Method Development and Validation
We are experienced in developing methods to allow for analysis of products and materials using a wide variety of analytical techniques, and proceeding to validation according to protocols meeting the requirements of Australian and international regulators.
The development of new methods, modification of test methods or verification of compendial and supplied methods are completed thoroughly and efficiently at Chemika. Methods which are fundamentally sound allow for ease of validation and trouble free implementation over many years and across different sites. Such methods are most likely to be accepted by regulators. Staff at Chemika are experienced in testing a wide variety of active and excipient molecules using a very wide variety of techniques.
We are able to develop protocols in collaboration with our customers so that the method is challenged and capable of performing the intended task. Protocols reflect the way the test results are to be used, and can be brief or comprehensive depending on the requirements of the customers and the application of the test method.
Validation work can be completed to comply with the requirements of a variety of regulators, with the following guidance documents used routinely:
|Guidance Document:||Regulatory Authority:|
|ICH Q2 (R1) Validation of analytical procedures: text and methodology.||Australian TGA, PIC/S participating authorities.|
|Analytical Procedures and Methods Validation for Drugs and Biologics. Guidance for Industry, 2015 Pharmaceutical Quality/CMC (USA)||US FDA|
|Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical Products, 2004, APVMA||APVMA|
Our projects team utilises project management tools to ensure that a number of projects can be managed simultaneously so that validation work is completed in a timely manner.