21 CFR 11 Sec.211.84 sec (c) 4

Hallo Friends/ GMP Experts.

During my audits in different pharma industry it was observed that many companies sample the raw materials from Top,Middle and Bottom layers and they composite the mix while in 21 CFR 11 Sec.211.84 (c) 4 its If it is necessary to sample a component from the top, middle, and bottom of its container, such sample subdivisions shall not be composited for testing.

This leads for Non Compliance for 211.84 (c) 4 and leads for arguments with the companies. I would like to know your opinions about this.

Thank you everyone for your time and reply.

Nitin R Parab
Independent Lead Auditor for UL



Sampling (should comply with ISO statistics) has been demonstrated to be acceptable during ‘process validation’. Acceptance criteria should be the same as your specifications.

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