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Good Manufacturing Practices(GMP)

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SIS Certifications is NOW Eligible to Issue ISO 42001 Certification       SIS Certifications is the ONLY ISO Certification body in India which is accredited for ISO 41001 Certification by IAS.       SIS Certifications is NOW accredited by IAS for ISO 27001:2022 Certification.

What is Good Manufacturing Practices GMP Certification ?

Good Manufacturing Practices (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 Good Manufacturing Practices (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.

Basic Principles of all Guidelines

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 Good Manufacturing Practices GMP Certification

– It demonstrates the organization’s credibility in ensuring product quality and safety.

 

– 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.

Frequently Asked Questions about Good Manufacturing Practices (GMP)

Question : What is Good Manufacturing Practices (GMP)?

 

Answer : Good Manufacturing Practices or GMP is a system that consists of processes, procedures and documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards.

 

Question : When Did The Current Code Of GMP Become Mandatory?

 

Answer : The current Code of GMP was introduced on 29 July 2009 with a transition period up to 30 June 2010. It became mandatory from 1 July 2010.

 

Question : What is the primary objective of Good Manufacturing Practices (GMP)?

 

Answer : The primary objective of GMP is to reliably deliver great medications or clinical gadgets that fulfill the global guidelines required for capably oversaw medicinal services. Procedures utilized in manufacture are deliberately controlled, and any progressions to the procedure must be assessed.

 

Question : What is the difference between GMP and cGMP?

 

Answer : GMP: Good Manufacturing Practices GMP is the 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. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: Cross-contamination (in particular of unexpected contamination) and Mix-ups (confusion). cGMP: Current Good Manufacturing Practices. This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.

 

Question : Which information should master document carry on every page not just one of the pages to meet GMP ?

 

Answer : Page number, document reference number and authorizing signatures.

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