No matter where your product is in the pharmaceutical pipeline, from early formulation development to commercial production, analytical procedures will be used to ensure the identity, quality, purity and potency of the drug substance or product. As a product moves from research and development to manufacturing, it may be necessary to order an analytical method transfer of your established (validated) procedure from one laboratory to another to achieve product realization.
A general USP chapter, <1224> Transfer of Analytical Methods, outlines several types of transfers, but not to be overlooked is a section entitled “Elements Recommended for the Transfer of Analytical Procedures.” The goal of analytical method transfer is to transfer product and process knowledge between the originating and receiving laboratories, and success can be best achieved by unhindered flow of information.
Elements of Success
- Training. Experience is priceless and what better way to share specific product and method knowledge than training by lab personnel who know the characteristics of the material and the intricacies of the procedure.
- Detailed Procedures, Validation Reports, and Supporting Documentation. Information is key to understanding not only what and how to do something, but also, what sort of results to expect.
- Qualified Personnel. Teams from both sides should have the expertise in the transferring techniques to adequately share information and address issues.
- Appropriate Instrumentation and Facilities. All instruments and facility systems at the receiving unit must be properly qualified prior to transfer activities.
- Protocol. A detailed protocol outlining the objective, scope, responsibilities, experimental details, acceptance criteria and any other important expectations or considerations should be written and agreed upon between the originating and receiving unit.
A successful analytical method transfer will encompass all of the elements described above, bonded strongly by the additional critical component of shared communications between the transferring parties.
Tammy Thompson-Madsen
Latest posts by Tammy Thompson-Madsen (see all)
- 5 Elements of a Successful Analytical Method Transfer - August 26, 2013
