US FDA to make QbD document mandatory for exporters from January 2013.

The US Food and Drug Administration (FDA) is planning to make the submission of Quality by Design (QbD) document mandatory for all the NDA applicants from January 2013. All the manufacturers exporting to the US, will now have to submit an entire set of documents supporting their product, right from its inception stage to the US regulatory authority while filing for approval.

The documents submitted should support the companies claim on how effective and efficacious their product is from the design stage itself. Failing  which there are chances of their application being rejected by the FDA officials.

QbD is a concept that is introduced by the US FDA with an aim to understand the design and development of the pharmaceutical formulations and manufacturing processes to help ensure quality of the end product.

On this occasion, the International Pharmaceutical Excipients Council (IPEC) has urged all the Indian manufacturers exporting to the US to update and prepare themselves on the procedural requirements so that they will not be taken by surprise while filing any NDA applications.

IPEC with the help of the experts from the industry, have been conducting many seminars and events to sensitise and inform the industry about QbD. The council wants the Indian exporters to be well informed about the procedure that needs to be followed while submitting NDA application to avoid rejection.

David R Schoneker, global co-ordinator of IPEC Federation said, “Timing is very essential, thus creating awareness about QbD among the Indian exporters right now, is of utmost importance as it will help in getting the word around in the industry beforehand, preparing them for the implementation in advance. Right now, very few in the industry have any clue about what QbD is and what its impact will be on the companies and their exports if they fail to follow it when the time comes.”

IPEC team has been working with experts on these issues and are playing an important role in informing the companies on this subject. The council is at present working on increasing awareness for developing a level of understanding of this regulatory concept among the industry.

“India is one of the leading exporters to the US and therefore to ensure undisrupted and smooth functioning of the business between the two countries, it is essential to keep the Indian exporters in loop of all the impending activities planned by the US FDA. This will give the Indian counterparts sufficient time to prepare themselves for the change and adopt it accordingly without affecting the business in the process,” Schoneker added.

He further stressed that there is need to initiate more such initiatives as most of the Indian companies exporting to the US are unfortunately are not well tuned into the activities of the US FDA which later can cause confusion and delay in overall services.

Source : pharmabiz.com