Good Laboratory and Manufacturing Practice, and ISO 17025 require that all analytical methods used for testing are suitable for their intended purpose and are capable of delivering accurate, precise and reliable results.
Analytical method validation is documented evidence that demonstrates an analytical procedure will consistently produce results that meet predetermined quality characteristics.
Validation of analytical methods not only applies to methods that have been developed in house, it is also necessary to demonstrate that any official method used in the laboratory can meet required quality criteria.
Proper validation of analytical test methods is of fundamental importance in order to ensure the results created are reliable and trustworthy. It is also of critical importance that the method instructions are written in such a way to ensure that there is no possibility for misinterpretation or misunderstanding.
Having third party input into the method validation life cycle can often identify ambiguities and potential for misunderstandings and misinterpretations that might otherwise be missed, only to come back to haunt the laboratory in the future.
We can help your laboratory validate your analytical methods according to ICH Q2 guidelines1, including developing:
Standard Operating Procedures for test method validation, including
Methods developed in-house
Methods transferred from another laboratory
Protocols for the validation of analytical test methods, including creating and justifying acceptance specifications for:
Strength/potency, content uniformity and blend homogeneity methods
Absence of/placebo methods
Cleaning validation methods
Stability indicating methods
Protocols for transferring methods between laboratories