Changing Global Regulatory Compliance and its Impact in Asia

It is no secret that the biopharma industry in general produces a lot of paper documentation.  The industry, understandably it would have to be said, is one of the most regualted industry in the world, with good reason. This is as in no other industry where human lives depend very much on the safety and reliability of the products that are manufactured.Therefore to ensure that a high level of safety of the products on offer,  a huge amount of documentation is needed to satisfy the various regultory bodies.

At one of the Technological on-floor Seminar held during the BioPharma Asia convention, it was revealed by Warren Perry from QUMAS that the FDA now requires all documentation for regulatory approval to be submuited to them electronically. This is inline to make sure that the auditing procedures can be easily undertaken and no problems relating to for example language differences will crop up down the line. While many would agree that Asia’s rise would mean that the future of biopharma lies in the East, currently and for the forseable future FDA aproval would be needed for any new products.

Thus QUMAS, allows for any companies to easily comply with the FDA requirement to electronic documentations. Their processes comply to global standards notably that of the recently established PIC/s. This rigourous process is not one which is easily attainaable as is require many number of years of auditing and inspections before the standard can be achieve. Therefore  any company not just Asian biopharma firms need to look at global trends in compliance regulations in order to ensure that their products will be approved for use and sale in majore markets of the world.

Leave a Reply

Your email address will not be published. Required fields are marked *