An Overview of GLP Archive Regulations and the

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 Representing Society of Quality Assurance (SQA)

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

U. S. Regulatory Environment Food 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)

U. S. Regulatory Environmental 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/pesticideregistration/about-pesticide-registration

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

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

Quality Assurance Professional Balancing business, regulatory and product quality and safety needs

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.

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

35 th 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!

Upcoming Training – Quality College 19 courses 28 -29 April 2019; 2 -3 May 2019 In conjunction with the 35 th SQA Annual Meeting in Atlanta, Georgia.

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

SQA Online Learning View th module e first of and GL the GCP P cours es for FRE E! 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 Visit www. sqa. org/learn for details! RQAP re-registration units are available for individual courses Basic Training: GLP GCP: Understanding the Basics Writing Effective Compliant GLP SOPs

SQA Online Learning continued Two 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!

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

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

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 GMP Beyond Compliance Medical Device Bioanalytical Pharmacovigilance Clinical QA Consulting Support Computer Validation Scientific Archiving GLP (with EPA subcommittee) University

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