Method Transfer refers to the transferring of a previously validated, non-compendial method to a different laboratory for use in testing the same sample type. Method Transfer consists of laboratory studies designed to assess the ability of a “receiving” laboratory (i.e., the lab “into which” a method is being transferred) to apply the method to obtain results which closely correlate with those generated by the “sending” laboratory (i.e., the lab “from which” the method is being transferred). Although differing strategies for conducting Method Transfer may be employed, the simplest and most common strategy is to have the “sending” and “receiving” laboratories each conduct replicate testing of the same homogenous sample, and assess the correlation of test results within each lab and between labs.
It should be noted that Method Transfer applies only to previously validated, non-compendial methods. If a compendial method is transferred into a new laboratory, this would trigger the need for conducting a Method Verification and not a Method Transfer.
CPTSM maintains state-of-the-art Analytical, Microbiological, Clinical, Photobiology and In Vitro Toxicology laboratories, all at a high level of regulatory compliance and at your immediate disposal for determining the quality, safety, stability and efficacy of your products.
CPTSM regularly conducts all types of testing in our specialized departments on a wide range of products including pharmaceuticals (OTC and Rx), medical devices, dietary supplements and personal care/cosmetics. Our in-house experts offer one-on-one guidance in selecting the most appropriate and cost-effective testing strategies for your products.
Regulated products require testing of the highest accuracy, conducted within an environment of full regulatory compliance. Because the accuracy of test results and the level of compliance under which they were generated are of equal importance to our professionals at CPTSM, just as they are to FDA and other regulatory agencies, please allow us to assist you with all of your testing needs.
Based on the individual needs of our clients, we offer a wide range of support across various departments
. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:
- Clinical —Efficacy trials can be performed for safety, consumer in-use, and to support claims, such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.’
- In-Vitro Safety — Our in-vitro safety department assists clients when they are looking to perform non-animal or animal-free toxicology testing.
- Microbiology — Microbial contamination and preservative testing is key to cosmetic products.
- Photobiology —From SPF and Water Resistant claims to PhotoAllergy and Phototoxicity studies, CPTSM is the world leader in sunscreen testing.
- Analytical — From raw materials, batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our analytical department ensures that all requirements are met based on industry standards.