How to get GMP certification in India What is GMP certification? In this blog, we are going to tell you about the GMP certification in India. GMP certification plays a really important role to maintain the standards of pharmaceutical manufacturing in India. GMP means Good Manufacturing Practice is a term which describes the management system of pharmaceutical manufacturing in a country. This ensures the quality of the pharmaceutical products in India. There are some certain guidelines for maintaining the quality of pharmaceuticals products. GMP certification process have some common industry standards and they test the pharmaceuticals products according to those standards. This is how GMP certification ensures the quality of the pharmaceutical products. GMP certificate is signed and issued by the joint commissioner of the food and drug administration under the program of world health organisation – GMP certification programme. The Good Manufacturing practice certificate ensures the complete sanitation and cleanliness in the manufacturing plant and it also includes complete documentation and records. GMP certificate also ensure that employees who are for the pharmaceuticals company are well qualified. This certificate also verify the quality of all the equipment’s. Every type of process validations are covered in GMP certificate. On the basis of this information you may think that applying for the GMP certification would be a very difficult process but that’s not the case actually. GMP certification is a simple process and manufacturer have the freedom to choose specific controls and standards in their own manufacturing plant.
Objectives of GMP certification: There some major objectives behind the GMP certification to reduce the risk with the pharmaceuticals products. We all know that pharmaceuticals products carries some risks with them like:
If there is some type of unwanted elements or uncleanliness present in the pharmaceutical products then it may seriously bad impacts on someone’s health or may cause death. The labels on the containers of the medicine have to be correct and accurate otherwise it may result the wrong consumption of the product (medicine). If pharmaceutical product contains too much or too less active ingredients then it may cause negative impact on one’s health. All aspects of manufacturing are covered under the GMP certification which includes raw materials, specifics regarding locations and equipment, personnel training, and personal hygiene. It contains all the details on the complete processes which forms the complete pharmaceutical product and it could affect the quality of the products.
What are the documents required for GMP certification? Here is a list of documents which are necessary to apply for GMP certification: 1. Primarily, GMP application requires the name of the applicant and after that address of the applicant, phone number, fax, and email will also require. 2. Applicant will require a copy of his manufacturing license.
3. Applicant will require a list of approved products 4. Applicant will require a master file for the site which is also known as plant master file. Plant master file contains all the information about the manufacturing plant. 5. Applicant must have all the information about the complete formulation of the product. Information about the Finished Formulation. 6. Applicant have to the list of technical personnel who are working there and also the details of their qualification, experience and approval status. What is the Procedure for GMP Certification?
Here is a step by step procedure for GMP Certification: Application process – applicant have to fill all the essential information about the company in the application. Commissioner of food and drug administration is an authority which will accept the application for GMP certification and they will also maintain a certain record on the GMP database. Application review - An officer panel will see and review the application and they will check that the product meets all the consistency requirement and standards or not. Application analysis – Then department will analyse the application and they will give a value citation to complete the requirements in the product to come into the standardisation. Certification – After the complete audit of the documents and review of the application, applicant can expect to get the certificate from the authority. (Validity – The GMP certificate have the maximum validity of three years)
Conclusion GMP certification is really important to all the pharmaceutical firms so that they follow all the major standards for their products. For more information you can visit our website https://www.corpseed.com/?gclid=Cj0KCQjwio6XBhCMARIsAC0u9aHLu1ymziluc2ybuKaLsANHWQK4 Tv7zayEd67hkHo2ZjaFJjjItaSkaAv7-EALw_wcB and contact our consultant as well.