Free templatesWord + PDF
Free GMP templates for pharma quality teams.
Practical, editable templates for the records inspectors ask about most — each explained on its own page, so you know what good looks like before you download.
- Editable Word + print-ready PDF
- Explained field by field
- Free — link by email
Seven templates
Start from a proven structure.
-
CAPA form
From problem statement and root cause to actions, extensions and a defined effectiveness check.
CAPA form template -
OOS investigation
Phase I laboratory checklist, pre-approved retest plan and full-scale investigation.
OOS investigation template -
Deviation report
Description, containment, classification, impact assessment, root cause and QA decision.
Deviation report template -
Change control form
Request, nine-area impact assessment, risk, approval before implementation and effectiveness.
Change control template -
21 CFR Part 11 checklist
Twenty-four clause-by-clause checks for electronic records and signatures.
Part 11 checklist -
APQR outline
The thirteen sections of an annual product quality review, with data sources.
APQR template -
Schedule M gap checklist
Thirty requirements to walk area by area, with evidence, gap, owner and date.
Schedule M checklist
FAQ
Frequently asked questions
Can’t find your answer? Talk to our team — we reply within one business day.
Are the templates free to use?
Yes. Download them, adapt them to your procedures and approve them through your own document control before use.
Why do you ask for my email?
We email the download link (valid for 7 days). Your details are emailed to our team and not stored on this website.
Are these templates validated or approved by a regulator?
No. They are practical starting points reflecting common GMP expectations — not regulatory advice. Your QA function remains responsible for the final procedure.
Tired of templates and binders?
In Swat iQua Suite these records are created, linked, signed and audit-trailed electronically. Book a free demo to see how.