GMP is a regulation that guides the production and quality management of food, pharmaceutical and medical products. It is a set of mandatory standards applicable to pharmaceutical, food and other industries. For some companies, due to the lack of knowledge and understanding of GMP, their road to GMP certification can be very difficult.
Looking at the new version of GMP, its provisions are more specific, more instructive and operational, and also introduces new concepts of quality risk management and quality system management. Before GMP certification, you should patiently analyze and interpret it, and do the following preparations.
1. All workshops, warehouses and positions should have written and approved SOPs or standards that are valid versions and can be accessed by staff at any time.
2. With raw and auxiliary materials, packaging materials, packaging materials and indeed good acceptance, sampling, inspection, warehousing and distribution of management systems and related procedures, the implementation of the records and have traceability.
3. Warehousing: a clear functional partition, should include receiving, to be inspected, sampling, non-conforming products, qualified products, withdrawal and other areas, the state of clear identification, goods, card, account consistent, non-conforming products stored in the area, with ventilation, insect and rodent-proof measures, labels, manuals should be managed by a special person, special cabinets, important items, valuables, hazardous materials should be stored in special cabinets.
4. Warehousing area high set of raw and auxiliary materials, packaging materials in direct contact with the drug sampling room, if not set up a sampling room, then measures should be taken to prevent contamination and cross-contamination.