Header image for the post titled Guidance for Industry: The Reference Section

Anyone working in the pharmaceutical industry must have good knowledge of the relevant regulations. While attending courses and workshops is very useful in staying up to date, there is really no substitute to reading the source documents themselves. Here is my living currated “Reference Section” of regulatory documents and guidance that I keep going back to all the time. It may be useful to anyone working in clinical sample testing and/or IVD development.

GxP

  • GCP: E6(R2) Good Clinical Practice, Integrated Addendum to ICH E6(R1) Guidance for Industry. ICH, 2018 (link)
  • GCLP: Good Clinical Laboratory Practice. WHO (2009) (link)
  • GLP: 21 CFR Part 58, Good Laboratory Practice for nonclinical laboratory studies. FDA (1978) (link)
  • GLP: Principles of Good Laboratory Practice. OECD (1997) (link)
  • GMP: Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH (2000) (link)

Quality Systems

  • Q9 (R1) Guideline on Quality Risk Management. ICH (2023) (link)

Analytical/Bioanalytical Methods

  • Q14 Analytical Procedure Development. ICH (2023) (link)
    • Scope: development and maintenance of analytical procedures for evaluation of the quality of drug substances and drug products.
  • Q2(R2) Validation of Analytical Procedures. ICH (2023) (link)
    • Scope: validation of analytical procedures used for release and stability testing of commercial drug substances and products.
  • M10 Bioanalytical Method Validation and Study Sample Analysis. ICH (2022) (link)
    • Scope: validation of assays for quantification of chemical and biological drugs and their application in the analysis of study samples.
  • Bioanalytical Method Validation, Guidance for Industry. FDA (2018). (link)
    • Scope: validation of assays for human clinical pharmacology, bioavailability, or bioequivalence studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation.

Computerized Systems

  • 21 CFR Part 11, Electronic Records; Electronic Signatures - Scope and Application, Guidance for Industry. FDA (2003) (link)
  • Computerized Systems Used in Clinical Investigations, Guidance for Industry. FDA (2007) (link)
    • Supplement to 21CFR Part 11.
  • Draft, Computer Software Assurance for Production and Quality System Software FDA (2022) (link)
    • The next evolution of guidance for computerized systems in medical devices or medical device quality systems.
  • Guideline on computerised systems and electronic data in clinical trials. EMA (2023) (link)
    • Includes description of ALCOA++ principles.
  • Data Integrity and Compliance with cGMP, Draft Guidance for Industry. FDA (2016) (link)

Medical Devices

  • ISO 13485, Medical devices. ISO (2016) (paywalled link)
    • Describes Quality System requirements for medical devices
  • ISO 14971, Application of risk management to medical devices. ISO (2019) (paywalled link)
  • IVDR, Regulation on in vitro diagnostic medical devices. EU (2017) (link)
  • ISO 9001, Quality management systems. ISO (2015) (paywalled link)

Clinical Data

  • Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials. FDA (2008) (link)
  • Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues. OHRP (2010) (link)

Clinical Trials

  • Multiple Endpoints in Clinical Trials, Draft Guidance for Industry. FDA (2022). (link)