deviation control – Pharma GMP

Don’t Reassign Lots Without a Verified and Traceable Audit Trail

digi — Tue, 26 Aug 2025 22:13:36 +0000

Don’t Reassign Lots Without a Verified and Traceable Audit Trail Do Not Reassign Product Lots Without Maintaining a Verified Audit Trail Remember: Never change or reassign lot numbers without a fully documented and traceable audit trail authorized by Quality Assurance. Why This Matters in GMP Lot numbers are unique identifiers that allow pharmaceutical companies to...

Conduct Annual Equipment Lifecycle Management Reviews

digi — Sun, 10 Aug 2025 03:52:34 +0000

Conduct Annual Equipment Lifecycle Management Reviews Annual Review of Equipment Lifecycle: A GMP Imperative Remember: Conduct yearly lifecycle management reviews to ensure equipment reliability, GMP compliance, and continuous process improvement. Why This Matters in GMP In a GMP-regulated manufacturing environment, equipment must function consistently within its validated parameters. Over time, equipment degrades due to mechanical...

Never Change Sampling Procedures Mid-Study Without Documented Justification

digi — Thu, 31 Jul 2025 09:55:04 +0000

Never Change Sampling Procedures Mid-Study Without Documented Justification Do Not Change Sampling Procedures During Ongoing GMP Studies Remember: GMP mandates that sampling procedures remain fixed throughout the study. Any deviation must be pre-approved by QA and supported by documented justification. Why This Matters in GMP Sampling is a critical component in the verification of product...

Never Override System Alarms Without Proper GMP Investigation

digi — Tue, 08 Jul 2025 00:54:03 +0000

Never Override System Alarms Without Proper GMP Investigation Do Not Override GMP Alarms Without Justification and QA Review Remember: Overriding system alarms without documented investigation violates GMP and may hide critical issues affecting product quality or data integrity. Why This Matters in GMP Alarms generated by environmental monitoring systems, stability chambers, cold storage units, or...

Verify Batch Yield Calculations Before Finalizing Manufacturing Records

digi — Sat, 03 May 2025 02:22:43 +0000

Verify Batch Yield Calculations Before Finalizing Manufacturing Records Always Verify Batch Yield Calculations Before BMR Finalization Remember: Confirm all yield values before signing off on the Batch Manufacturing Record (BMR). Why This Matters in GMP Yield reconciliation is a critical component of GMP manufacturing that ensures raw materials are efficiently converted into finished products. Yield...