Up-to-date overview, hot topics and rational quality manager tutorial pdf. The Laboratory compliance package includes 31 SOPs. Some of them are shown here.
Ludwig Huber Frequent speaker and chair person at FDA, ISPE, PDA, USP. A large portion of this tutorial comes from the book: Validation and qualification in Analytical Laboratories, published by Informa in 2007. For contents and ordering, click here. Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use.
Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with Sec. These requirements include a statement of each method used in testing the sample to meet proper standards of accuracy and reliability, as applied to the tested product.
The document includes definitions for eight validation characteristics. The AOAC, the EPA and other scientific organizations provide methods that are validated through multi-laboratory studies. Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods. Peer-Verified Methods validation program with detailed guidelines on exactly which parameters should be validated.
This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation. It also describes what is important when transferring a method. The validity of a specific method should be demonstrated in laboratory experiments using samples or standards that are similar to unknown samples analyzed routinely. The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format. Possible steps for a complete method validation are listed in Table 1. This proposed procedure assumes that the instrument has been selected and the method has been developed.