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Current Good Manufacturing Practice (GMP)

The Quality System for FDA-regulated products (food, drugs, biologics, and medical devices) are 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 which is similar to ISO 13485.

The manufacturer of finished pharmaceutical products must comply with 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 considered as 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

 
LIBERTY MANAGEMENT GROUP LTD.
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Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@libertymanagement.us