The key change is that GMP inspection outcomes will become publicly visible, rather than remaining information communicated primarily between the TGA and the inspected manufacturer.
The TGA licence is ultimately evidence that the manufacturing site has met the applicable regulatory requirements for the authorised scope.
Quality Systems Now provides GMP consulting support to organisations that need to establish, strengthen, assess or maintain compliant quality systems. Our work focuses on practical implementation
The transition from R&D to GMP does not need to represent a conflict between innovation and compliance. The most successful organisations recognise that quality systems support scientific progress.