Good Clinical, Laboratory and Manufacturing

Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Introduction : good clinical practice	p. 3
The protocol, case report from and initial documention : quality assurance involvement and common problems	p. 13
Standard operating procedures in the good clinical practice environment	p. 39
Preparing for regulatory inspection of company pharmacovigilance systems and practices in the European Union and United States	p. 57
Investigator, sponser and contract research organisation audits	p. 73
Data audits	p. 89
Research ethics committees	p. 99
Good clinical practice/good manufacturing practice (GCP/GMP) interface, investigational product accountability	p. 109
Monitoring and quality control	p. 121
Phase I healthy volunteers studies	p. 137
Clinical laboratories	p. 147
Introduction : good laboratory practice	p. 171
Quality assurance in GLP	p. 183
The master schedule index	p. 199
Study plans and their audits	p. 209
Standard operating procedures for good laboratory practice work	p. 223
Inspections : procedural, process and facility	p. 235
Report and data audits	p. 249
Quality assurance and contract research organisation : GLP studies	p. 263
Good laboratory practice and pharmacology	p. 271
Application of GLP in analytical chemistry with cross reference to GMP and GCP	p. 279
GLP in drug metabolism and pharmacokinetics	p. 305
Issues of quality in pathology	p. 317
Good laboratory practices in ecotoxicology and field studies	p. 335
Animal health	p. 353
Introduction : good manufacturing practice	p. 371
Standard operating procedures	p. 387
Release of bulk and filled finished product	p. 399
Good manufacturing practice for investigational medicinal products	p. 407
Chemical analysis	p. 419
Good manufacturing practice for sterile products	p. 435
Statistics for QA auditors of GLP and GCP studies	p. 463
Metrics and trend analysis	p. 473
Supplier auditing	p. 479
Centralised supplier audits for animal studies	p. 489
Document control : from concept to archiving	p. 497
Computing and GXPs	p. 511
QA developing a regulatory compliance training strategy : an opportunity for QA to improve quality and provide greater value to the business	p. 529
Training and staff records for GXP	p. 541
Integrating quality systems	p. 551
Table of Contents provided by Blackwell. All Rights Reserved.

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Good Clinical, Laboratory and Manufacturing Practices

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