Tag: EU GMP Annex 15

Perform Recovery Studies After Swab Testing to Validate Cleaning Effectiveness

November 5, 2025November 14, 2025 digi

Perform Recovery Studies After Swab Testing to Validate Cleaning Effectiveness Do Perform Recovery Studies After Swab Testing in Cleaning Validation Remember: Swab testing must be supported by recovery studies — this confirms the method’s efficiency and validates cleaning effectiveness in GMP areas. Why This Matters in GMP Swab testing is a standard method for detecting…

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Verify Strip Pack Leak Test Results During Every GMP Shift

November 1, 2025November 14, 2025 digi

Verify Strip Pack Leak Test Results During Every GMP Shift Do Verify Strip Pack Leak Test Results During Every GMP Shift Remember: Always perform and document strip pack leak tests at every shift — packaging integrity is critical for maintaining drug stability and compliance. Why This Matters in GMP Strip packs are commonly used to…

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Conduct FAT and SAT for All New GMP Equipment to Ensure Compliance

September 20, 2025November 14, 2025 digi

Conduct FAT and SAT for All New GMP Equipment to Ensure Compliance Conduct FAT and SAT for New Equipment Before GMP Validation Remember: Always perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new GMP equipment — this ensures compliance, reliability, and readiness for qualification. Why This Matters in GMP FAT and SAT…

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Evaluate Worst-Case Scenarios in Cleaning Validation for GMP Assurance

September 19, 2025November 14, 2025 digi

Evaluate Worst-Case Scenarios in Cleaning Validation for GMP Assurance Assess Worst-Case Scenarios During Cleaning Validation Studies Remember: Always include worst-case conditions in cleaning validation to ensure your process can handle the most challenging product, surface, and equipment combination. Why This Matters in GMP Cleaning validation ensures that residues from one product do not contaminate the…

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Avoid Excessive Vacuum Pressure in Blister Machines During GMP Packaging

September 17, 2025November 14, 2025 digi

Avoid Excessive Vacuum Pressure in Blister Machines During GMP Packaging Do Not Use Excessive Vacuum Pressure on Blister Machines Remember: Avoid applying excessive vacuum during blister packaging — it can cause cavity deformation, product damage, and compromise packaging integrity. Why This Matters in GMP Blister packaging machines use vacuum pressure to draw forming film into…

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Validate Strip and Bulk Container Packaging for Integrity in GMP Operations

September 9, 2025November 14, 2025 digi

Validate Strip and Bulk Container Packaging for Integrity in GMP Operations Validate Packaging Integrity for Strip Packs and Bulk Containers Remember: Always validate the integrity of strip and bulk packaging — poor seals or barrier failures can compromise product quality and shelf-life. Why This Matters in GMP Strip packs and bulk containers are widely used…

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Develop Comprehensive User Requirement Specifications (URS) for GMP Equipment

September 6, 2025November 14, 2025 digi

Develop Comprehensive User Requirement Specifications (URS) for GMP Equipment Define Detailed URS Documents for Every GMP Equipment Purchase Remember: Always prepare a complete User Requirement Specification (URS) to guide equipment design, selection, and qualification in GMP settings. Why This Matters in GMP User Requirement Specifications (URS) define what the equipment must do — from capacity…

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Document Every Step of Cleaning-in-Place (CIP) Operations in GMP Equipment

September 2, 2025November 14, 2025 digi

Document Every Step of Cleaning-in-Place (CIP) Operations in GMP Equipment Thoroughly Document Every Step in Cleaning-in-Place (CIP) Operations Remember: Always document each parameter of CIP — flow rate, temperature, time, detergent concentration — to maintain GMP compliance and validation integrity. Why This Matters in GMP Cleaning-in-Place (CIP) is an automated method for cleaning the internal…

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Conduct Hold-Time Studies for Cleaned Equipment to Validate Storage Durations

September 2, 2025November 14, 2025 digi

Conduct Hold-Time Studies for Cleaned Equipment to Validate Storage Durations Validate Hold-Time for Cleaned Equipment Before Reuse Remember: Always conduct hold-time studies for cleaned equipment to define how long it can be stored before requiring re-cleaning under GMP. Why This Matters in GMP After equipment is cleaned, it may not be used immediately — it…

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Never Leave Production Equipment Idle Without Cleaning

August 19, 2025November 14, 2025 digi

Never Leave Production Equipment Idle Without Cleaning Do Not Leave Production Equipment Idle Without Performing Cleaning Remember: Always clean production equipment before and after idle periods to prevent contamination and maintain GMP compliance. Why This Matters in GMP Leaving production equipment idle without cleaning can create serious contamination risks in pharmaceutical manufacturing. Product residues left…

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