Author: Nigel Smart

Today more than ever, Data Integrity has become a significant factor in being a compliant manufacture of pharmaceutical/life sciences products. Many regulatory agencies are taking a hard look at operations because of irregularities to have been unearthed during cGMP inspections and PreApproval Inspections (PAI’s). Why is this so important? Several reasons: 1. It undermines the safety/efficacy and assurance of quality that consumers have when they take these products 2. It breaks trust that the products meet specifications and have been manufactured in accordance with approved procedures 3. We’re relying on manufacturers to perform within the law and the agreements...

Laboratory compliance and efficiency can have a major impact on the success of the company to competitively manufacture and market the product. The interface between manufacturing and the QC testing environment is a critical component in this process and if there isn’t appropriate streamlining, there is a high probability that there will be a delay in the eventual release of the product for interstate/international commerce. What’s required to accomplish this is a ”hand in glove” mechanistic relationship which enables samples to be effectively analyzed according to a predictable metronome type of process. Using this approach, scheduling becomes easier and...

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...