Good Manufacturing Practice (GMP) Certification

Good Manufacturing Practices (GMP) certification from CE Marking Mumbai ensures the integrity of your food manufacturing process as well as your compliance with food safety regulations. Assurance of the safety and quality of food is an important consideration for consumers today. A GMP is an important enhancement to your food safety management system, which increases your customers’ confidence in your commitment to trading and producing safe, high quality food.

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.

Certification Process:

After the companies build and enhance their internal procedures and system, they call the governmental agency which is responsible for GMP certificate issuance. In Palestine, this is the Palestinian Ministry of Health and in the United States it is the Food and Drug Administration (FDA). Once the Ministry of Health receives the request, its GMP experts will inspect all aspects of the company to ensure standards compliance. Inspection will include ingredients used, drug validity, storing and packaging conditions, research and development, quality control, spaces and layout.

It is important to note that inspections are different from auditing, as inspections include demonstrations of some experiments to ensure compliance. GMP inspection is much more complicated than ISO9001 auditing, since GMP includes detailed technical requirements which need more complicated procedures than ISO9001.

According to the GMP inspection results, the company will or will not be GMP certified. If the company is not able to achieve the GMP requirements, the inspectors will give the company another chance to achieve the requirements and once it fulfills these requirements it will be GMP certified.

Benefits of the GMP:

The following points are GMP general benefits:

  • Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
  • Increases senior management confidence in the preparedness of manufacturing facilities for inspection
  • Decreases the time and cost for companies selecting third-party testing and product certification if using GMP registered contract manufacturer; which is a national program that is designed to provide a system of processes, procedures, and documentation to ensure that the product produced has the identity, strength, composition, quality, and purity that it is represented to possess
  • Manufacturers of dietary supplements that comply with GMP requirements receive certificates and are listed on the NSF website
  • Available to all manufacturers of dietary supplements.
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