cgmp Consultants

cGMP Consultants

GMP - Good Manufacturing Practices

 
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
 
 
GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. All employees working in direct contact with food, food contact surfaces and food packaging must conform to hygienic practices. This protects against food contamination by microorganisms or unwanted material. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. 
 
 
WHO has established detailed guidelines for Good Manufacturing Practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
 
 

cGMP:

Usually see “cGMP” – where c = current, to emphasize that the expectations are dynamic
 
 

GMP Requirements

  • Product
  • Procedures
  • Facilities
  • Product 
 

The basic requirements of the product are:

  • Product design
  • Stability Studies
  • Process validation
  • Procedures
 
All actions taken in the facility which leads to the production of the final product as per specification
 
 

Facilities

 
This encompasses the building, machinery, services and utilities, manpower etc. These are guided towards making a properly designed product.
 
 

GMP consists of various activities which can be grouped together as follows:

 
  • Training - induction, ongoing, refresher etc. along with such documents like SOP, training calendar, assessment etc.
  • Cleaning, sanitation and hygiene -  may also include workers entry  procedure, cleaning of the ;premises etc.
  • Validation and calibration  - qualification of machinery, equipment  etc.
  • Storage - apart from normal ware-housing facilities, this should also address quarantine, procedure Etc.
  • Movement of manpower, material - Uni-flow movement, movements control etc.
  • Quality assurance – Quality control
  • Documentation - must include MFR, BPR, SOP Documents, control & distribution, cleaning, training, and document regulating and recording other  activities
  • Change control – Self inspections and audits
 
 

WHO GMP ensures the following:

  • Avoidance of Cross- Contamination
  • Prevention of Mix-ups
  • Provide Traceability
  • Accountability of actions
  • Responsibility
  • Product Performance Guarantee
 

A series of reports known as the WHO Technical Report Series (TRS) are available.

 
     TRS 823     (1992)
     TRS 863     (1996)
     TRS 885     (1999)
     TRS 902     (2002)
     TRS 908     (2003)
     TRS 917     (2004)
 
 
To know more in details please write to us on ceo@isoconsultantonline.com or call

+919962590571

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