Author: Nigel Smart

One of the outcomes from a poorly handled 483 response is that the severity of the enforcement action taken by the FDA could be escalated to the status of a Warning Letter. This sometimes happens when companies are dealing with multiple responses, where the response time by the company is inadequate, or where the responses themselves to the 483 citations are inadequate from a technical and quality standpoint. The FDA reserves the right to issue a Warning Letter any time during the processing of 483 responses, particularly if it feels that the company is not approaching the response to...

Upon inspecting your pharmaceutical facility, the FDA will issue a 483-observation report if there are inadequacies found during the inspection process. The purpose of this report, given by the FDA auditor, is to detail in writing any conditions or practices observed by them which, in their judgment, indicate that any drug in the establishment: 1. consists in whole or in part, of any filthy, putrid or decomposed substance or 2. has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. The observations...

The development of a strategy for the commissioning of facility and equipment systems to support the process development and manufacture of innovator pharmaceutical products is a complicated process that requires the input of a variety of different functional skill sets. To develop a mechanism that is functional, lean and cost-effective, it’s important to process flowchart the mechanism to ensure that all the appropriate unit operations are included and sequenced in the right order. In addition to this, by going through this process one ensures that all stakeholders functional groups are appropriately represented, their inputs are included and the consensus...

Key performance indicators (KPI’s), are very important mechanism for promoting continuous improvement in pharmaceutical quality compliance. However, in today’s world many KPI’s selected by pharmaceutical companies do little more than provide information about what is not working, rather than what elements need to be changed in order to gain a positive improvement. It’s therefore vital that KPI’s should be something (a measure), that provides information to enable improvement on a continuous basis. Failure to address this means that situations will at best remain static and more likely will regress and become more serious overtime. So, in selecting KPI’s, it...

Nigel with Chris Macklin today at the American Outsourcing Event, Crown Plaza Hotel, Cherry Hill ...