Good Clinical, Laboratory and Manufacturing Practices Techniques for the QA Professional

Spanning chemical, cosmetic and manufacturing industries.

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Podrobná bibliografie
Další autoři:	Carson, Philip, Dr. Dent, Nigel, Mr. Sweeney, Fergus, Dr.
Médium:	E-kniha
Jazyk:	angličtina
Vydáno:	Cambridge, Royal Society of Chemistry, 2007
Edice:	RSC eBook Collection 2007
ISBN:	9781847557728 : 1847557724 :
Témata:	analytická chemie Industrial applications of scientific research & technological innovation. Scientific standards. věda
On-line přístup:	Získat plný text
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Obsah:

Chapter 1: Introduction to Part 1 - GCP
Chapter 2: The Protocol, Case Report Form & Initial Documentation - Quality Assurance Involvement & Common Problems
Chapter 3: Standard Operating Procedures in the GCP Environment
Chapter 4: Preparing for Regulatory Inspections of Company Pharmacovigilance Systems & Practices in the European Union & United States
Chapter 5: Investigator, Sponsor & Contract Research Organisation Audits
Chapter 6: Data Audits
Chapter 7: Research Ethics Committees
Chapter 8: GCP/GMP Interface, Investigational Product Accountability
Chapter 9: Monitoring & Quality Control
Chapter 10: Phase I Healthy Volunteer Studies
Chapter 11: Clinical Laboratories
Chapter 12: Introduction to Part 2 - Good Laboratory Practice
Chapter 13: Quality Assurance in GLP
Chapter 14: The Master Schedule Index
Chapter 15: Study Plans & Their Audits
Chapter 16: SOPs for GLP Work
Chapter 17: Inspections - Procedural, Process & Facility
Chapter 18: Report and Data Audits
Chapter 19: Quality Assurance & Contract Research Organisations
Chapter 20: Quality Assurance & Pharmacology
Chapter 21: Application of GLP in Analytical Chemistry
Chapter 22: GLP in Drug Metabolism & Pharmacokinetics
Chapter 23: Issues of Quality in Pathology
Chapter 24: GLP in Eco-toxicology and Field Studies
Chapter 25: Animal Health
Chapter 26: Introduction to Part 3 - Good Manufacturing Practice
Chapter 27: Standard Operating Procedures (Specific to GMP)
Chapter 28: Release of Bulk & Filled Finished Product
Chapter 29: Good Manufacturing Practice for Investigational Medicinal Products
Chapter 30: Chemical Analysis
Chapter 31: GMP for Sterile Products
Chapter 32: Statistics for QA Auditors of GLP and GCP Studies
Chapter 33: The Use of Statistics in Research Quality Assurance
Chapter 34: Supplier Auditing (GMP)
Chapter 35: Centralised Supplier Audits (GLP)
Chapter 36: Document Control from Concept to Archiving