Never has the adage ‘Quality In …Quality Out’ been more apt than with the regulators' spotlight on the quality requirements for Regulatory Starting Materials (RSMs) as part of drug substances guidelines.
SAI recognised this early on and is applying in all cases the same rigour in RSM production as it does in all aspects of its integrated ‘molecular lifecycle’ value proposition.
No longer can RSM suppliers get away with a basic infrastructure. More is needed to ensure a complete understanding of not only the RSM chemistry, but also the consequences that RSM purity/impurities have on API quality, and ultimately on the regulatory submission.
Note the CDER recently issued an open letter to the pharmaceutical industry requesting feedback on quality metrics soon to be applied by the FDA to anyone supplying API to the United States.
The cost of maintaining the infrastructure that is needed to minimise RSM risk and ensure a successful API launch can be significant. When weighed against the costs of delays and product quality/health concerns, the more rigorous controls and auditing of every part of drug manufacture make a lot of sense.
The FDA notes that '…detection and eradication of impurities and the safe purging of said substances allied to perfect record keeping of all processes…' is what they are looking for.
SAI has demonstrated an ability to deliver high quality RSMs conforming to the new ICH Q11 guidelines from its cGMP and FDA inspected facility.
Innovators and API CMOs alike should be looking to RSM suppliers that don’t just have excellent understanding of Q11 and cGMP but also have demonstrated that they have already delivered against these high standards.
They should be operating with substantial analytical depth, chemistry R&D capability, a high degree of business flexibility, a mix of equipment, expertise and a culture built around quality. Extra layers of testing require reinforcing of training and strict adherence to operating procedure. This needs to be conducted against acceptable operating costs to ensure the RSM supply can be made cost effective at the same time.
SAI Life Sciences has gained significant experience in developing and supplying RSMs to many of the top 15 pharmaceutical companies, API CMOs and selected biotech innovators.
Building the SAI +1 culture within the organisation has fostered a shared ownership of projects which, when added to the overall value proposition, gives you a differentiated flexible offering.
We look forward to meeting you during CPhI and discussing the RSM implications for your projects on Stand 5J10.