Quality systems and control for pharmaceuticals / Dipak K. Sarker.
Material type: TextPublication details: Oxford : Wiley-Blackwell, 2008.Description: 216 pISBN:- 9780470056929 (hbk.) :
- 9780470056936 (pbk.) :
- 9780470056929
- 338.476151 SAR
- RS189 .S27 2008
Item type | Current library | Call number | Copy number | Status | Date due | Barcode | |
---|---|---|---|---|---|---|---|
Long Loan | TUS: Midlands, Main Library Athlone General Lending | 338.476151 SAR (Browse shelf(Opens below)) | 1 | Available | 207793 |
Includes bibliographical references and index.
Technology transfer and the climate of change -- Quality systems structure and a maximum quality environment -- Validation -- Good manufacturing practices -- Process control via numerical means -- Product verification and the role of qualified personnel -- In-process and on-process QC testing and control -- Applications of QA to new medicinal products and new chemical entities formulation -- New products manufacturing -- Questions and problems -- References.
In the global marketplace, particular problems can arise when limited control is exercised over new and high-risk medicines. Providing a multidisciplinary approach, this book provides a comprehensive overview of the highly regulated area of pharmaceutical manufacture.