GMP ConsultantsGMP Certification General:-
GMP is an abbreviation used for Good Manufacturing Practices. GMP regulations are a set of guidelines that must be followed by the manufacturers, processors, and packagers of drugs and pharmaceutical products. It is necessary by law for them to get GMP certification from the regulatory authorities in order to be able to manufacture pharmaceutical products. The GMP guidelines are also applicable on some of the processed food products. These guidelines mentioned in GMP include necessary steps that must be taken in order to keep the quality and consistency of the products at best level. Several defects must be prevented from the very first step of the manufacturing process as they cannot be eliminated from the final products after testing. This helps in protection of the consumers by providing them adulteration free products.
The manufacturers who obtain GMP certificate have to follow several steps that are mentioned in the GMP guidelines in order to be compliant with GMP. Here are some of the GMP certification requirements that must be fulfilled by the manufacturers.
• There must be a written record of all the procedures included in the manufacturing process of the product.
• The manufacturing area of the company premises must have the best level of cleanliness and hygiene.
• The environment in the manufacturing area must be controlled and free from any contaminants that may hamper the quality of the products.
• Whenever there is any major change made in the manufacturing process that can affect the final quality of the products, then it must be validated correctly.
• There must be a written record of the qualification of each and every staff member.
• The members of the staff must be trained to keep the best level of personal hygiene as well as hygiene in the company premises.
• During the manufacturing process, a record must be maintained which indicates that every required step for the manufacturing of the products was taken properly.
• There must be a system that addresses the complaints and grievances.
• Proper training should be conducted for operators to maintain a record and the operations involved in the manufacturing process.
If a product is GMP certified, consumers also prefer such products because it ensures the best quality. The GMP guidelines do not tell how to manufacture a product, but they are open end guidelines that mention how to keep the best consistency and quality of products along with keeping them free from adulteration.
We at ISOCONSUTANTSINDIA, understand the GMP certification process and provide our services to clients who are willing to avail this certification. We have a team of skilled GMP consultants who can assess the requirements of the businesses to be GMP certified and help them in obtaining GMP accreditation with a trouble free process. Our consultants not only help you in obtaining the certification but they also suggest you the ways in which you can minimize the GMP certification cost and save money. With ISOCONSULTANTINDIA, you will have a trouble-free procedure for GMP certification of your business.
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