The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Reviewing SOP Execution Logs Before Regulatory Audits How to Review SOP Execution Logs for Audit Readiness Standard Operating Procedures (SOPs) are the backbone of compliance in pharmaceutical manufacturing, but regulators don’t just check if SOPs exist—they inspect how well they are followed. One of the most scrutinized records during audits are SOP execution logs. These…
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Addressing Oversight Failures in Third-Party SOP Compliance Improving Oversight of Third-Party SOP Compliance in GMP Operations Introduction to the Audit Finding 1. What the Issue Involves This audit finding pertains to inadequate internal oversight of Standard Operating Procedures (SOPs) at third-party sites such as contract manufacturers (CMOs), laboratories, or packagers. 2. GMP Accountability Still Rests…
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GMP Audit Finding: SOPs Revised Without Version History Why Missing Version History in SOP Revisions Compromises GMP Control Introduction to the Audit Finding 1. Lack of Change Traceability When SOPs are revised without maintaining version history, it becomes impossible to track what was changed, when, and by whom. 2. Data Integrity Violation Version control ensures…
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