Hello. We are the manufacturer of a combined device. We currently test the incoming API yearly. It is unclear where this requirement came from. ICH Q7 appears to apply to the manufacturer only to which they comply. I propose to move to testing as per the suppliers recommended retest date as per their COA. Does anyone know of any requirements or guidelines for this situation?
Many thanks
According to the ICH Guideline Q7(term 11.54), at least one batch per year should be added to the stability program and tested at least annually to confirm the stability. If the validity period is more than 2 years, it can be tested on a yearly basis such as 0, 12, 24, 36 months.
This is the responsibility of the API manufacturer, and the buyer uses the API as a raw material, so it could be handled in accordance with the buyer's internal rules of raw material management.
Dear Mary Donnellan,
Principally all manufacturers must guarantee the totality of quality of their products (API, intermediates or finished products) by the end of expiration (or validity) date according to the stability studies.
On the other hand, all buyers must control periodically their raw materials even if they meet and consider all environmental storage conditions (temperature, humidity, light and so on) of raw materials according to the manufacturers’ recommendations.
Please read the following references as attached files:
1. The IPEC Excipient Stability Program Guide
2. Health Products and Food Branch Inspectorate Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (APIs)
I hope this information will be useful to you.
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