Good Laboratory Practice for Nonclinical Studies

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

Introduction - Willie Salminen 1. Subpart A - General Provisions – Graham Bunn i) Sec. 58.1 Scope ii) Sec. 58.3 Definitions. iii) Sec. 58.10 Applicability to studies performed under grants and contracts. iv) Sec. 58.15 Inspection of a testing facility. 2. Subpart B - Organization and Personnel - Denis Roy, Bettina Donato i) Sec. 58.29 Personnel. ii) Sec. 58.31 Testing facility management. iii) Sec. 58.33 Study director iv) Sec. 58.35 Quality assurance unit. 3. Subpart C – Facilities - Willie Salminen i) Sec. 58.41 General. ii) Sec. 58.43 Animal care facilities. iii) Sec. 58.45 Animal supply facilities. iv) Sec. 58.47 Facilities for handling test and control articles. v) Sec. 58.49 Laboratory operation areas vi) Sec. 58.51 Specimen and data storage facilities 4. Subpart D – Equipment – Graham Bunn i) Sec. 58.61 Equipment design. ii) Sec. 58.63 Maintenance and calibration of equipment. 5. Subpart E - Testing Facilities Operation - Willie Salminen i) Sec. 58.81 Standard operating procedures. ii) Sec. 58.83 Reagents and solutions. iii) Sec. 58.90 Animal care. 6. Subpart F - Test and Control Articles - Denis Roy, Bettina Donato i) Sec. 58.107 Test and control article handling. ii) Sec. 58.113 Mixtures of articles with carriers. 7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study - Jeff Ambroso and Rebecca S. Bruning-Barry i) Sec. 58.120 Protocol. ii) Sec. 58.130 Conduct of a nonclinical laboratory study. 8. Subpart J - Records and Reports - Jennifer Roberts i) Sec. 58.185 Reporting of nonclinical laboratory study results. ii) Sec. 58.190 Storage and retrieval of records and data. 9. Subpart K - Disqualification of Testing Facilities - Jennifer Roberts i) Sec. 58.200 Purpose. ii) Sec. 58.202 Grounds for disqualification. iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification. iv) Sec. 58.210 Actions upon disqualification. v) Sec. 58.213 Public disclosure of information regarding disqualification. vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor. vii) Sec. 58.219 Reinstatement of a disqualified testing facility. 10. Data Integrity: Paper and Electronic 21CFR11 - Jose De La Vega

Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology and other FDA related industries in quality systems, regulatory action (FDA483, Warning Letter, Consent Decree) remediations and training. Before founding GB Consulting LLC, Graham gained extensive good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate compliance quality auditor and also in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide including Aseptic Training Programs, Batch Record Reviews, QA on the Floor and aseptic training support for 503B Compounding Centers. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and author of several book chapters and journal articles. Graham received a BSc in pharmacy from Brighton University, England, and a MSc in quality assurance and regulatory affairs from Temple University, Philadelphia and is a member of the Regulatory Affairs Professional Society (RAPS).