1. General Requirements

1.1.          Validation of an analytical or microbiological method is the process by which it is established by Laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications.  Methods must be re-validated if conditions are changed significantly.

1.2.          New and revised analytical and microbiological methods are supported by sufficient Laboratory data to document the validity of these procedures.  The Technical Department is responsible for ensuring that analytical and microbiological testing methods comply with the validated procedures and have been approved by the relevant authorities, before being released into either Laboratory.

1.3.          Ideally a method should be based on established techniques requiring commonly available equipment with the greatest selectivity.

1.4.          The validation evaluation includes the assessment of the clarity and completeness of the description of the method, the determination of the need for the method and documentation that the methods have been appropriately validated.  It is essential to establish that analytical procedures produce data that are sufficiently accurate and precise for their intended purpose.

1.5.          Revised procedures should compare the limitations of the current assay and the advantages offered by the proposed method.

1.6.          All analytical procedures must be validated prior to generating data that is intended for regulatory submissions or that are used to test finished products, raw materials or packaging components.

1.7.          Cleaning processes are validated to the degree appropriate to their intended use.

1.8.          Analytical and Microbiological Method Validation should:

1.9.          The proposal should contain a complete description of the method in sufficient detail so a technician may replicate it with ease.

1.10.             Thorough and complete documentation of the method validation should be provided. The documentation should include summaries of experimental data and calculations substantiating each of the applicable analytical performance parameters.

1.11.             Performance characteristics are expressed in terms of analytical parameters: accuracy, precision, specificity, limit of detection, limit of quantitation, robustness, linearity and range and apply to both Biological and Chemical assays.

1.12.             It is unrealistic to apply the same acceptance criteria to a Biological assay and microbial evaluations as is applied to Chemical testing since by their very nature biological systems contain inherent variability.  It is not possible to define and control all the key factors that affect the assays.  Microbiological validation must be supported by good assay design, the elimination of systematic bias in the assay and proper analysis and validity testing.  The source of the test method should be noted in the validation documentation.

1.13.             Microbiological test methods should address the following limitations during validation:

2. Assay Categories

2.1.          Category I

2.2.          Category II

2.3.          Category III

3. Data Elements Required for Assay Validation
4. Analytical Performance Parameters

4.1.          Accuracy

4.2.          Precision

4.3.          Specificity

4.4.          Limit of Detection

4.5.          Limit of Quantitation

4.6.          Linearity and Range

4.7.          Robustness

5. System Suitability Testing
6. Reference Standards