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FDA Calls for Drugmakers to Take Lifecycle Approach to Analytical Methods Validation

September 18, 2015

Drugmakers making changes to analytical methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says.

They should also consider revalidating their analytical method, since changes to the manufacturing process could impact such things as route of synthesis or fermentation. The recommendations were issued July 24 in final guidance.

Details of validation studies and results should be submitted with NDAs, ANDAs and BLAs, the FDA says. Validation characteristics include specificity, linearity, accuracy, precision, range, quantitation limit and detection limit.

The final guidance, which is largely unchanged from a draft version released in February 2014, replaces a 2000 draft guidance Analytical Procedures and Methods Validation and a 1987 guidance Submitting Samples and Analytical Data for Methods Validation.

Under the guidance, each NDA or ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity and potency of the drug substance and product. BLAs must include a full description of the manufacturing methods, including analytical procedures that demonstrate the manufactured product meets prescribed standards of identity, quality, safety, purity and potency.

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