GMP inspection findings – Pharma GMP

Why Backdated Entries Trigger Data Integrity Violations

digi — Wed, 10 Sep 2025 17:59:13 +0000

Why Backdated Entries Trigger Data Integrity Violations Backdated Entries and Their Impact on GMP Data Integrity Introduction: Why This Topic Matters for GMP Compliance In pharmaceutical manufacturing, accuracy and integrity of records are paramount. Every entry in a logbook, batch record, or laboratory notebook serves as proof that GMP processes were executed as required. Backdating...

How to Handle Missing Batch Records During a GMP Audit

digi — Wed, 10 Sep 2025 08:43:22 +0000

How to Handle Missing Batch Records During a GMP Audit Managing Missing Batch Records During GMP Audits Introduction: Why This Topic Matters for GMP Compliance Batch records are one of the most critical documents in pharmaceutical manufacturing. They serve as the evidence that every step in the production, packaging, and testing process was executed according...

Common GMP Documentation Failures Found in FDA 483s

digi — Wed, 10 Sep 2025 01:25:22 +0000

Common GMP Documentation Failures Found in FDA 483s Most Frequent GMP Documentation Failures in FDA 483s Introduction: Why This Topic Matters for GMP Compliance Documentation forms the backbone of Good Manufacturing Practice (GMP) compliance. Regulatory agencies, especially the U.S. Food and Drug Administration (FDA), repeatedly stress that if an activity is not documented, it is...

What to Do After Receiving a WHO GMP Audit Observation

digi — Tue, 09 Sep 2025 07:49:52 +0000

What to Do After Receiving a WHO GMP Audit Observation Responding Effectively to WHO GMP Audit Observations Introduction: Why This Topic Matters for GMP Compliance The World Health Organization (WHO) conducts Good Manufacturing Practice (GMP) audits, particularly for companies supplying medicines to international procurement programs such as UNICEF, UNFPA, and the Global Fund. When deficiencies...

Difference Between WHO GMP, cGMP, and EU GMP

digi — Wed, 03 Sep 2025 21:59:04 +0000

Difference Between WHO GMP, cGMP, and EU GMP Comparing WHO GMP, cGMP, and EU GMP: Key Differences and Compliance Requirements Introduction: Why This Topic Matters for GMP Compliance Pharmaceutical manufacturers operate in a highly regulated global market. To supply medicines internationally, companies must demonstrate compliance with Good Manufacturing Practices (GMP) as defined by various regulatory...

Harmonized GMP Audit Reports: Format, Content, and Cross-Agency Acceptance

digi — Thu, 22 May 2025 09:20:25 +0000

Harmonized GMP Audit Reports: Format, Content, and Cross-Agency Acceptance Harmonized GMP Audit Reports: Global Templates, Core Elements, and Regulatory Acceptance Good Manufacturing Practice (GMP) audit reports are essential records of regulatory inspections that document compliance status, identify deficiencies, and guide post-inspection actions. As pharmaceutical oversight becomes increasingly globalized, the push for harmonized GMP audit reports...