Test Methods And Method Validation

General

The scope of test technologies and associated method source routinely used are identified in the laboratory’s accreditation program documentation.

The estimation of the uncertainty of measurement and  Assuring the Quality of Test Results of this manual shall be describes the quality control processes, including the application of statistical techniques, for supporting test and calibration data.

The laboratory instructions for the use and operation of equipment called for by the laboratory methods is either a laboratory procedure identified on the master list or as equipment manuals. 

Selection of Methods

Standard methods are those published by international, regional or national standards-writing bodies; by reputable technical organizations; in legal references; and FDA published methods. FDA “official” methods are those in compendia specified in the FD&C Act and prescribed in the CFR and methods in applications and petitions that have official status are included. These methods include those in the United States Pharmacopeia, National Formulary, Homeopathic Pharmacopeia of the United States, Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC) International or any supplement of any of them, American Public Health Association (APHA) Compendium of Methods for the Microbiological Examination of Foods, FDA compliance programs, the Pesticide Analytical Manual (PAM), the Food Additives Analytical Manual, the Food Chemicals Codex, FDA Bacteriological Analytical Manual (BAM), FDA Macroanalytical Procedures Manual (MPM), and ORA Laboratory Information Bulletins (LIBs) that are included in compliance programs and special assignments. Standard methods are preferred for use and are verified for use in the laboratory. A standard method may be supplemented with additional details in the form of a laboratory procedure to ensure consistent application. Those methods specified by the manufacturer of the equipment are considered as standard methods. Standard methods are verified according to the procedure,  Methods, Method Verification and Validation.

 Laboratory Developed Methods

If a laboratory develops methods for its own use, the laboratory has its own procedure for its introduction. This procedure provides the planned activities, identification of qualified personnel, and resources. Plans are revised as method development proceeds and effective communication amongst all personnel involved is strongly encouraged. Laboratory developed methods adopted by the laboratory are used if they are validated according to validation of Methods.