Method Development, Validation & Stability Studies

How can ICNE help you in your product development stages?

Method Development, Validation & Stability Studies

Our staff are experienced in method development for testing a variety of raw materials and finished products from a range of industries.

We are happy to validate methods developed in-house, client supplied methods or published methods, such as pharmacopoeia monographs. Where methods have been developed in-house, the data obtained from the validation process is then used to establish system suitability criteria for the routine application of the method.

Unless otherwise agreed with the customer, we will work in accordance with the ICH requirements: “The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. In practice, it is usually possible to design the experimental work such that the appropriate validation characteristics can be considered simultaneously to provide a sound, overall knowledge of the capabilities of the analytical procedure”.

Process Validation

Testing and validating your manufacturing processes can be time-consuming and difficult.  We can assist your QA department by testing mixer samples to your own in-house methods or our own methods, to give you meaningful and accurate results to help you assess the homogeneity of your batch samples.

Cleaning Validation

Ensuring cleanliness of your manufacturing facility is essential to prevent cross-contamination.  We can work with you to develop analytical methods capable of quantifying materials at the ppm level to prove the cleanliness and hygiene of your facility

Stability Studies

We can help confirm the long-term stability of your products by providing analytical assistance at regular time points for your developmental, or regulatory needs.  Testing can be performed to stability protocols designed for your specific product requirements, to ensure both the physical and analytical aspects of your product conform to your specifications for its entire shelf life.

Please see the document below for a current list of routine tests we offer.  Please note that if the test you are looking for is not listed within this document then please contact us as this list is not exhaustive.

Download File "ICNE 2018 Test List"

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