By: Costas Chantzis

Costas Chantzis — Mon, 20 Oct 2008 16:24:48 +0000

The FDA has a responsibility to protect the interests of the public. My 30 years of experience with numerous remediation consent decree, warning letter, 483’s projects indicates the end product of the FDA’s new product submission review and actual site inspection activities is VARIED quality due to the varied quality of its work force. The medical device industry seems to be ahead as compared to pharma in relation to regulatory compliance and overall productivity. The pharmaceutical, medical device and overall healthcare industries continue to look for creative ways to deliver bottom line results to their stockholders EVERY quarter by doing the ABSOLUTE minimum relative to FDA compliance. The success formula – solution to this challenge is simple yet VERY difficult to implement, especially for very large size companies: Understand your customer needs; design and prove feasibility of a product that could satisfy those needs; develop and validate a bench manufacturing process that could produce a product of consistent quality; transfer PROPERLY the already well-understood and documented technology, etc. to manufacturing; launch the product; continuously improve the product based on a ROBUST change control, CAPA, and overall Quality System, and the bottom line issue will take care of itself. Lots of companies don’t understand how their products are being manufactured; what are their CPPs, CQAs; have inept change controls, CAPAs and Quality Systems, and then they wonder why they got problems … Companies need to go past the various buss words of every year and instead focus on the CORE issues that guarantee to produce for their stockholders significant and quantifiable bottom line benefits now and in the future. This is not utopia; it can be done with the right strategy, correct identification of current root causes and then proper implementation of a fast and effective, regulatory compliant action plan.

By: José Ascensão

José Ascensão — Tue, 30 Sep 2008 17:49:13 +0000

Actually, one should measure and control CPPs in order to obtain good quality product. CQAs are a much broader concept that includes caracteristics of the final product as well as RM attributes or IPC’s, for example.
But I agree that PAT or even QbD shouldn’t be used as an excuse to expect less FDA oversight.

Comments on: PAT and QbD Have Many Benefits, but Don’t Bank on Regulatory Relief

By: Costas Chantzis

By: José Ascensão