Method Development and Validation 

Chemika can work with you to develop an intellectual property base to allow efficient, consistent and high quality analysis of your product. We understand that once a method has been validated and products registered based on the methods, the methods are effectively "locked in". Poorly conceived, inefficient and unreliable methods can be a major liability for a product. The sponsor of a product may have to choose between making costly changes to product registration details across a number of countries, or sticking with a method which contributes to delays in getting product to the market or results in unnecessary rework.

Before validation is commenced, the test method must be fundamentally sound and based on known principles of analytical chemistry. 

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To be used efficiently a method must be rugged, and although ruggedness is evaluated during method validation, it remains difficult to predict the behaviour of a test method years into the future and across different sites. The best way to be confident in the ruggedness of the method is to ensure that the method is based on sound science. The team at Chemika is well equipped to deliver confidence in this way.

At Chemika method validation commences with the preparation of a method validation protocol. The method validation protocol allows the stakeholders in the methodology to define the performance which is required by the method. The performance parameters need to be developed so that we know a method can be used to determine whether the product is within the specification limit. Development of validation protocols therefore requires knowledge of the product specification and release limits.

In some cases method performance requirements may exceed that needed to determine whether the product is within specification. An example of this is where trend information is required for a particular impurity. The manufacturer may wish not only to know if the impurity concentration is below the specification limit, but whether the impurity is trending towards the limit. These requirements can be discussed prior to validation and appropriate acceptance criteria included in the method validation protocol.

The reliability of method validation data is strongly influenced by the laboratories policy on exclusion of outliers and deviations during the validation process. Chemika has procedures in place which prevent uncontrolled rejection of outliers. Treatment of outliers can have a profound influence on the conclusions of a validation report. Uncontrolled treatment of outliers can mean the validation report will not accurately represent the performance of the test method.

We look forward to hearing from you. Please contact us now to discuss your analytical requirements.