Introduction Of Good Manufacturing Practices (GMPs)

By: Pharma Tips | Views: 10809 | Date: 29-Mar-2011

Good Manufacturing Practice (cGMP) is the term used to define the latest best practice for the manufacture of pharmaceutical and allied products in various countries around the world. In New Zealand, this requirement is set out in the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods published by the Ministry of Health In practice, these provisions mean compliance with the requisite domestic and/or international legislation and regulations.

1. INTRODUCTION
   
   
DEFINATION:
                  Good Manufacturing Practice (cGMP) is the term used to define the latest best practice for the manufacture of pharmaceutical and allied products in various countries around the world. In New Zealand, this requirement is set out in the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods published by the Ministry of Health In practice, these provisions mean compliance with the requisite domestic and/or international legislation and regulations.

Good Manufacturing Practices (GMPs)

PRINCIPLE OF “CGMP” :
              
                                The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practices that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
            
                               Good Manufacturing Practices (GMPs) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification. GMP is concerned with both production and quality control. 1
Worldwide, there are different official regulatory statements and guidelines, national and international, on Good Manufacturing Practices for pharmaceutical (or “drug” or “medicinal”) products. They may be regulations  (as in the US, Japan or Korea), directives (as in the EU), guides (as in the UK), codes (as in Australia), or WHO code (as in many Southeast Asia Countries). Out of them, following stands out as being the most influential and most frequently referenced:                                                                                 
   
-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); Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients.

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