GMP Compliance

GMP stands for Good Manufacturing Practice or Current Good Manufacturing Practice. GMP is the quality system regulations for FDA regulated products. Each manufacturing establishments must develop, implement, and follow the GMP. The GMP for each establishment is unique so you cannot just copy and implement a GMP system from similar industry or from parent company. FDA audit establishments to verify the GMP Compliance, if not complying FDA will issue FDA 483 or warning letter.

GMP or quality system regulations for each type of industry is different, medical device industry need to follow the GMP as per 21cfr 820 whereas the drug industry need to comply with GMP as per 21 CFR 210 or 211. The GMP for food industry is as per 21 CFR 110 for human food and 111 for dietary supplements.

Implementation of proper GMP will help an organization to maintain the quality of their products and make sure to complying with applicable specifications and regulations.

If you are looking for GMP Compliance for medical device or drug LMG can help you.

  • Our services include
  • Quality Manual
  • Quality system procedures
  • Internal audit
  • GAP Analysis
  • FDA audit support
  • 21 CFR 820 maintenance