We made a checklist of every suggestion of a requirement in 21 CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF
HEALTH AND HUMAN
PART 820--QUALITY SYSTEM REGULATION
It includes 752 questions directly related to what appear to be requirements of the standard. The complete audit is available in MS Word format (.doc) and can be purchased online through the following Paypal link.
If you prefer, you can order directly:
15949 Greenhow Point Road
Brainerd, MN 56401
DISCLAIMER: Use of this audit checklist does not guarantee compliance with FDA requirements.
This document contains an audit checklist based upon the “shalls” indicated in 21 CFR 820, Quality System Regulations, of Title 21, Food and Drugs, Chapter I, Food and Drug Administration, Department of Health and Human Services.
21CFR820 “Shalls” Audit Checklist
There are specific requirements or “shalls” in 21 CFR 820. A checklist that accounts for all the apparent “shalls” should be a relatively complete audit of the system. This will not verify that you are in complete compliance with the standard, however, but it will confirm that you have considered all the requirements. In addition to documents, review of the records and interviews with personnel will reveal whether the people know there is a system, are aware of and actually do the requirements, and whether it is effectively implemented and maintained.
The audit checklist starts with Sec 820.5, Quality System (page 141).
In responding to a particular question, though “yes” may be the correct response, it is better to indicate how, where, what, why, and who makes the answer “yes”. For example: specific documents, paragraphs; or specific records; maybe even personal responsibilities. You may know that “yes” is correct. Can you prove it with hard, objective evidence other than your opinion? This usually means a piece of paper or at least a computer screen.
Copyright © 2002, WJC Designs
-- End of Document --