Good pharmaceutical manufacturing practice : rationale and compliance /: rationale and compliance. (©2005)

• Record Type: Book
• Further Information: Note: John Sharp.
• Other Names: Sharp, J. R
• Contents: Introduction: status and applicability of US regulations/EU guidelines -- general quality issues -- Personnel, organization, and training -- Premises/buildings and facilities -- Contamination and contamination control -- Equipment -- Materials control -- Production and process controls -- Packaging and labeling control -- Holding and distribution -- Laboratory controls -- Records and reports -- Returned and salvaged drug products -- Sterile products manufacture -- basic principles -- GMP and quality assurance in sterile products manufacture -- Validation -- general principles -- Validation -- applications -- Self-inspection and quality audit -- US cGMPs and EC GMP guide -- concluding comparison.
• Publisher Details: Boca Raton, Fla : CRC Press
• Publication Date: 2005
• Copyright Date: 2005
• Extent: 1 online resource (ix, 503 pages), illustrations
• Subjects: 362.17/82/0973; Drugs -- Standards -- United States; Drugs -- Standards -- European Union countries; Pharmaceutical industry -- United States -- Quality control; Pharmaceutical industry -- European Union countries -- Quality control; Drugs -- Law and legislation -- United States; Drugs -- Law and legislation -- European Union countries; Drugs -- Standards -- European Union Countries; Pharmaceutical industry -- European Union Countries -- Quality control; Drugs -- Law and legislation -- European Union Countries; Médicaments -- Normes -- États-Unis; Médicaments -- Normes -- Pays de l'Union européenne; Industrie pharmaceutique -- États-Unis -- Qualité -- Contrôle; Industrie pharmaceutique -- Pays de l'Union européenne -- Qualité -- Contrôle; Médicaments -- Droit -- États-Unis; Médicaments -- Droit -- Pays de l'Union européenne; MEDICAL -- Allied Health Services -- General; Drugs -- Law and legislation; Drugs -- Standards; Pharmaceutical industry -- Quality control; Drug Industry; Legislation, Drug; Pharmaceutical Preparations -- standards; Quality Control; Europe -- European Union countries; United States; Electronic books
• Languages: English
• ISBNs: 9780203489116; 9780849319945; 0849319943
• Related ISBNs: 020348911X; 0849319943
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.