What is it?

How is it carried out?

Good Manufacturing Practices

The Early Beginnings1900’s house-calls

Home remedies, ointments and miracle elixirs

Entertainment and music

No regulations until 1902

Food and Drug Administration Assures Safety in Drugs it ApprovesHistory of control of drugs, food, cosmetics sold to

the public:

1905- The Jungle by Upton Sinclair - Meatpacking industry led to the Food and Drug Act against unsanitary

conditions

1937-Sulfanilamide caused death in children Control over the purity and effectiveness led to

Federal Food, Drug and Cosmetic Act (1938)

1941 -Carry out clinical trials to determine the efficacy and

toxicity (Insulin)

1962 -Thalidamide tragedy leads to testing of drugs for side effects

A Time Line of GMP continued1963 Establishment of GMP’s for Drug and

Production1966- 1968 Packaging is accurate/Drug Manufacturing Sanitary and Drug is effective1978 cGMP’s for Drugs and Devices

established1979 GLP’s final rules written1988 Food and Drug Administration is

formed and has an appointed commissioner

Premises & EquipmentThe premises and equipment must be

located, designed, constructed, validated and maintained to support the intended operations

Lay out, design and operation must be designed so as to minimize the risk of errors and permit effective cleaning

Adequate and safe provision of lighting, heating ventilation, power, gases, water and drainage.

Premises and Equipment-GMPThere should be defined storage areas

for quarantine, released, rejected and recalled materials.

Where specific storage conditions are required these should be provided, checked and monitored for compliance.

Storage areas should be secure, restricted to authorised person access.

Premises and Equipment- GMPAdequately specified prior to

purchaseValidated correctly before being put

into use and when in useAll equipment must have a serial

numberAll equipment should be calibrated,

cleaned and maintained according to written instructions

Documentation - Why?

1.Clarity of procedures __ Standard Operating Procedures Approved :QualityAssurance2.Confirmation that correct procedures are followed

__ Reviewed by Quality Assurance supervisors, personnel

3.Allows for corrective measures to determine best to use __ Reviewed by Quality Control Management and Production

Documentation Included - GMPKeep procedures, instructions,

specifications, records.Write in a clear concise and

unambiguous way.Review regularly and controlled.Records are kept in inkAlterations to a record should be

signed and dated but must be signed by an authorised person.

Production/Procedures - GMPMust follow clearly defined

procedures and be performed by trained and competent staff

Significant amendments or changes to the production process that may affect the quality of the product or reproducibility of the process should be validated.

Good Manufacturing Practices

Audits TrainingInternal Audits by QA,

QC and Production will External Audits carried

out by the Food and Drug

AdministrationFDA can issue a

warning, and eventually stop production

Records showing consistent review of training of staff

Training includes New personnelChange in

regulationsChange in process

Change ControlWritten procedures should be in place

to describe actions

All changes and/or deviations that affect product quality

Reproducibility of the process should beformally requested documented and accepted.

Production/Procedures - GMPValidation studies should show that the

process, equipment