An Overview of GLP Archive Regulations and the Society of Quality Assurance

1. An Overview of GLP Archive Regulations and the Society of Quality Assurance Association of Records and Management Administration (ARMA) Presented by Tanja Vaneman, RQAP-GLP RepresentingSociety of Quality Assurance (SQA)

2. Presentation Overview • GLP Regulations, Record Archival • The Quality Assurance Professional • Professional Support through the Society of Quality Assurance

3. U.S. Regulatory EnvironmentFood and Drug Administration (FDA) • Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) • Multiple regulations and guidance documents for industry • Excellent online resources at https://www.fda.gov/ • Acceptance of harmonized standards in • GLP: Organization for Economic Cooperation and Development (OECD) • GCP and GMP: International Conference on Harmonization (ICH)

4. U.S. Regulatory EnvironmentEnvironmental Protection Agency (EPA) • EPA is responsible for environmental and human effects of pesticides and chemical/toxic substances • GLP-based with allowances for human subject research on pesticide exposure • Excellent online resources at https://www.epa.gov/pesticide-registration/about-pesticide-registration

5. GLP Regulations Relevant for Archives • Congress mandated medicines should be safe and effective • Law govern nonclinical safety study data quality and integrity, to support applications for research or marketing permits for products regulated by the FDA/EPA • Record retention is required for study reconstruction, minimum length of retention is determined by either application submittal or application approval date • Defines Quality Assurance Unit, separate and independent auditors • Defines GLP Archivist, one individual responsible for the GLP Archives

6. Archival of GLP Records • Archived during or at the close of the study • Orderly storage and expedient retrieval • Types: • Raw data • Protocol, Report • Specimens (preserved tissues, paraffin blocks, glass slides) • Reserve Test Article

7. Quality Assurance ProfessionalBalancing business, regulatory and product quality and safety needs

8. Mission Statement:Promote and advance the principles and knowledge of quality assurance essential to human, animal and environmental health. Vision Statement:A world with safe and effective biologics, chemicals, drugs and medical devices for humans, animals and the environment. 

9. WWW.SQA.ORG • Members-only access to • Regulatory Resources • Specialty Section Networking and Discussion • Career and Mentoring Opportunities • Quality Matters e-newsletter, and more!

10. 35th SQA Annual Meeting & Quality College 8-13 April 2018 Anaheim Marriott, Anaheim, California, USA The Wonderful World of Quality Beautiful Orange County is home to world-famous theme parks, distinguished shopping districts, championship golf courses, professional sports teams and trendy beach towns. It’s the perfect destination for a working vacation!

11. Upcoming Training – Quality College19 courses 28-29 April 2019; 2-3 May 2019 In conjunction with the 35th SQA Annual Meeting in Atlanta, Georgia.

12. Upcoming Training – Quality College in Atlanta 1-GLP 101: Basic Training, 2 DAYS 2-GCP 101: Understanding the Basics, 2 DAYS 3-CAPA 101: Problem Definition – Beyond Human Error 4-CSV 101: Basic Concepts in Computer Validation, 2 DAYS 5-Vet 101: Veterinary GCP Basics 6-PV 201: Intermediate Pharmacovigilance Auditing, 2 DAYS 7-CAPA 201: CAPA Creation and Effectiveness - Across GxPs 8-Vet 201: Veterinary GCP Intermediate Topics 9-GCP 202: Hot Topics & Industry Trends 10-GMP 101: Basic Training: History and Introduction of the US FDA GMPs 11-GLP 103: Basic GLP Archiving 12-General 102: SQA Leadership Development 13-GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today 14-GLP 203: Intermediate GLP Archiving 15-GLP 104: Auditing Techniques 16-General 106: Auditor's Primer: Chromatography & Mass Spectrometry 17-GCP 201: Advanced Training 18-General 201: Systems Thinking in Quality Management 19-General 104: Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting

13. SQA Online Learning View the first module of the GCP and GLP courses for FREE! • On-demand — Access any time, anywhere you have an internet connection • Self-paced — Work through the modules at your own pace • Interactive — Course includes interspersed review questions, and a quiz at the end of each module • Printable certificates of completion are available • RQAP re-registration units are available for individual courses Visit www.sqa.org/learn for details! Basic Training: GLP GCP: Understanding the Basics Writing Effective Compliant GLP SOPs

14. SQA Online Learning continuedTwo courses launched in 2018 GLP Study Director and Principal Investigator Training Introduction to 21 CFR Part 11: Electronic Records; Electronic Signatures Visit www.sqa.org/learn for details!

15. Global QA Conference • 2020 – Sendai, Japan – hosted by the Japan Society of Quality Assurance • 2023 – Gaylord National; National Harbor, Maryland, USA – hosted by SQA

16. RQAP Program • Registered Quality Assurance Professional (RQAP) • Laboratory and Field • RQAP-GLP • Clinical • RQAP-GCP

17. Specialty Sections The Specialty Sections provide members with a forum for discussion and information sharing in their specific areas of the research Quality Assurance field and also contribute to Society education and publications in their specialty areas. Animal Health Beyond Compliance Bioanalytical Clinical Computer Validation GLP (with EPA subcommittee) GMP Medical Device Pharmacovigilance QA Consulting Support Scientific Archiving University

18. Regional Chapters North Carolina Regional Chapter Mid-West Regional Chapter New England Regional Chapter Southern Regional Chapter International Chapters Nigerian Chapter Indian Chapter Canadian Chapter