FDA 21 CFR 211.94 – Pharma GMP

Inspect Filled Ampoules for Visual and Physical Defects Post-Filling

digi — Wed, 24 Sep 2025 05:20:29 +0000

Inspect Filled Ampoules for Visual and Physical Defects Post-Filling Always Inspect Filled Ampoules for Visual and Physical Defects Remember: Always perform post-filling inspection of ampoules to detect cracks, seal anomalies, or particulate matter — essential for sterility and GMP compliance. Why This Matters in GMP Filled ampoules, commonly used for sterile injectables, are vulnerable to...

Avoid Excessive Vacuum Pressure in Blister Machines During GMP Packaging

digi — Wed, 17 Sep 2025 01:25:18 +0000

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...

Validate Strip and Bulk Container Packaging for Integrity in GMP Operations

digi — Tue, 09 Sep 2025 04:43:25 +0000

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...