ALCOA+ principles pharma – Pharma GMP

SOP Template: How to Handle Record Corrections Legally

digi — Fri, 14 Nov 2025 10:42:26 +0000

SOP Template: How to Handle Record Corrections Legally SOP Template for Handling GMP Record Corrections Legally Introduction: Why This Topic Matters for GMP Compliance Record corrections are a normal part of pharmaceutical documentation, but if not handled properly, they can raise concerns about data integrity and falsification. Regulators such as FDA, EMA, and WHO explicitly...

FDA Expectations for Chronological Integrity in GMP Entries

digi — Mon, 15 Sep 2025 02:29:54 +0000

FDA Expectations for Chronological Integrity in GMP Entries FDA Expectations for Chronological Integrity in GMP Documentation Introduction: Why This Topic Matters for GMP Compliance Chronological integrity is a fundamental requirement of Good Manufacturing Practice (GMP) documentation. It ensures that entries in batch records, logbooks, and laboratory notebooks reflect the actual sequence of events, creating a...

GMP Rule: Why You Should Never Use Correction Fluid

digi — Fri, 12 Sep 2025 10:16:24 +0000

GMP Rule: Why You Should Never Use Correction Fluid Why Correction Fluid Is Strictly Prohibited in GMP Documentation Introduction: Why This Topic Matters for GMP Compliance In pharmaceutical manufacturing, documentation serves as the legal and scientific record of activities performed. Regulators such as the FDA, EMA, and WHO consistently emphasize that records must be complete,...