GMP-manufacturing is the most important and decisive stage in API development.
After our synthetic chemists from the R&D Department develop and optimise the process, the Validation team from the Production Department will take over and produce the technical batch.
This means that the quality control methods are definitely ready, and that the GMP documentation (batch master records) is finalised and reviewed by the QA Department.
Then, the prevalidation will be carried out and, if this step is successful, we’ll move on to the process validation. As a result, you’ll get three validation batches of API quality with CoA.
However, the process validation is not always needed—especially for innovative molecules entering the clinical studies. In this case, we’ll prepare the GMP documentation and optimise the process (probably in gram or kilogram level) and run the GMP-manufacturing of just one batch.
The quality will still comply with the specifications and, after the CMC documentation is ready, you can start with the clinical studies.