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Quality in the manufacture of medicines and other healthcare products / John Sharp.

By: Material type: TextTextPublication details: London : Pharmaceutical Press, 2000.Description: xi, 516 p. : ill., forms ; 25 cmISBN:
  • 9780853694311 (hbk.) :
  • 0853694311
Subject(s): DDC classification:
  • 615.19 SHA
LOC classification:
  • RS403
Contents:
1.Applications and definitions -- 2.The cocept of quality -- 3.The regulatory factor: background -- 4.QC. QA and GMP: their nature and inter-relationships -- 5.The essentials of GMP: UK/EC and USA GMPs compared -- 6.Quality assuranc beyond GMP: the wider aspects and the cost of quality -- 7.The quality movement, \'quality gurus\', TQM and ISO 9000 -- Part two.Premises and equipment -- 8.Premises and contamination control -- 9.Premises: locaiton, desing, structure, layout, services and clearning -- 10.Equipment -- Part three. Personnel -- 11.Personnel management -- 12.Training -- 13.Personnel: hygiene and health -- Part four: Documentioant -- 14.Documentation: general -- 15.Documentation in action -- Part five.Quality control -- 16.Quality control and good control laboratory practice (GCLP) -- 17.Analytical validation -- 18.Laboratory documentation and records -- Part six. Sterile and other products -- 19.Sterile products: basic concepts and principles -- 20.Assurance of quality in the manufacture of sterile products -- 21.Non-sterile manufacture and packaging -- Part seven. Validation -- 22.Validation: concepts, principles and terminology -- 23.Validation: applications -- Part eight.Self-inspection/quality audit and other techniques -- 24.Self-inspection and quality audit -- 25.SPC, HACCp and other techniques.
Summary: This overview of quality assurance in pharmaceutical production describes the principles and practice, and discusses specific quality issues, providing a guide to both national and internatinal regulatory requirements.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 615.19 SHA (Browse shelf(Opens below)) 1 Available 120063

Includes bibliographical references and index.

1.Applications and definitions -- 2.The cocept of quality -- 3.The regulatory factor: background -- 4.QC. QA and GMP: their nature and inter-relationships -- 5.The essentials of GMP: UK/EC and USA GMPs compared -- 6.Quality assuranc beyond GMP: the wider aspects and the cost of quality -- 7.The quality movement, \'quality gurus\', TQM and ISO 9000 -- Part two.Premises and equipment -- 8.Premises and contamination control -- 9.Premises: locaiton, desing, structure, layout, services and clearning -- 10.Equipment -- Part three. Personnel -- 11.Personnel management -- 12.Training -- 13.Personnel: hygiene and health -- Part four: Documentioant -- 14.Documentation: general -- 15.Documentation in action -- Part five.Quality control -- 16.Quality control and good control laboratory practice (GCLP) -- 17.Analytical validation -- 18.Laboratory documentation and records -- Part six. Sterile and other products -- 19.Sterile products: basic concepts and principles -- 20.Assurance of quality in the manufacture of sterile products -- 21.Non-sterile manufacture and packaging -- Part seven. Validation -- 22.Validation: concepts, principles and terminology -- 23.Validation: applications -- Part eight.Self-inspection/quality audit and other techniques -- 24.Self-inspection and quality audit -- 25.SPC, HACCp and other techniques.

This overview of quality assurance in pharmaceutical production describes the principles and practice, and discusses specific quality issues, providing a guide to both national and internatinal regulatory requirements.

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