Drug Evaluation Committee 2017-71 Record of Review of Standard Operating Procedures
Related classification: SOPs
Date of first publication: February 2018
Question
During an audit by the sponsor of a clinical trial, the following advice was given for the future: "Regarding the annual review of standard operating procedures (SOPs), I think it would be better to create a record of the implementation of the review even if there are no revisions." The auditor pointed out that the SOPs should be reviewed annually, even if there are no revisions. Naturally, the relevant SOPs have been implemented without the phrase, "A record of the implementation of the review shall be prepared even if there are no revisions. What on earth is the problem?
For example, GCP should be revised as necessary, but in a year when there is no revision, is a "record of the implementation of the review in the absence of revision" being prepared? We believe that SOPs should be revised from time to time as necessary. We do not think it is necessary to prepare a record of review when there is no need for revision.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Standard Operating Procedures (SOPs) specify standard procedures according to each organization's situation (organizational structure, personnel, other regulations of the organization, etc.) to ensure that clinical trials are properly conducted in compliance with GCP, and are one of the important elements to establish a quality management system (GCP Article 4.1 Guidance 1, 2 and Article (See Guidance 1, 2 in Article 4, Paragraph 1 and Article 36, Paragraph 1/Section 2 of the GCP).
The operational procedures specified in SOPs must always be appropriate for proper conduct of clinical trials, and must be revised in response to changes in organizational, regulatory, or other circumstances. To ensure this, we believe it is effective to stipulate in the SOPs that the contents should be reviewed after a certain period of time has elapsed since the SOPs were issued and to implement the review.
In order to ensure that this process of reviewing SOPs has been properly implemented, we believe that it is necessary to create and preserve records of the review of whether or not revisions are necessary.