A Compliance Perspective on Dissolution Method Validation for Immediate-Release Solid Oral Dosage Fo

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

Validating the automated method is the primary challenge when transferring from the manual method. A dissolution scientist must understand the potential effects from filtration, system interference, carry-over, cleaning parameters, and media replacement. Automated dissolution instrumentation can help generate good manufacturing practice (GMP) data only when validated testing parameters can negate these influences, so the dissolution scientist can be confident that results do not differ between the manual and the automated methods. In addition, all laboratory equipment used to support or generate GMP data about automated instrumentation must follow an instrument "chain of compliance." Proper documentation must exist that proves each piece of equipment has been properly qualified and calibrated for its intended use.

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