This is a controlled form. It records the review and approval of a new or revised SOP so the decision is traceable to a specific version, the reviewers and their findings are documented, and the effective date is tied to training completion. Replace each <<FILL: ...>> placeholder, route it with the SOP through your document control system, and retain it with the change control record. A worked filled specimen follows. This form is the evidence that 21 CFR 211.100(b) and your own document control SOP were satisfied, not a substitute for them.
1. SOP under review
2. Review summary
Each reviewer records the scope of their review, whether they found defects, and confirms their findings were resolved before they signed. A reviewer who found defects does not sign as approved until the resolution is verified.
3. Findings and resolution log
All findings of critical or major severity must be resolved and verified before approval. The disposition of any deferred minor finding must be stated with a reason.
4. Pre-approval confirmations
The author and QA confirm each of the following is true before signatures are applied. Any “No” blocks approval.
5. Training and effective date alignment
A new or revised SOP cannot take effect before the people who must follow it are trained on it.
If the effective date is set before training can complete, the form is returned; there must be no window where the SOP is in force but staff are untrained.
6. Approval signatures
Signatures certify that the named version of the SOP has been reviewed, all critical and major findings are resolved, and the document is fit to be issued. Signatures must be traceable to the version above, wet ink or compliant electronic signature.
7. Document control use only
References
21 CFR 211.100(b) (written procedures shall be followed and documented at the time of performance).
21 CFR 211.22(d) (the quality unit’s procedures shall be in writing) and 211.25 (training).
21 CFR Part 11 (electronic records and electronic signatures), where signatures are electronic.
EU GMP (EudraLex Volume 4) Chapter 4, Documentation, and Annex 11 where applicable.
ICH Q10, Pharmaceutical Quality System.
Confirm the current version and clause numbers of each reference before use.
Filled specimen
The following shows the form completed for an example revision, version 2.0 of a procedure for receiving and quarantining incoming raw material samples. The company, IDs, names, and dates are illustrative; replace them with your own.
Header and SOP under review (specimen)
Review summary (specimen)
Findings and resolution log (specimen)
Training and effective date (specimen)
In this specimen both major findings were resolved and verified before any signature was applied, the form was brought under control before approval, and the effective date was set one day after training completion. The record shows an inspector exactly who reviewed what, what they found, how it was fixed, and that no one followed the revised SOP before being trained.
- An approved SOP with no record of who reviewed it or what they checked.
- A revision in use before its approval, or staff following an unapproved draft.
- An SOP effective before the affected staff were trained on it.
- Approval signatures that cannot be tied to the specific version that was issued.
- Findings raised in review that were never shown to be resolved before sign-off.
- A revision with no traceable change reason, so the prior requirement cannot be reconstructed.
- Referenced forms that were still uncontrolled at the moment of approval.
- Set the form number and version to match your document control numbering, and link it to your SOP-of-SOPs.
- Adjust the review types in section 2 to your defined roles; keep the usability dry run as a distinct, recorded review.
- Define your severity scale in section 3 and which severities block approval in your system.
- Keep section 5 (training and effective date alignment) mandatory; the training-to-effective-date window is a frequent finding.
- Attach this completed form and the reviewer comment log to the change control record so the approval evidence travels with the SOP.
- Confirm every cited regulation against its current published version before relying on this form.
