WHO GMP audit observations – Pharma GMP

How to Establish a Documentation Control SOP

digi — Sun, 14 Sep 2025 18:09:06 +0000

How to Establish a Documentation Control SOP Creating a Robust Documentation Control SOP for GMP Compliance Introduction: Why This Topic Matters for GMP Compliance In a pharmaceutical environment, documents such as SOPs, batch records, logbooks, and protocols form the backbone of GMP compliance. Without strong control systems, outdated, unauthorized, or incomplete documents can be used...

WHO Inspection Follow-Up: CAPA and Compliance Monitoring

digi — Thu, 29 May 2025 11:13:27 +0000

WHO Inspection Follow-Up: CAPA and Compliance Monitoring WHO Inspection Follow-Up: Managing CAPA and Ensuring GMP Compliance The conclusion of a WHO GMP inspection does not mark the end of the evaluation process—it signals the beginning of a critical compliance phase. Pharmaceutical manufacturers must respond to observations through structured Corrective and Preventive Action (CAPA) plans and...