GMP Certification Consultants
GMP is an abbreviation that stands for Good manufacturing Practices. It is a standard that presents a set of complete guidelines that state the requirements for a better manufacturing process that must be adopted by the pharmaceutical sector in order to provide the best quality of products to the customers. The manufacturers, distributers an processes of medical products and pharmaceutical drugs must follow the guidelines of GMP in order to provide the best health and ensure safety of the consumers. It is mandatory by law, for every firm involved in the business of pharmaceutical products, to have GMP certification by an assessing authority. The GMP guidelines must be applied on some types of processed food products also. Some defects in these products cannot be cured once they are induced in the products hence it is essential to prevent them from beginning and this can be done with the help of GMP guidelines. In this way, the manufacturers can ensure the best level of safety of the consumers.
To be granted a GMP certificate, an organization has to fulfill several points that are given the guidelines of GMP to achieve compliance with the standards. Here are some of the GMP certification requirements:
1. All the procedures must be recorded in written documents that are involved in the manufacturing of drugs and other pharmaceutical products.
2. Best level of hygiene must be maintained in the company premises where the products are being manufactured.
3. The manufacturing unit of the company must have a controlled environment that helps in keeping any contaminant out and keep the area contamination free.
4. Whenever there is a major change in the process, it must be properly validated.
5. There must be a written record of the qualification of every staff member must be maintained.
6. The complaints and grievances must be addressed with the help of an efficient system.
7. The staff members must be given training to maintain best level of hygiene in company and at personal level.
8. Proper training should be given to the operators so that they can maintain the quality record efficiently.
When a manufacturer of Pharmaceutical products is granted a GMP accreditation, it helps in making the customers confident about the quality and safety of the products provided by that manufacturer.
If you are also planning to apply for GMP, CE Marking India can give the best assistance during the GMP certification process. Our efficient and skilled consultants understand the process very deeply and are able to provide the best GMP certification cost to our clients. In addition to that, our consultants also help our clients in passing the regular audits that are conducted on annual basis after the certification.