References and Regulatory Information

Regulatory Databases:

FDA Compliance Program Guidance Manual Database
http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm

FDA Guidance Document Database
http://www.fda.gov/regulatoryinformation/guidances/

FDA Warning Letter Database
http://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm

Regulations and Principles:

FDA Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR Part 58 https://www.ecfr.gov/cgi-bin/text-idx?SID=70382a00fb2f070face55cd808cbd3e3&mc=true&tpl=/ecfrbrowse/Title21/21cfr58_main_02.tpl

FDA New Drug and Biological Drug Products; Evidence needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible, 21 CFR Parts 314 and 601

FDA Electronic Records; Electronic Signatures, 21 CFR Part 11 https://www.ecfr.gov/cgi-bin/text-idx?SID=70382a00fb2f070face55cd808cbd3e3&mc=true&tpl=/ecfrbrowse/Title21/21cfr11_main_02.tpl

FDA Quality System Regulations, 21 CFR Part 820 https://www.ecfr.gov/cgi-bin/text-idx?SID=70382a00fb2f070face55cd808cbd3e3&mc=true&tpl=/ecfrbrowse/Title21/21cfr11_main_02.tpl

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring (Consensus Documents)
http://www.oecd-ilibrary.org/environment/oecd-series-on-principles-of-good-laboratory-practice-and-compliance-monitoring_2077785x

Selected Guidelines and Guidance Documents:

Animal Models—Essential Elements to Address Efficacy Under the Animal Rule
FDA Guidance for Industry. 2009
PDF document

Bioanalytical Method Validation
FDA Draft Guidance for Industry. Sept. 2013
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf

Bioanalytical Method Validation
FDA Guidance for Industry. May, 2018.
http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf

Good Laboratory Practices Questions and Answers
FDA Guidance for Industry. July, 2007. http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133748.pdf
See also: http://www.fda.gov/ICECI/Inspections/NonclinicalLaboratoriesInspectedunderGoodLaboratoryPractices/ucm072738.htm

Process for Drug Development Tools
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-process-drug-development-tools-guidance-industry-and-fda-staff

Product Development Under the Animal Rule
FDA Guidance for Industry. October 2015 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-development-under-animal-rule

Q2B Validation of Analytical Procedures: Methodology
FDA Guidance for Industry. May 1997 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2b-validation-analytical-procedures-methodology

Text on Validation of Analytical Procedures ICH Q2A
FDA Guidance for Industry, March 1995 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2a-text-validation-analytical-procedures

Other Helpful Documents and Websites:

Advancing Regulatory Science (includes FDA Strategic Plan for Regulatory Science)
FDA Science and Research Special Topic https://www.fda.gov/science-research/science-and-research-special-topics/advancing-regulatory-science?utm_campaign=Goo

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and OECD Principles of GLP
http://www.fda.gov/iceci/enforcementactions/bioresearchmonitoring/ucm135197.htm

Guidance for Preparing Standard Operating Procedures
EPA QA/G-6, April, 2007 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/comparison-chart-fda-and-epa-good-laboratory-practice-glp-regulations-and-oecd-principles-glp

How to Start—and Keep—a Laboratory Notebook: Policy and Practical Guidelines
Jennifer A. Thomson, University of Cape Town, South Africa
http://www.iphandbook.org/handbook/ch08/p02/

Quality System Workbook
Research Quality Association (free download) https://www.therqa.com/resources/publications/booklets/Quality_Systems_Guide/

World Health Organization Good Laboratory Practice Manuals
https://www.who.int/tdr/publications/laboratory_practice/en/

Animal Rule Information
https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-information

FDA Bioresearch Monitoring Information Page
http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/default.htm

Handbook: Quality practices in basic biomedical research
https://www.who.int/tdr/publications/training-guideline-publications/handbook-quality-practices-biomedical-research/en/

Inspection of Nonclinical Laboratories Conducting Animal Rule Specific Studies (FDA Compliance Manual)
https://www.fda.gov/media/124862/download

Making the Right Moves: A Practical Guide to Scientific Management for Postdocs and new Faculty, Second Edition
https://www.hhmi.org/science-education/programs/making-right-moves

Society of Quality Assurance
www.sqa.org

Quality Systems for Research Laboratories
https://www.therqa.com/learning/events/course/quality-systems-for-research-laboratories/