Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm

In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International...

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Bibliographic Details
Published in:	AAPS PharmSciTech Vol. 15; no. 3; pp. 665 - 693
Main Authors:	Van Buskirk, Glenn A., Asotra, Satish, Balducci, Christopher, Basu, Prabir, DiDonato, Gerald, Dorantes, Angelica, Eickhoff, W. Mark, Ghosh, Tapash, González, Mario A., Henry, Theresa, Howard, Matthew, Kamm, Jason, Laurenz, Steven, MacKenzie, Ryan, Mannion, Richard, Noonan, Patrick K., Ocheltree, Terrance, Pai, Umesh, Poska, Richard P., Putnam, Michael L., Raghavan, Ramani R., Ruegger, Colleen, Sánchez, Eric, Shah, Vinod P., Shao, Zezhi Jesse, Somma, Russell, Tammara, Vijay, Thombre, Avinash G., Thompson, Bruce, Timko, Robert J., Upadrashta, Satyam, Vaithiyalingam, Sivakumar
Format:	Journal Article
Language:	English
Published:	Boston Springer US 01-06-2014
Subjects:	Animals Benchmarking - standards Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Chemistry, Pharmaceutical - standards Delayed-Action Preparations - standards Drug Approval Drug Industry - methods Drug Industry - standards Excipients - chemistry Excipients - standards Humans Pharmaceutical Preparations - administration & dosage Pharmaceutical Preparations - chemistry Pharmaceutical Preparations - standards Pharmacokinetics Pharmacology/Toxicology Pharmacy Quality Control Risk Assessment Solubility Technology, Pharmaceutical - methods Technology, Pharmaceutical - standards Toxicology - standards United States United States Food and Drug Administration White Paper United States CMC PAT QbD IVIVC ICH
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Summary:	In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro – in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	1530-9932 1530-9932
DOI:	10.1208/s12249-014-0087-x