1. Good Manufacturing Practices
What is it?
How is it carried out?

2. The Early Beginnings 1900’s house-calls
Home remedies, ointments and miracle elixirs
Entertainment and music
No regulations until 1902

3. Food and Drug Administration Assures Safety in Drugs it Approves
History 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

4. A Time Line of GMP continued
1963 Establishment of GMP’s for Drug and Production Packaging is accurate/Drug Manufacturing Sanitary and Drug is effective 1978 cGMP’s for Drugs and Devices established 1979 GLP’s final rules written 1988 Food and Drug Administration is formed and has an appointed commissioner

5. Premises & Equipment
The 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.

6. Premises and Equipment-GMP
There 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.

7. Premises and Equipment- GMP
Adequately specified prior to purchase
Validated correctly before being put into use and when in use
All equipment must have a serial number
All equipment should be calibrated, cleaned and maintained according to written instructions

8. Documentation - Why?
1.Clarity of procedures __ Standard Operating Procedures
Approved :QualityAssurance
2.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

9. Documentation Included - GMP
Keep procedures, instructions, specifications, records.
Write in a clear concise and unambiguous way.
Review regularly and controlled.
Records are kept in ink
Alterations to a record should be signed and dated but must be signed by an authorised person.

10. Production/Procedures - GMP
Must 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.

11. Good Manufacturing Practices
Audits
Training
Internal Audits by QA, QC and Production will
External Audits carried out
by the Food and Drug Administration
FDA can issue a warning, and eventually stop production
Records showing consistent review of training of staff
Training includes
New personnel
Change in regulations
Change in process

12. Change Control
Written procedures should be in place to describe actions
All changes and/or deviations that affect product quality
Reproducibility of the process should be
formally requested documented and accepted.

13. Production/Procedures - GMP
Validation studies should show that the process, equipment