Identifying Process Validation Issues

In advance of our completely-updated course Process Validation for Drugs and Biologics, we have asked all participants to prepare examples of FDA process validation concerns and issues they have in their own companies for discussion in the session. If you are new to the business or otherwise unsure how to identify issues, we’d like to offer some pointers to make your attendance at the session as impactful as possible, and also help all pharmaceutical professionals identify process validation compliance concerns that may sideline the development of drugs and/or incur costly audits and drug recalls by the FDA.

At the outset, one of the most important things a firm can do for process validation is to develop and maintain a written testing program that describes stability characteristics and procedures for stability testing throughout the lifecycle of drug development. Such a process ensures that all drugs produced in your laboratory are consistent in strength, half-life, etc. but perhaps, more importantly, ensures that microbial contamination or spoilage are not present in any batches of product. It is the responsibility of senior leadership to ensure all employees of the lab act in accordance with the stability testing program, which is why the Process Validation for Drugs and Biologics course is geared towards both management and staff-level employees to keep everyone in your organization working towards the same goals.

Additionally, the three-step design of process validation is designed by the FDA to guarantee that procedures, when properly followed, will produce consistency in the performance of your drugs or biologics, the end result of which is consumer loyalty, both by the public and physician partners. Ultimately, process validation is not merely a safety concern - It keeps your product reliable, which makes the work of your marketing and sales departments much easier, resulting in higher quality products. Avoiding the obstacle of an FDA audit is a low bar for most businesses operating in our country - the ultimate goal of an excellent process validation system is ensuring your products are the best on the market in quality and in sales.