What is in section 211.142 - Warehousing procedures
Written procedures
Quarantine of drug products before release
Appropriate storage condition for temperature, humidity and light
What is in 211.150 Distribution procedures?
Written procedures. First in First out. Distribution system should facilitate recalls if necessary
What is in section 211.160 General requirements for Laboratory controls?
Any specifications, standards, sampling plans and test procedures shall be reviewed and approved by QCU
Requirements shall be followed and documented at time of performance
Conformance to appropriate written specifications for processes
What is in section 211.165 Testing and release for distribution?
Lab determination of satisfactory conformance to final specifications prior to release
Each batch must be free of contaminants
Method of sampling and number of units in each batch
Validation and documentation
Criteria for reprocessed material
What is in section 211.166 Stability testing?
Sample size and test intervals
Storage conditions
Specific test methods
Testing of drug in container-closure system
Testing of drug products before and after reconstitution
Accelerated studies to provide tentative expiration dates
What is the purpose of stability tests?
To predict and confirm product shelf life under climatic conditions expected during trade.
What are the 3 types of stability tests?
- Studies under accelerated conditions to predict tentative shelf life for new product, under stress and interactive effects
- Studies under conditions appropriate to market, to provide real time data for confirmation of shelf life
- Studies on current production to evaluate ongoing batches
What is in section 211.170 Reserve samples?
Reserve samples are representation of each lot. Retained for 1 year after expiration date of last lot, or for OTC products, 3 years after distribution of last lost
What is in section 211.173 Laboratory animals?
Animals used for testing are maintained and controlled in a manner that assures suitability
They are identified, and records to show history of their use
What is in section 211.176 Penicillin contamination?
If there is a possibility that a drug has been contaminated with penicillin, it shall be tested for the presence of penicillin
If penicillin is detected, the drug will not be marketed
What is in section 211.204 Returned drug products?
Returned drug products identified and held
Can be reprocessed to meet standards
Written procedures for holding, testing and reprocessing
What is in section 211.208 Drug product salvaging?
Drug that has been in improper storage conditions shall not be salvaged and returned to the marketplace
What is required of report writing?
Factual, avoid writing in first person, and give as many related references as possible
What is required in change controls?
