The laboratory develops, validates and issues analytical methods according the EMA and ICH guidelines for the identification and quantisation of pharmaceutical ingredients. The objective of method validation is to demonstrate, by examination, that the method is suitable for its intended purpose. The laboratory quality planning guarantees that method validation studies are carried out on optimized and adequately calibrated equipment. The analysts involved in method validation are competent in the scope, with knowledge and experience to observe and assess data in the progress of the method validation. Method validation implies performance and uncertainty evaluation.
The laboratory implements transfer method protocols on already validated methods to ensure that results generated by the sending and the receiving laboratory, on identical samples are equivalent within pre determined acceptance criteria. The project coordinator composes the analytical transfer method protocol and the laboratory manager as well as QA manager review and send the transfer method protocol for approval. Results obtained during the transfer method study are summarized on a final report.
Accelerated stability studies are designed to increase the rate of chemical degradation and/or physical change of a drug substance or drug product by using exaggerated storage conditions with the purpose of monitoring degradation reactions and predicting the shelf life under normal storage conditions. Ref: www.ich.org
For further information on method validation and transfer method services please Contact us.