What is a method validation? Should my method be verified? What scope of testing should be included in my method transfer? These are just some of your questions. Let Particle Technology Labs help with the answers.
PTL is pleased to offer method validation, method verification, and method transfer services governed by industry standards as you prepare your submission to regulatory bodies such as FDA. As stated in the FDA Guidance for Industry “Analytical Procedures and Methods Validation for Drugs and Biologics” dated July 2015, analytical method validation is defined as “the process of demonstrating that an analytical procedure is suitable for its intended purpose.” FDA Guidance for Industry is a self-stated complement to “International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology,” which is in turn harmonized “to the extent possible” with USP <1225> “Validation of Compendial Procedures”.
As stated in USP <1226> “Verification of Compendial Procedures,” verification is recommended for procedures being “performed for the first time” to show they “yield acceptable results utilizing the personnel, equipment, and reagents available.”
As stated in USP <1224> “Transfer of Analytical Procedures,” method transfer is a documented process to ensure a lab can conduct a newly introduced procedure with “the procedural knowledge and ability to perform the transferred analytical procedure as intended.” Method transfer may be conducted to show comparative testing, covalidation between two or more laboratories, or revalidation and ensures consistency. In the case of a method change due to an instrument retirement, PTL offers protocol-driven method transfer with repeat testing.
When you request one of these services, a methods specialist will work with you during the entire process from protocol development to report sign-off, ensuring your approval is sought throughout. PTL’s rigorously trained chemists will use cGMP qualified instrumentation per USP <1058> to conduct the work. Once concluded, a comprehensive report package is released which thoroughly summarizes the method study performed, the results achieved, as well as other supporting documentation.
The majority of the analyses conducted at PTL (including particle size and surface area) fall into Category III as defined by USP<1225>. Category III procedures require the evaluation of precision during validation. Other parameters may be required depending on the method and goals of the client. PTL typically suggests evaluating accuracy by reference material analysis and microscopy digital image capture of the test material, robustness by design of experiments, method precision (repeatability), and intermediate precision (comparison of chemists and/or days and/or instruments, as resources allow). We defer to your needs for the final decision.
By Rebecca Lea Wolfrom – Technical Compliance Manager
