HACCP, GMP and GAMP5
HCCP is the Hazard Analysis Critical Control Points system that was developed to ensure the safety of food for United States astronauts nearly 30 years ago. It identifies any hazards that must be prevented eliminated or reduced. HACCP system is internationally accepted as the system of choice for food safety management. It is a preventative approach to food safety based on the following seven principles:
- identify the critical control points (CCPs) at the steps at which control is essential
- establish critical limits at CCPs
- establish procedures to monitor the CCPs
- establish corrective actions to be taken if a CCP is not under control
- establish procedures to verify whether the above procedures are working effectively
- establish documents and records to demonstrate the effective application of the above measure
A Good Manufacturing Practice (GMP) is a production and testing practice that helps to ensure a quality product. GMP guideline give us a guidance for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. The term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls.
The GAMP5 guidelines relate to the Regulated company and their good manufacturing practices, the responsibility for full compliance of relevant standards ultimately stops there. In GAMP 5 however greater importance has been placed on Supplier Leverage, that is the supplier of a product or service should be aware of the guidelines and adhere to them, this has the effect that Regulated companies can use the suppliers documentation, testing, verification, and quality plan, to prove compliance to regulation authorities.
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