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Current Good Manufacturing Practice (GMP)

The Quality System for FDA-regulated products (food, drugs, biologics, and medical devices) is known as current good manufacturing practice (cGMP).

The finished medical device manufacturers planning to market their medical devices must comply with Current Good Manufacturing Practice (GMP) as per 21 CFR part 820, similar to ISO 13485.

The manufacturer of finished pharmaceutical products must comply with the Current Good Manufacturing Practice (GMP) as per 21 CFR part 211. FDA inspects drug and API manufacturing facilities worldwide, and if found not complying with cGMP regulations, the drug manufactured at the facility may be considered adulterated.

LMG can assist you with

  • GAP Analysis
  • Facility design and environmental controls
  • Documentation
  • Internal Audit
  • Implementation
  • FDA pre-audit and post-audit support

Drug GMP requirements

Medical Device GMP Requirements

FDA 483 - FDA warning letter

Hand Sanitizer GMP

ISO Certification

ISO Certification body list

ISO 9001 Certification