GMP Certificate

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)

GMP Consultants ​

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

  • Layout design for Medical Device and pharmaceutical manufacturing
  • GMP Training
  • GMP Documentation
  • GMP internal audit
  • Schedule M Compliance

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :-
Telephone :- +91 - 9881946595

Design & Developed By : Logic Palace Systems and Softwares
Back to Top