples of finished formulations shall be stored in

the same containers in which the drug has been

actually marketed

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Reference Samples

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Validation and process

validation Essential part of GMP

Necessary to achieve the intended results

A written record is prepared summarizing recorded result and

conclusions shall be prepared ,documented and maintained

Should be necessary when-

a)Any new new master formula or method of

prepration is adopted

b)For critical processc)any changes in the equipment,or when

using a new equipment,it is first validated

to demonstrate its consistentency of

required quality

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Labels And Other Printed

Materials

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MaterialsAll containers and equipment should bear labels

Different colour coded labels should be used to

indicate the status of a product(for example undertest,approved,passed,rejected)

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Materials(cont..) The Printing should be done in bright colours

The label should contain all the prescribed details

about the product.

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Quality Assurance

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Quality Assurance The main objective of the quality assurance is to

ensure the products are of the quality required fortheir intended use

Functions- i)Adequates are made for manufacuring,supply and

the use of correct starting and packing material

ii)Adequate control on startingmaterial,intermediate,and bulk products.

Iii)Process validation in accordance with establishedprocedures

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References Blackwell, John. 1906: Rumble Over The Jungle. 31 Aug. 2008.http://www.capitalcentury.com/1906.html

FDA Food and Drug Administration. GMP Combination Handbooks. 31

Aug. 2008. http://images.google.com

WHO Technical Report Series, No. 929, 2005
http://www.capitalcentury.com/1906.htmlhttp://www.capitalcentury.com/1906.htmlhttp://www.capitalcentury.com/1906.htmlhttp://www.capitalcentury.com/1906.html

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Documents

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