GMP maintenance – Pharma GMP

Use Only OEM Parts for Equipment to Maintain GMP System Integrity

digi — Wed, 24 Sep 2025 19:30:40 +0000

Use Only OEM Parts for Equipment to Maintain GMP System Integrity Do Not Replace Equipment Parts with Non-OEM Alternatives in GMP Systems Remember: Always use original equipment manufacturer (OEM) parts for GMP systems — substitutes may affect validation status, performance, and compliance. Why This Matters in GMP GMP equipment is qualified using specific components that...

Inspect Tablet Compression Tooling Regularly to Detect Wear and Damage

digi — Mon, 08 Sep 2025 04:54:48 +0000

Inspect Tablet Compression Tooling Regularly to Detect Wear and Damage Routinely Inspect Tablet Compression Tooling to Prevent Quality Defects Remember: Always check punches and dies for wear or damage before and after use — tooling degradation can compromise tablet quality and uniformity. Why This Matters in GMP Tablet punches and dies are precision components that...

Do Not Store Broken Tools in Pharmaceutical Maintenance Rooms

digi — Sat, 23 Aug 2025 10:42:16 +0000

Do Not Store Broken Tools in Pharmaceutical Maintenance Rooms Keep Maintenance Rooms Free of Broken or Unserviceable Tools Remember: Never store damaged tools in GMP maintenance areas — they compromise cleanliness, tool traceability, and equipment repair quality. Why This Matters in GMP Maintenance tools are frequently used to service GMP-critical equipment such as granulators, tablet...

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...