Drug regulation is strictly regulated in the United States. Title 21 Code of Federal Regulations (CFR) Parts 210 and 211 contain the minimum Current Good Manufacturing Practices (cGMP) regulations for drug manufacturing processing and packaging according to the Food and Drug Administration (FDA). These regulations are the Rule Book for pharmaceutical companies and they tell the drug companies what they have to do, but not necessarily how to do them.
Written Procedures for Production
Among all these regulations, drug companies must have written procedures for production and process controls to ensure drug products have specified identity, strength, quality and purity. Part 211.100 states that these procedures have to be ensured by the drug companies quality assurance and quality control departments. These written procedures must be followed and the process control functions must be recorded at time of completion. Any deviations from these procedures must be recorded and justified.
Labeled Containers
Containers must be be labeled with name, item code, control number, batch for which component was issued, including name, weight or measurement in new container, strength and and lot number and not less than 100% of the labeled or established amount of active ingredient according to Part 211.101.
Verification of Quality Control Procedures
The quality control process is very strict in that any and all procedures must be verified by a second person. The procedures for a development of a drug as simple as an over-the-counter aspirin could take as many as 14,000 signatures.
Finished Operations Examination
According to 211.134, packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label and a representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.
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