maintenance SOP – 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...

Maintain Separate Logs for Preventive Maintenance in GMP Facilities

digi — Sun, 22 Jun 2025 22:11:47 +0000

Maintain Separate Logs for Preventive Maintenance in GMP Facilities Maintain Distinct Preventive Maintenance Logs to Ensure GMP Equipment Compliance Remember: GMP requires dedicated preventive maintenance logs—separate from breakdown records—to verify routine servicing and ensure equipment reliability. Why This Matters in GMP Preventive maintenance ensures that equipment remains in qualified condition, minimizes unexpected downtime, and prevents...

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...