Our staff are experienced at developing methods for testing drug products, APIs, impurities and excipients for the Pharmaceutical Industry. In addition these same skills can also be applied for medical device, health and beauty care and fine chemical manufacturers, as well as a variety of other industries.
We have the facilities to undertake stress testing as outlined in the relevant ICH guidelines for the development of stability indicating methods. We are also 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".
The uncertainty of measurement is also calculated as required by ISO 17025: “Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The validation shall be extensive as is necessary to meet the needs of the given application”.
For more information on our method development and validation services you can get in touch using our contact form.