GMP Certification In India

GMP Certification In India

Anything that is being manufactured has to go through the quality analysis process. This is severely necessary in the cases of the pharmaceutical and food industry too. Anything wrong and incorrect manufacturing of it can damage and sometimes cost a human life.

Good Manufacturing Practice a.k.a GMP certificate is a quality check certificate and is used globally. It helps control the quality of manufacturing, test it, and assuring the quality manufacturing of almost all pharmaceutical products.

This certificate defines the guidelines which assure the quality of the pharma products. A company holding GMP certification in India ensures that they follow all the necessary quality standard norms

Let us understand in detail about the GMP Certificate.

What is GMP Certification?

We know that every certificate assures the value or the quality of something. These certifications and further legalizations of the same are required on the various stages of personal and professional life cycles. It provides the high authentication of the product, document, or services provided.

The same is the case with GMP certification. Like mentioned before about the GMP, it is a certificate issued mainly to the pharmaceutical and natural food manufacturers. It has a set of guidelines that affirm that the product is safe to use. Maintaining quality standards is of utmost importance in the medical industry. Any small mistake can affect the health of the user and may cause loss of life too.

Medicine and food are two fields that are directly related to human health. There shouldn’t be any scope of quality mistakes as it will hugely affect human life. To avoid this Good Manufacturing Practice Certificate comes with a set of guidelines to be followed by the manufacturing unit.

This certificate is responsible for the safety and quality of the product say medicine or the probiotic manufactured by a certain company. GMP also assures the usability and the quality of the medical devices too.

Let us understand how this term came into use

In 1968, WHO drafted the first text on GMP. Later in 1969, the first version of the WHO Certification scheme about the quality control on pharmaceutical manufacturing was recommended in the World Health Assembly.

The World Health Organisation then accepted GMP as the most integral part of the certification scheme. In the year 1991, the Expert Committee on Biological Standardization adopted an additional annex on biomedical products. It helped in establishing the proper system and created a general approach to the quality management of the medicines. WHO added the following things in this certification-

  • – Medicines
  • – Vaccines
  • – Blood and Related Products
  • – Cells and Tissue Therapies
  • – Antigens
  • – Biopharmaceutical Products
  • – Medical Devices

And many others

Many countries have adopted these provisions and concepts to define their own GMP guidelines. Also, 100+ countries have included WHO GMP as a standard in their medical laws. Even today, WHO GMP is used as a base for prequalification for the new vaccines for the approval of the aids from the UN agencies. That is a standard of which is being followed.

Now we know how the term GMP was formed and what value it has. We need to understand the procedure to proclaim the same.

What Is the Purpose of GMP?

Good Manufacturing Practice reduces the number of risk factors involved in pharmaceutical manufacturing. There are several risks involved such as-

  • – Unhygienic and uncleanliness in the product will affect the health and may lead to loss of life.
  • – Improper labeling on tablets or containers. It may imply that the patient takes incorrect medications.
  • – Accuracy of ingredients.
  • – Medicines causing an adverse effect
  • – Medicines not showing the determined results.

GMP regulates every aspect of the manufacturing starting from raw material, area of manufacturing, equipment involved, vicinity and sanity, training to staff, and their hygiene habits. It assesses the entire procedure until the final product arrives and will impact the quality of the pharma products.