Which SOPs are required by GMP?


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While this provides an insight into a possible(minimum) ways to meet the regulations (part 211); the performance really depends on the meeting the intent of each of the procedures; and maintaining the measurable performance / improvements; viz.,
* audit observations have gradually shifted(/graduated) from lack of systems to --> effectiveness of systems (implementation of them or incident reporting, CAPA, RCA, etc)
* common reasons for recalls also indicate the lack of reliability of those minimum systems (labelling, mixups, stability failures etc)

* and then emphasis on the 'data integrity'; both from guidance & audit observations pertaining to part 11 compliance.

the point is, we need to start focussing from availability(completeness) of systems --> to --> effectiveness of same; which is absolutely missing in the pharma quality sector.!
Last edited:

Ronen E

Problem Solver
I understood the opening post as an expression of an opinion. I generally agree but I'm not ideally positioned to comment on GMP/QMS existence vs. effectiveness in the pharma industry.
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