The Ultimate Resource for Pharmaceutical SOPs and Best Practices
In one 483, FDA noted that multiple versions of an SOP on sampling procedures were found on the same shared drive. Operators accessed different versions, leading to non-uniform practices in microbiological sampling.
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Traditional SOP revision methods involve paper-based updates, emails, manual sign-offs, and scattered file storage. These introduce multiple challenges:
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The revision to ICH Q9 on Quality Risk Management emphasized better data-driven decisions and the use of risk-based approaches in routine operations. Companies were expected to revise their SOPs on:
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A robust framework should include:
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The review frequency should be based on document criticality, risk, and regulatory requirements. Common practices include:
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