Validation of analytical methods
Article 58
1. Analytical methods shall be validated unless the method employed is included in the relevant pharmacopoeia or other recognised standard reference. The suitability of all testing methods used shall be verified under actual conditions of use and this verification of suitability shall be documented. 2. The validation of the analytical methods shall be performed in accordance with the requirements set out in the guideline on validation of analytical procedures: methodology ( 6 ) . The degree of analytical validation performed shall reflect the purpose of the analysis and the stage of the active substance production process. 3. Complete records shall be maintained of any modification of a validated analytical method. Such records shall include the reason for the modification and appropriate data to verify that the modification produces results that are as accurate and reliable as the established method.