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ISO 9001 : 2015 Quality Management System
ISO14001:2015
Environmental Management System
OHSAS 18001 IS NOW ISO 45001
Occupational Health and Safety Management System
ISO 22000 : 2005
Food Safety Management System
ISO 27001:2013
Information Security Management System
ISO 13485 Medical Devices
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Hazard Analysis Critical Control Point
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Current Good Manufacturing Practice

Current Good Manufacturing Practice (cGMP) is imposed by US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
cGMp certification includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

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.

Significance of cGMP certification

Significance of cGMP certification
The importance of cGMPs, The FDA designs cGMP regulations to “assure quality is built into the design and manufacturing process at every step.” The consumer has to trust that federally regulated products are safe.
Benefits of cGMP certification

  • Operating costs is very low and avoid penalties.
  • Maintain a Green Process to deliver Product or Service provision,
  • Provide a Green System towards a Sustainable Business.