How do you ensure that SOPs are followed?

Quality and consistency result from correctly following established SOPs. GMP Audits are performed to verify that SOPs are correctly and consistently followed. An SOP tells who does what, when, and where. An instruction tells how. They may be all on one document or separate documents.

To verify that the SOP is being followed, the GMP Auditor must ask these questions:

• Who is supposed to do it?

• What are they supposed to do?

• When are they supposed to do it?

• Where are they supposed to do it?

• How are they supposed to do it?

Written documentation describing a process that does not answer all five of these questions is incomplete. A GMP Auditor would make note of this in the GMP Audit report. The GMP Audit report would say, “documentation requires further development” or similar words to that effect. One would question how effective the written procedure could be if it never tells when or where it applies.