GMP compliance, productivity, and quality : achieving synergy in healthcare manufacturing / [edited by] Vinay Bhatt.
Contributor(s): Bhatt, Vinay
.
Material type: 
BookPublisher: Buffalo Grove, Ill. : Interpharm Press, c1998Description: xxxi, 492 p. : ill. ; 27 cm + hbk.ISBN: 1574910779.Subject(s): Pharmaceutical technology | Pharmaceutical industry -- Quality controlDDC classification: 615.19
| Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|
| General Lending | MTU Bishopstown Library Store Item | 615.19 (Browse shelf(Opens below)) | 1 | Available | 00082331 |
Enhanced descriptions from Syndetics:
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
Includes bibliographical references and index.
CIT Module BIOT 7004 - Core reading.
CIT Module BIOT 8002 - Core reading.
Table of contents provided by Syndetics
- Process Improvement & GMP Compliance
- Pharmaceutical Development
- Process & Equipment Optimization
- Facilities & Support Systems Optimization
- SUPAC & Regulatory Consequences
- Laboratory Operation
- Validation
- Integrated Supply Chain Planning
- Outsourcing
- Inspection of Automated Systems
- PAI Preparation
- Regulations, Harmonization, & the Industry
- Pharmaceutical Quality