3 Steps To A Successful Analytical Method Transfer Of Your Solid Oral Dosage Form

By John Frankonis, Laboratory Director, Ropack Pharma Solutions The analytical testing of intermediate and finished drug products is a critical part of the drug development process, as it is essential to ensuring the safety and efficacy of the final product. For a variety of reasons, testing often shifts to another site within the company or even outside the company to a contract manufacturing organization (CMO).  If the products need to be tested and released at another facility, FDA guidance states the method needs to be officially transferred to the new location, where similar analytical results need to be generated. The originator laboratory can avoid lengthy delays by drafting an analytical method transfer that ensures the receiving laboratory possesses and demonstrates the capability, knowledge, and consistency to test the material as intended. The following steps will help guide the process of completing a successful analytical method transfer. By adhering to them, both laboratories can avoid common missteps, thereby removing any barriers to progressing the drug to the next phase in its development and commercialization.
Source: Pharmaceutical Online News - Category: Pharmaceuticals Source Type: news