FDA 21 CFR 211.63 – Pharma GMP

Define Alert and Action Limits for Compressed Air in GMP Processes

digi — Mon, 10 Nov 2025 23:44:10 +0000

Define Alert and Action Limits for Compressed Air in GMP Processes Do Define Alert and Action Limits for Compressed Air in GMP Facilities Remember: Compressed air must be monitored using scientifically justified alert and action limits — this ensures product protection and early deviation detection. Why This Matters in GMP Compressed air is frequently used...

Never Store Instruments Inside Fume Hoods in GMP Laboratories

digi — Mon, 10 Nov 2025 10:38:00 +0000

Never Store Instruments Inside Fume Hoods in GMP Laboratories Don’t Store Instruments Inside Fume Hoods in GMP Laboratories Remember: Fume hoods are designed for hazardous operations — not for instrument storage. Storing equipment inside them disrupts airflow and increases corrosion risk. Why This Matters in GMP Fume hoods are engineered to contain and exhaust hazardous...

Do Monitor Compressed Air Points of Use for GMP Purity and Safety

digi — Wed, 29 Oct 2025 05:06:48 +0000

Do Monitor Compressed Air Points of Use for GMP Purity and Safety Do Monitor Compressed Air Points of Use for GMP Compliance Remember: Regularly test compressed air at the point of use — it must meet microbiological, particulate, and oil vapor standards to ensure product and process safety. Why This Matters in GMP Compressed air...

Monitor Compressed Air at Points of Use to Ensure GMP Compliance

digi — Tue, 28 Oct 2025 15:02:39 +0000

Monitor Compressed Air at Points of Use to Ensure GMP Compliance Do Monitor Compressed Air at Points of Use to Maintain GMP Integrity Remember: Compressed air must be tested at every point of use — it’s a critical utility in GMP manufacturing and must meet defined microbiological and particulate standards. Why This Matters in GMP...

Revalidate Water for Injection (WFI) Generation Systems Periodically

digi — Sun, 26 Oct 2025 03:08:07 +0000

Revalidate Water for Injection (WFI) Generation Systems Periodically Do Revalidate Water for Injection (WFI) Generation Systems Periodically Remember: Perform periodic revalidation of WFI systems to ensure continued microbial quality, equipment performance, and GMP compliance. Why This Matters in GMP Water for Injection (WFI) is a critical utility used in sterile product manufacturing, cleaning of product-contact...

Perform Equipment Gap Analysis Annually in GMP Facilities

digi — Mon, 20 Oct 2025 13:38:25 +0000

Perform Equipment Gap Analysis Annually in GMP Facilities Do Conduct Annual Equipment Gap Analysis in GMP Facilities Remember: Perform a structured equipment gap analysis annually to identify outdated systems, compliance gaps, and opportunities for preventive upgrades. Why This Matters in GMP Pharmaceutical manufacturing equipment must consistently meet GMP standards for performance, reliability, and compliance. Over...

Never Operate UV Lamps Without Periodic Intensity Checks

digi — Sat, 27 Sep 2025 20:57:42 +0000

Never Operate UV Lamps Without Periodic Intensity Checks Don’t Use UV Lamps Without Verifying Their Intensity Periodically Remember: Always perform periodic intensity checks on UV lamps — failing to do so risks microbial contamination and non-compliance with GMP standards. Why This Matters in GMP Ultraviolet (UV) lamps are frequently used in GMP facilities for microbial...

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...

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

digi — Sat, 20 Sep 2025 15:00:47 +0000

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...

Avoid Temporary Repairs for Critical GMP Utilities to Maintain Integrity

digi — Sat, 20 Sep 2025 01:02:00 +0000

Avoid Temporary Repairs for Critical GMP Utilities to Maintain Integrity Do Not Use Temporary Repairs for Critical GMP Utility Systems Remember: Avoid quick fixes for critical utilities — always implement permanent, validated repairs to maintain GMP system integrity and compliance. Why This Matters in GMP Critical utilities such as Water for Injection (WFI), HVAC systems,...