The purpose of a retest date is to ensure that the API is still suitable for use. The API manufacturer can extend the retest date of a specific batch based on good science and longterm stability results for that API and testing of the specific batch that has been stored according to the label conditions. In some regions, regulatory authority approval of the retest date extension for the batch may be required. If an API manufacturer wants to change (i.e., extend) the retest date for future batches of an API, then it should conduct stability testing sufficient to support the change, and include the new retest date and supporting data in a regulatory filing, as determined by regional requirements
What is meant by ‘completely distributed’ in [ICH Q7, 11.71 which indicates reserve/retention samples should be retained for 3 years after the batch is completely distributed by the manufacturer?
Completely distributed’ refers to the distribution of the entire batch of the API by the API manufacturer to the next party in the supply chain. It should be noted that this applies to all parties that physically process or repackage the API [ICH Q7, 20 – see Glossary for definition of ‘manufacture’). The intent of ICH Q7 is to retain samples for the period of time that the API could be in the market in order to investigate any problems and/or product complaints. Based on accepted industry practice at the time ICH Q7 was written, it was not anticipated that a manufacturer would set a retest date longer than 3 years. It is a basic GMP principle that reserve samples be retained for the entire period the material is available on the market. For example, if a company sets a retest date of 5 years and the API is completely distributed immediately after manufacturing, it was never intended that the reserve sample be destroyed before the 5 year retest date was reached.
Why does ICH Q7 permit the use of a packaging system for reserve/retention samples that is ‘more protective than the marketed packaging system’ [ICH Q7, 11.72]?
Unlike stability samples, the purpose of the reserve/retention sample is not to represent the quality of the batch in the market place but to allow future evaluation of the quality of the original API batch (e.g., in evaluation of potential counterfeits, etc.). Therefore, reserve/retention samples may be stored in packaging (and conditions) that better preserve the original state of the API.
Is the lifecycle approach to process validation acceptable for APIs under ICH Q7?
Yes, ICH Q7 does not preclude the lifecycle approach [ICH Q7, 12.10, ICH Q10, ICH Q11].
Can the range of a process parameter be expanded based only on a process deviation(s)?
No. However, information from the investigation into a process deviation(s) can be used to support expanding the range of a process parameter. Additional work and studies are normally needed to adequately demonstrate that the expanded range for the process parameter consistently produces API of the necessary quality [ICH Q7, 2.16, 12.11, 13.13].
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