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Amongst other things as a pharmacovigilance consultant, I do a lot of audits and mock inspections in the FDA and EMA/EU styles.  A surprisingly consistent finding that I note is a frequent lack of understanding of what is expected from companies regarding standard operating procedures (SOPs), Work Instructions (WIs), Manuals, Guidelines, “Cheat Sheets” and other documents prepared for staff explaining precisely what their responsibilities are and how they are to do their tasks.

All of these documents can be lumped together and are called “procedural documents” and all should be versioned, controlled documents.  In this posting, I’m using “SOP” and “procedural documents” more or less synonymously.

The obvious first question is: do companies really need SOPs? The answer is a clear yes.  Written SOPs are mandatory in Quality Management Systems.

EMA: Good PV Guidelines Module 1 PV & Quality Systems page 10 (https://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129132.pdf) :

“All elements, requirements and provisions adopted for the quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records [IR Art 8(4)].”

FDA: 21CFR314.80(b) and 310.305(c)(5):

“Any person subject to the reporting requirements under paragraph (c) of this section shall also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA.”

Several audit findings are so prevalent that they bear mentioning:

If an inspector finds an older, out-of-date version being used by the staff (or, worse, some of the staff but not all) there will be a citation.

If you think this is too bureaucratic and not that important, think about it the next time you get on an airplane.  I’m sure you want the pilot to be using the latest SOP and “how to fly the plane” manual!

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