Validation and approach towards analytical Methodology
Pharmaceutical manufacturing process knowledge depends on accurate and precise measuring techniques used to test and examine the quality of drug components, in-process materials, and finished drug products. Validated analytical methods are not necessarily required during product- and process-development activities or when used in characterization studies and during process validation. Nevertheless, analytical methods should be scientifically sound (e.g., specific, sensitive, and accurate) and provide results that are reliable. There should be assurance of proper equipment function for laboratory experiments. Procedures for analytical method and equipment maintenance, documentation practices, and calibration practices supporting process-development efforts should be documented or described. New analytical technology and modifications to existing technology are continually being developed and can be used to characterize the process or the product. Use of these methods is particularly appropriate when they reduce risk by providing greater understanding or control of product quality and for process validation. However, analytical methods supporting commercial batch release must follow CGMPs in parts 210 and Part 211. Clinical supply production should follow the CGMPs appropriate for the particular phase of clinical studies.
Process Validation Series
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