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Good Manufacturing Practices(GMP)

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What is Good Manufacturing Practice GMP Certification ?

Good Manufacturing Practice (GMP) is a certification of proof of maintaining consistency in the production of goods as per the quality standards. It helps in minimizing the risks in any stage of the production that cannot be eliminated through testing the final product.

 

GMP overviews all the aspects of production, from raw materials to production units, equipment, training, and personal hygiene of the staff. The quality of the finished product can be influenced by detailed, written procedures. A systemized documentation acts as proof that the procedures in the manufacturing process are followed consistently.

 

The GMP Certification provides a framework for manufacturing, testing, and assuring the quality and safety of food and other products. There are many countries that have put forward legislation according to which the food, pharmaceutical, and medical device manufacturers should follow GMP procedures and create their own guidelines in order to be compliant with the legislation.

The common basic principles of all guidelines are as follows:

  • Hygiene : The manufacturing facility must be clean and hygienic.

 

  • Prevention of cross-contamination of food or drugs from adulterants by maintaining controlled environmental conditions.

 

  • A clear, defined, and controlled manufacturing process. Manufacturing processes are clearly defined and controlled. Validation of all critical processes are done to ensure consistency and compliance.

 

  • Evaluation of changes in the manufacturing processes that are kept under control.

 

  • Clarity and unambiguity in written instructions and procedures.

 

  • Training of operators to carry out the procedures and document them.

 

  • Either manual or instrumental records are made during the manufacture to demonstrate that the right steps were taken in order to ensure the quality and quantity of the products as per the expectation. Any deviation is investigated and documented.

 

  • Manufacturing and distribution records should be maintained in order to ensure the traceability of the product or batch.

 

  • Minimizing the risk to the quality of products when they are distributed.

 

  • There should be an availability of a system to recall any batch from sale or supply.

 

  • Complaints about marketed products are evaluated, the causes of defects are analyzed, and appropriate measures are taken so that the recurrence of defects can be prevented.

 

  • The ultimate goal of implementing GMP in any organization is to safeguard the health of customers by producing good quality food, medicine, medical devices, active pharmaceutical products, and other products.

 

  • Even if the product passes all the specification tests, it is still deemed as “adulterated” if the manufacturing facilities do not comply with the GMP guidelines.

 

  • GMP Certification guidelines are general principles that must be followed during the manufacturing processes. They are not prescriptive in nature. It is the responsibility of an organization to set up GMP guidelines for the purpose of their quality program. It is the company’s responsibility to determine the most effective and efficient quality process.

Benefits of GMP Certification

 

  • Develops awareness and habits among the employees for the purpose of good production/operation.

 

  • Reduction of safety risk

 

  • Timely detection of problems in production and management as well as a reduction in cost.

 

  • Better understanding and compliance with the relevant regulations

 

  • Enhancement of international credibility and image

 

  • Improvement in customers’ confidence in the organization.

 

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