TY  - BOOK
AU  - Sharp,J.R.
TI  - Quality in the manufacture of medicines and other healthcare products
SN  - 9780853694311 (hbk.) :
AV  - RS403 
U1  - 615.19 SHA 
PY  - 2000///
CY  - London
PB  - Pharmaceutical Press
KW  - Pharmaceutical industry
KW  - Quality control
KW  - Industrial quality control
KW  - thema
KW  - Pharmaceutical chemistry & technology
KW  - Manufacturing industries
KW  - Health and Wellbeing
KW  - ukslc
KW  - Drug industry
KW  - Standards
KW  - Technology, Pharmaceutical
N1  - 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
N2  - 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
ER  -