GMP stands for Good Manufacturing Practice and cGMP for current good manufacturing practice. It is of the Quality Assurance (QA) and ensures that manufacturing mett the standards. More specifically, it ensures that products are consistently produced and controlled to quality standards appropriate to their intended use.
QA is a wide ranging concept, it covers all matters which influence quality of product and it is defined as the sum of organised arrangements with object of ensuring med. products are of quality for intended use (GMP) and factors outside Orange Guide.
Quality control is GMP sampling, specifications, testing, organisation, documentation, release procedures to ensure the necessary and relevant tests are actually carried out and that materials not released to use or products for sale and supply, until their quality judged satisfactory.
Marketing Authorisation (=Product License)
any UK medicinal product--> PL/MA on packaging
2 basic requirements to gain:
1. Dossier (dif. for new chemical entity vs generic) with evidence on safety, efficacy and quality --> MHRA
2. pharmaceutical manufacturer holds:
Manufacturer's Licence (by MHRA) AKA Manufacture's Authorisation
site inspected by MHRA to ensure safety
GMP certificate (UK contract manuf.), letter of certificate (overseas contract manuf.)
In EU alternative ways to obtain MA. A central registration for the whole EU/ rgistration in one member state and a reciprocal arrangement to allow for a simplified MA in other member states.
FDA, PFSB, TGA, EMEA=MHRA
Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors
John Sharp
QA is a wide ranging concept, it covers all matters which influence quality of product and it is defined as the sum of organised arrangements with object of ensuring med. products are of quality for intended use (GMP) and factors outside Orange Guide.
Quality control is GMP sampling, specifications, testing, organisation, documentation, release procedures to ensure the necessary and relevant tests are actually carried out and that materials not released to use or products for sale and supply, until their quality judged satisfactory.
Marketing Authorisation (=Product License)
any UK medicinal product--> PL/MA on packaging
2 basic requirements to gain:
1. Dossier (dif. for new chemical entity vs generic) with evidence on safety, efficacy and quality --> MHRA
2. pharmaceutical manufacturer holds:
Manufacturer's Licence (by MHRA) AKA Manufacture's Authorisation
site inspected by MHRA to ensure safety
GMP certificate (UK contract manuf.), letter of certificate (overseas contract manuf.)
In EU alternative ways to obtain MA. A central registration for the whole EU/ rgistration in one member state and a reciprocal arrangement to allow for a simplified MA in other member states.
FDA, PFSB, TGA, EMEA=MHRA
Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors
John Sharp
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