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GMP Certification

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Good manufacturing practices (GMPs) are guidelines that provide a system of processes, procedures and documentation to assure a product has the identity, strength, composition, quality and pureness that appear on its label. A GMP is a system for ensuring that products are constantly produced and controlled according to quality standards. It is designed to reduce the risks involved in any pharmacological production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are important for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are constantly followed at each step in the manufacturing process.

CE Certification’s GMP Registration Program enables manufacturers to become freely registered by CE Certification to meet GMP requirements. The program is open not just to manufacturers of dietary supplements but also to manufacturers of ingredients and raw materials, as well as distribution, warehousing and packaging companies, who want to demonstrate their commitment to public safety.

GMP regulations address issues including recordkeeping, employees qualifications, sanitation, equipment confirmation, 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 business.

A consumer usually cannot discover (through smell, touch, or sight) that a drug product is safe or if it will work. While GMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch like, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets, so that most of the batch can be used for patients rather than demolished by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the GMP regulations to assure that quality is built into the design and manufacturing process at each step. Facilities that are in good condition, equipment that is correctly maintained and calibrated, employees who are trained and fully qualified, and processes that are reliable and reproducible, are a few examples of how GMP requirements help to assure the safety and efficiency of drug products.

Benefits of GMP Certification:

  • Increase consumer confidence in your products.
  • Demonstration of your commitment to producing and trading safe and quality food.
  • Enhancement of your food safety management system.
  • Prepare you for assessment by regulatory authorities and other stakeholders.
  • Prepare you for HACCP certification or other food safety and quality management system.
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