Compliance testing during production

This study was made at the Thomas A. Allen Steam Plant in Memphis, Tennessee, which has an 870 MW(e) peak capacity from three similar cyclone fed boilers. The plant is part of the TVA power system and was chosen because the Number 2 unit was being renovated. A new Lodge Cottrell electrostatic precipitator was being added so the TVA Power Production Division test sampling crew were available to help sample during compliance testing of the precipitator. 

There are many reasons why quality measurements are needed. Products must be tested for compliance and content, for safety, and to meet a variety of regulations. Quality measurements are also needed to monitor quality during production and in process control. Contracts are written based on standards and terms of procurement that must be tested. Every day, regulatory agencies make decisions based on results which are only as good as the quality of the methods upon which they themselves are based. Quality measurements support international and national trade and support research. Laboratories need to generate credible data and to do so they must have valid methods. 

The process of method development and validation covers all aspects of the analytical procedure and the best way to minimize method problems is to perform validation experiments during development. To perform validation studies, the approach should be viewed with the understanding that validation requirements are continually changing and vary widely, depending on the type of product under test and compliance with any necessary regulatory group. 

Numerous specifications and control measures are employed to determine final product quality, the first of which is ensuring adequate quality of excipients and active ingredients. Excipient testing ensures compliance with compendial specifications, as well as specifications determined during development of the fill material and/ or shell formulation. Among these are limiting values for trace impurities, especially peroxides, aldehydes, some metals, and ionic salts. 

It will check for equivalence, for both the drug substance and pharmaceutical product, between that used in the pivotal clinical studies, the pivotal stability studies and commercial production. This is usually achieved by inspecting product and control data such as clinical trial batch records, in-process and end-product test results and raw material, component and product specifications. During an R D PAI the FDA will also check for general compliance with cGMP, will inspect the facilities and equipment used and check the appropriateness of control systems and procedures. 

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