Written By: Mattew Greer, Technical Writer, PSC Biotech®
When bringing new products from one facility to another or from a product development to production environment , understanding the requirements for the transfer of validated analytical methods used for testing of said products is essential. It is important to compare the initial and transfer laboratories and confirm that the latter has the capability to perform the validated method correctly and consistently. The transfer needs to check that the methods adhere to the United States Pharmacopeia (USP) and any other applicable standards as well. The goal in a successful method transfer should be to reduce the number of variables in your lab which could affect the quality of the final product. These methods need to be taken from the primary lab and transcribed into approved documents for testing at the final lab. This paper will list some of the various types of method transfer possible and how PSC Biotech® can provide assistance.
Method Transfer Types
There are typically four different types of method transfers that are based on the availability of the initial testing lab as well as the complexity of the products being tested.
Comparative Testing
Comparative Testing means to test a predetermined number of samples of the same lot by both the sending and receiving facilities and comparing the results. The transfer protocol from the initial lab will determine the acceptance criteria and procedures.
Co-validation
If both the initial and transfer site needs to collaborate to complete the validation, the appropriate transfer method is to co-validate. This would mean keeping lines of communication between both sites in order to confirm the reproducibility. This strategy is optimal for dealing with multiple laboratories. Similar to the comparative testing, the protocols will come from the primary site.
Revalidation
This type of testing is necessary if the initial laboratory is not available to receive the proper methods. Revalidation is the most consuming of all the method transfers but needed when the initial lab is not accessible. Usually this work involves repeating all validation testing initially performed.
Transfer Waiver
Depending on the lab’s experience and the complexity of a method, opting for a transfer waiver is a viable option for some transfers. A risk assessment would need to be taken into consideration to confirm this approach is valid.
What Can PSC™ do for you?
Method transfer can easily become a hassle, and that is where PSC Biotech® can help. We employ a team of professional consultants who are available to transition documents with ease. Our services are offered in the form of a local team who can come onsite to collaborate to make sure your facility is ready for any type of method transfer. We can take the methods provided and generate documents that are compliant with the USP guidelines. Contact us today.
About PSC ™
PSC Biotech® offers partnership opportunities for leaders looking to advance themselves throughout the Life Sciences industry through a multitude of resources and solutions. PSC™ has served the Life Sciences industry for over twenty (20) years with exemplary professionalism, quality solutions, and client-focused services. Our goal is to provide unmatched software and hardware consulting services to Life Science companies so they can perform at their highest potential.
