This is a very complex task, which generally includes the following aspects:
Product investigation and positioning: a good product, promising products to ensure the future of sustained profitability
Product research and development: R & D tests, small trials, pilot tests to determine the basic maturity of the process
The new factory design and construction: to find the relevant qualifications of the local design Factory, factory design should be forward-looking, on the one hand, the hardware layout should be forward-looking, GMP compliance should also be forward-looking
Equipment installation and validation: this stage is very important, but also the focus of the GMP audit of new factories, to confirm that the equipment is able to meet the process requirements and GMP requirements.
Trial production and process validation: After the equipment confirmation is completed, trial production and process validation can basically be carried out in accordance with the originally developed process.
Drug registration: If the drug has been registered, then this step is simple, if not yet registered, then you also need to use the process validation of the production of three batches of product data submitted for registration.
Apply for GMP certification: when you get the registration number you can apply for GMP certification.
For the new plant GMP certification, need to focus on the preparation of the process consistency, cross-contamination issues, personnel training aspects of the problem, equipment to confirm the completeness.