Method Development and Validation
STERIS Laboratories offers method development and validation for pharmaceuticals, medical devices and related industries
Method development and validation are essential in drug development and manufacture. Once a method has been developed, it is a key requirement to prove that the method is suitable for its intended use. A validation is performed to verify the method’s suitability and, if successful, the method is deemed valid to use for its purpose.
Method development and validation can be a complex story, and STERIS Laboratories has systematic procedures to guide our Customers through the process. Our team is experienced in developing methods for drug products, APIs and excipients, as well as healthcare products and cosmetics.
Our cGMP laboratories are equipped to perform method development and validation studies. Additionally, STERIS Laboratories performs forced degradation studies including acid, base, peroxide, light and temperature. A forced degradation study is an essential tool in developing stability indicating methods.
After a successful method development, the suitability of the method should be verified with a method validation. STERIS Laboratories performs method validation studies in accordance with ICH guidelines. Before we begin a validation, we edit a method validation protocol, which is shared with our Customer for approval. Once the validation is approved, we begin the study and the following parameters are tested regularly: specificity, limits of detection and quantification, linearity, accuracy, precision and robustness. Upon completion, all results are presented to the Customer in a validation report.
Additionally, STERIS Laboratories offers cleaning validations. Cleaning validations are of high importance in the manufacturing and packaging of pharmaceutical products.
Method development validation is used for:
- Medical devices