Good Laboratory Practice for Nonclinical Studies
Introduction
1. Subpart A - General Provisions
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
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
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
i) Sec. 58.61 Equipment design.
ii) Sec. 58.63 Maintenance and calibration of equipment.
5. Subpart E - Testing Facilities Operation
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
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
i) Sec. 58.120 Protocol.
ii) Sec. 58.130 Conduct of a nonclinical laboratory study.
8. Subpart J - Records and Reports
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 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
Good Clinical Practices in Pharmaceuticals
Preface
About the Editor
List of Contributors
Introduction
1 Regulatory Application Requirements
Shanthi Ganeshan and Connie Freund
2 An overview of Good Clinical Practices
John Klein and Sonya Edgerton
3 Quality by Design, Critical to Quality Factors - ICH E8 (R1)
Sam Sather and Jennifer Lawyer
4 Good Clinical Practice ICH E6 (R2 and R3)
John Klein and Sonya Edgerton
5 Clinical Safety Data Management ICH E2A
Karen Truhe
6 21 CFR 50 – Informed Consent
Joe Near
7 21 CFR 54 – Financial Disclosure
Glenda Guest
8 21 CFR 56 – Institutional Review Boards
Aurea Flores
9 Protected Health Information and Privacy in Clinical Trials (HIPAA)
Sam Sather
10 Good Pharmacovigilance Practices (GVP)
Jessica Chu
11 Data Integrity and 21CFR11 for GCPs
Randall Basinger
12 Preparing for FDA inspections at sponsor/investigator sites
Tommy Lee and Sam Sather
13 Regulations relating to the Placebo response in Clinical research
Graham Bunn and Arthur Ooghe
Good Manufacturing Practices Pharmaceuticals, Eighth Edition
Preface
Contributors
About The Editor
Chapter 1: Status and Applicability of U.S. Regulations: CGMP
Graham P. Bunn
Chapter 2: Quality Management Systems and Risk Management
Joseph C. Near
Chapter 3: Management Responsibility and Control
John E. Snyder
Chapter 4: Organization and Personnel
Graham P. Bunn, Joanna B. Gallant
Chapter 5: Finished Pharmaceuticals: General Provisions
Graham P. Bunn
Chapter 6: Production and Process Controls
Jocelyn A. Zephrani
Chapter 7: Records and Reports
Graham P. Bunn
Chapter 8: Clinical Trial Supplies
David Stephon
Chapter 9: Contracting and Outsourcing
Joseph C. Near
Chapter 10: Buildings and Facilities
Robert Del Ciello
Chapter 11: Equipment
Robert Del Ciello, Joseph T. Busfield
Chapter 12: Control of Components and Drug Product Containers and Closures
Graham P. Bunn
Chapter 13: Holding and Distribution
Andrew Acker
Chapter 14: Returned and Salvaged Drug Products
Graham P. Bunn
Chapter 15: Active Pharmaceutical Ingredients
Joseph C. Near
Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices
Irwin Silverstein
Chapter 17: Packaging and Labeling Control
Graham P. Bunn
Chapter 18: Laboratory Controls
Alex M. Hoinowski
Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities
Stephanie A. Slater and Daniel J. Roberts
Chapter 20: CGMP Enforcement Alternatives in the United States
Daniel G. Jarcho, Cathy L. Burgess
Chapter 21: FDA Inspection Process
Cathy L. Burgess, Daniel G. Jarcho
Chapter 22: FDA Pre-approval Inspections
Cathy L. Burgess, Justin Mann, Seth Olson
Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection
Daniel J. Roberts and Stephanie A. Slater
Chapter 24: The Qualified Person in the Pharmaceutical Industry
Adrian Chowdhary
Chapter 25: Data Integrity and Fundamental Responsibilities
Randy Hightower, Michele Pruett
Index
Biography
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).
