Pharmaceutical process validation. (2003)

• Record Type: Book
• Further Information: Note: Edited by Robert A. Nash, Alfred H. Wachter.
• Other Names: Berry, Ira R, 1942-; Nash, Robert A, 1930-
• Contents: Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols -- Process validation of phamaceutical ingredients -- Qualification of water and air handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic proess validation -- Harmonization GMPs, and validation.
• Publisher Details: Place of publication not identified : CRC Press
• Publication Date: 2003
• Extent: 1 online resource (776 pages)
• Subjects: 615.1/068/5; Pharmaceutical industry -- Quality control; Drugs -- Standards -- United States; Drug Evaluation -- standards; Drug Industry -- standards; Quality Control; Industria farmacéutica -- Control de calidad; Control de calidad; Industrie pharmaceutique -- Qualité -- Contrôle; Médicaments -- Normes -- États-Unis; Médicaments -- Inspection -- États-Unis; Drugs -- Standards; Pharmaceutical industry -- Quality control; Farmácia (análise); United States; United States
• Languages: English
• ISBNs: 9780203912119
• Related ISBNs: 020391211X
• 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.