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
- Layout design for Medical Device and pharmaceutical manufacturing
- GMP Training
- GMP Documentation
- GMP internal audit
- Schedule M Compliance
More about GMP turnkey projects
More information about GMP Cleanrooms
Schedule M (111)
We had a special team of GMP consultants for Medical device manufactures to compile various regulatory requirements followed by India, USA, EU etc.etc
Out GMP / Schedule M Consultants provide complete technical support for schedule M (111- Medical Device) compliance as per CDSCO requirements in India
- Renovation of existing Facility
- New Facility creation
- Clean room Consultation
- GMP Training
- Schedule M(111) documentation for medical device Industries
- GMP Certificate
- Manufacturing Licence ( Schedule M)
Our GMP consultants and auditors are Post Graduates and Graduates in Pharmacy, Microbiology and Engineers to perform consultancy and audits to assess or implement GMP (Good Manufacturing Practices).
Contact us to find out know more about our GMP Consultancy Services.