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ISO 9001:2008 (Quality Management System) ISO 14001:2004 (Environment Management System) ISO 18001:2007 (Occupational Health & Safety Management System) ISO 22000:2005 (Food System Management System) ISO 13485:2003 (Medical Device System) EN 16001 (Energy Management) ISO 27001:2005 (Information Security Management System) TS-1649 (Quality Management System For Automotive Suppliers)
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GMP Certification

Good Manufacturing Practice (GMP)

"Good manufacturing practice" or "GMP" is required being adapted in the manufacturing of pharmaceuticals or drugs, active pharmaceutical ingredients, diagnostics, foods and medical devices. GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product. Many countries have regulatory requirements that Pharmaceutical and Medical Device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. The concepts of all of regulatory guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient. Therefore, complying with GMP is a mandatory aspect in manufacturing of the above said items.

GMP– National and International statements

Worldwide, there are different official regulatory statements and guidelines about, Good Manufacturing Practices. The few are listed below:

  • The US Current Good Manufacturing Practices for Finished Pharmaceuticals regulations
    (the “US cGMPs”)
  • The Guide to Good Manufacturing Practice for Medicinal Products of the European Union
    (the “EC GMP Guide”)
  • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
  • WHO good manufacturing practices.
  • The other guidelines and regulation referred by the pharmaceutical manufacturers are as under
  • Schedule M “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” The Drugs and Cosmetics Act And Rules, India.
  • PIC/S Guide to Good Manufacturing Practice for Medicinal Products.
  • Centre for Drug Evaluation and Research (CDER)

We offer GMP Consultancy service for pharmaceuticals and Medical Device manufactures to compile with respective regulatory requirements mentioned below

  • GMP Training
  • GMP Documentation
  • GMP internal audit
  • Schedule M Compliance