equipment integrity – 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...

Never Use Scratched Stainless Steel Scoops in GMP Manufacturing

digi — Wed, 23 Jul 2025 21:35:43 +0000

Never Use Scratched Stainless Steel Scoops in GMP Manufacturing Do Not Use Damaged or Scratched Scoops in GMP Production Areas Remember: GMP requires that stainless steel scoops and utensils be free of scratches or damage that may harbor contaminants or residues. Why This Matters in GMP Stainless steel scoops are used for sampling, dispensing, and...

Never Use Mechanical Stirrers with Cracked Blades in GMP Areas

digi — Sat, 21 Jun 2025 12:01:53 +0000

Never Use Mechanical Stirrers with Cracked Blades in GMP Areas Avoid Using Mechanical Stirrers with Cracked Blades in GMP Manufacturing Remember: Mechanical stirrers with cracked blades pose contamination and safety risks—GMP requires that all equipment be damage-free and qualified before use. Why This Matters in GMP Mechanical stirrers are essential in blending APIs, excipients, and...