laboratory compliance – Pharma GMP

Don’t Discard Unused Reagents Without Updating the Inventory Logs

digi — Sun, 28 Sep 2025 22:16:39 +0000

Don’t Discard Unused Reagents Without Updating the Inventory Logs Never Discard Unused Reagents Without Updating the Inventory Records Remember: Always update reagent inventory logs before discarding unused chemicals — it ensures traceability and supports GMP accountability. Why This Matters in GMP Laboratory reagents are classified as controlled materials in GMP settings. Their procurement, usage, and...

Review Analyst Qualifications Annually to Maintain GMP Standards

digi — Tue, 22 Jul 2025 11:51:03 +0000

Review Analyst Qualifications Annually to Maintain GMP Standards Review Lab Analyst Qualifications Annually to Maintain GMP Integrity Remember: GMP mandates that qualifications of lab analysts be reviewed annually to ensure current competence and compliance with updated methods and systems. Why This Matters in GMP Qualified laboratory analysts are responsible for performing critical tasks including raw...

Document All OOS Investigations Within Prescribed GMP Timelines

digi — Mon, 14 Jul 2025 16:26:07 +0000

Document All OOS Investigations Within Prescribed GMP Timelines Ensure OOS Investigations Are Documented Within GMP Timelines Remember: All Out-of-Specification (OOS) results must be documented and investigated within defined timelines to maintain data integrity and GMP compliance. Why This Matters in GMP Out-of-Specification (OOS) results signal that a product may not meet quality standards, and prompt...