GMP, GCP and GLP Bundle

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).

• 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. 2 An overview of Good Clinical Practices. 3 Quality by Design, Critical to Quality Factors - ICH E8 (R1). 4 Good Clinical Practice ICH E6 (R2 and R3). 5 Clinical Safety Data Management ICH E2A. 6 21 CFR 50 – Informed Consent. 7 21 CFR 54 – Financial Disclosure. 8 21 CFR 56 – Institutional Review Boards. 9 Protected Health Information and Privacy in Clinical Trials (HIPAA). 10 Good Pharmacovigilance Practices (GVP). 11 Data Integrity and 21CFR11 for GCPs. 12 Preparing for FDA inspections at sponsor/investigator sites. 13 Regulations relating to the Placebo response in Clinical research.Good Manufacturing Practices for Pharmaceuticals, Eighth Edition. Preface. Contributors. About The Editor. Chapter 1: Status and Applicability of U.S. Regulations: CGMP. Chapter 2: Quality Management Systems and Risk Management. Chapter 3: Management Responsibility and Control. Chapter 4: Organization and Personnel. Chapter 5: Finished Pharmaceuticals: General Provisions. Chapter 6: Production and Process Controls. Chapter 7: Records and Reports. Chapter 8: Clinical Trial Supplies. Chapter 9: Contracting and Outsourcing. Chapter 10: Buildings and Facilities. Chapter 11: Equipment. Chapter 12: Control of Components and Drug Product Containers and Closures. Chapter 13: Holding and Distribution. Chapter 14: Returned and Salvaged Drug Products. Chapter 15: Active Pharmaceutical Ingredients. Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices. Chapter 17: Packaging and Labeling Control. Chapter 18: Laboratory Controls. Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities. Chapter 20: CGMP Enforcement Alternatives in the United States. Chapter 21: FDA Inspection Process. Chapter 22: FDA Pre-approval Inspections. Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection. Chapter 24: The Qualified Person in the Pharmaceutical Industry. Chapter 25: Data Integrity and Fundamental Responsibilities. Index