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

The Early Beginnings 1900’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 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

A Time Line of GMP continued 1963 Establishment of GMP’s for Drug and Production 1966- 1968 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

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.

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.

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

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

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.

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.

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

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.

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