What Is Shelf Life Testing Of A Pharmaceutical Product?

Posted by Michelle Puglielli

Shelf-life testing of a drug product is a means of assessing the functionality, effectiveness, and stability of a pharmaceutical product over a period of time to either establish a new expiry date for a new product, or to collect data in ongoing support of an already-existing expiry date for a commercial/marketed product.

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Topics: Quality Control Testing

What Is Involved In An Analytical Method Transfer For Pharmaceutical Products?

Posted by Dragan Pupovac

The analytical method transfer is regulatory requirement number one. Performed between two companies' testing laboratories -- or it might be even one company with two different sites, or with two laboratories within one company -- the analytical method transfer is a documented process designed to verify a certain laboratory’s capability of performing the analytical testing method’s intended use. Analytical method transfers are performed for validated methods for which complete analytical methods and validation data are available.

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Topics: Quality Control Testing