The Good manufacturing practices (GMP) are guidelines that pharmaceutical agencies require to companies that manufacture pharmaceuticals. In particular, the pharmaceutical industry of the European Union maintains high standards of Quality Management in the development, manufacture and control of medicinal products.
Manufacturing authorisations are required by all pharmaceutical manufacturers in the European Union whether the products are sold within or outside of the Union.
Complying with GMP means ensuring proper quality standards in every phase of the production.
Biore helps you comply with GMP guidelines and obtain the necessary authorisations for manufacturing pharmaceuticals. In particular, we are able to provide our customers with:
- Batch Records
- Standard Operating Procedures (SOPs)s for relevant processes:
- Validation procedures including media fills;
- Qualification procedures of machinery and main services: WFI, PW, HVAC, autoclaves, tunnels and filling
- Cleaning Validation procedures.