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Title: Toward higher QA: From parametric release of sterile parenteral products to PAT for other pharmaceutical dosage forms
Authors: Hock, S.C.
Constance, N.X.R.
Wah, C.L. 
Keywords: Current regulatory status
Parametric release
Pharmaceutical dosage forms
Quality assurance
Issue Date: Jul-2012
Citation: Hock, S.C.,Constance, N.X.R.,Wah, C.L. (2012-07). Toward higher QA: From parametric release of sterile parenteral products to PAT for other pharmaceutical dosage forms. PDA Journal of Pharmaceutical Science and Technology 66 (4) : 371-391. ScholarBank@NUS Repository.
Abstract: Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach for determining the pharmaceutical quality of the finished dosage form. In the case of terminally sterilized parenteral products, the limitations of conventional batch testing have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms, beyond terminally sterilized parenteral products. For parametric release to be possible, manufacturers must be capable of designing quality into the product, monitoring the manufacturing processes, and controlling the quality of intermediates and finished products in real-time. Process analytical technology (PAT) has been thought to be capable of contributing to these prerequisites. It is believed that the appropriate use of PAT tools can eventually lead to the possibility of real-time release of other pharmaceutical dosage forms, by-passing the need for end-product batch testing. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. Last but not least, current regulations governing the use of PAT and the manufacturing challenges associated with PAT implementation are also discussed. ©PDA, Inc. 2012.
Source Title: PDA Journal of Pharmaceutical Science and Technology
ISSN: 10797440
DOI: 10.5731/pdajpst.2012.00873
Appears in Collections:Staff Publications

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