Quality (Pharmaceutical Engineering Series)Butterworth-Heinemann, 2002 M09 24 - 275 pages The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership.
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activities application appropriate approved areas aspects audit bacteria batch of product biofilm calibration carried chapter clause cleaning clinical trials closure compliance containers cost of quality countries covered discussed distribution document drug effective electrodeionization endotoxins ensure equipment EudraNet example facility factory filters finished product guidelines Hence identified important inspection inspectors instrument issue labelling laboratory manufacturing practice marketing authorization measures medicinal products microbiological monitoring necessary number of different operation organization packaging materials Pareto chart particular personnel pharmaceutical industry pharmacovigilance PIC/S problems procedures product recall programme purified water quality assurance quality control quality improvement quality management quality system recall records regulatory authorities relating release requirements responsibility role sampling sanitization self-inspection specific stage standards sterilization storage supplier tank temperature testing total quality management types validation whilst
Popular passages
Page 260 - January 1965 on the approximation of provisions laid down by law, regulation, or administrative action relating to proprietary medicinal products as extended, widened, and amended.
Page 261 - Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use.