Discussion and Summary
Process development report contains various information that is vital and should always be included in the process development group. Some of the most important information include; summary of the overall process development, drug substance CQAs, the history of the manufacturing process and manufacturing development studies. The information provided in the process development report should be able to highlight significant changes during the development process (Agalloco and Frederick 453). Additionally, the information should relate pertinent drug substance batches with the various stages of development of the control strategy and manufacturing process employed in making them. It is also imperative that the information can elaborate how previous risk assessment, knowledge and other studies were applied to determine the significant aspects of the control strategy and manufacturing process.
It is significant that development process report commences with a summary of the overall process development. The overall process development summary outlines the significant narrative in the development process (Agalloco and Frederick 453). This section provides vital information on the relationship between milestones and guaranteeing that the expected quality of drug substance is attained. The overall summary should include the following information: drug substance CQAs list; a short description of the stages of the transformation of the process development process and pertinent alterations to the control methodology; brief explanation of the improvement of any design spaces, short elaboration of the substance characteristics and process parameters highlighted as having an effect on drug substance CQAs.
Works Cited
Agalloco, James P, and Frederick J Carleton. Validation Of Pharmaceutical Processes. New
York: Informa Healthcare, 2008. Print.
