Final method development and validation

Final methods are developed for transfer to operational quality control (QC) laboratories for the release testing of production batches. Additionally, the methods are intended to be applied during Registration Stability studies and for the release of the DP or DS validation batches during the pre-approval development stage. The analytical methods should last for the entire product lifetime therefore, the aim of final method development is to generate fast, robust, reliable, and transferable HPLC methods (preferably isocratic and at low cost). 

I I Diagram illustrating the method development process for final 

Final method development should not proceed until several prerequisites are fulfilled. Specifically  

Method development samples (appropriate DS batches, formulations (active and placebo), and stability samples) are available. 

The development process starts with a thorough planning step in which a development plan is generated by the collaboration of all stakeholders, such as quality assurance (QA), QC sourcing sites, stability, development, and regulatory functions. Planning should also include information gathering to obtain  

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