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

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


  • 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)