i want to know what is the retention period of API Documents …like BPR’S, ATR etc.
Generally, these are stored for 1 year after the expiry of the product or API.
Expiry + 1 year. Then u scanned the documents and preserve at least for 7 years.
BMRs are kept in record for 1 year after the expiry of the product…
In addition to the below Answers, If the manufacturing documents are related to validation or Qualification studies, those shall be maintained for life time. If those are for commercial batches purpose expiry date + 1 year will be applicable.
Product expired +1year ,but in case these are validation batches and submitted to any regulatory then it should be preserved up to the final approval
Expiry plus one year but in case of validation these documents are stored for lifetime.
Expiry plus one year or five year which ever is longer and validation document for life time…
1 Like