000 01825nam a2200193Ia 4500
008 140223b2007 xxu||||| |||| 00| 0 eng d
020 _a9780854048342
_c0.00
082 _a615.4
_bGOO
245 _aGood Clinical, Laboratory and Manufacturing Practices
260 _aCambridge
_bThe Royal Society of Chemistry
_c2007
300 _a622p
500 _aWritten by a team of world experts the book provides practical and detailed advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of pre-clinical safety studies, clinical trials and manufacture of drugs. It provides a framework for integrating these standards with other quality management systems. Detailed examples are provided to illustrate application of the principles.The book is targeted primarily at all those subjected to internal and external inspection and audit for compliance with the requirements of good clinical, good laboratory, and good manufacturing practices. It will be of value to chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians, and toxicologists. The section on harmonisation of quality systems is also of value to safety, health, and environment advisors.It is a source of authoritative reference and training material on research and manufacturing quality for the chemical, cosmetic, and pharmaceutical industries, and in contract research organisations, universities and government establishments.
600 _aClinical Pharmacy
_98371
600 _aClinical Practice
_917053
700 _aCarson, P. A.
_eEditor
_917054
700 _aDent, N.
_eEditor
_917055
942 _2ddc
_cLB
_k615.4
_mGOO
995 _aPharmacy Reference
_eP0005146
_j615.4
_yP0005146
999 _c15556
_d15556