Drug Evaluation Committee 2008-30 Version Control of the SOPs (Part 1)
Related classification: Other
First published: January 2009
Question
We would like to revise the SOPs of a medical institution. The current SOPs are divided into separate volumes for each item, and we are considering revising them to make them a single volume. However, the number of editions is assigned to each book, so there is a 2nd edition, a 10th edition, etc. In this case, we would like to revise the SOP into a single book. In this case, please let me know how we should do the edition number when we revise it to one volume.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
There is no rule in GCP regarding the number of editions of procedure manuals (SOPs). It is fine to number the SOPs in accordance with the procedures for preparing SOPs at the implementing medical institution. In the case of your question, it would be acceptable to record and store the version control of the SOPs that were previously in separate volumes, along with the revision history, and to treat the newly integrated SOP as the first revised version. In this case, we think it is important to record the history of the transition from a separate SOP to an integrated SOP.