Access essential regulations, quality standards, and international guidances for GMP, quality systems, validation, data integrity, and more—sourced directly from FDA, EMA, ICH, WHO, and PIC/S.
Explore our curated collection of guidance documents, regulatory links, training tools, and compliance resources to support your pharmaceutical, biotech, and advanced therapy quality initiatives.
21 CFR Part 210 – CGMP for Drugs (FDA)
Defines manufacturing practices for drug products.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
21 CFR Part 211 – CGMP for Finished Pharmaceuticals (FDA)
Outlines cGMP requirements for finished drug products.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
EU GMP Guidelines – EudraLex Volume 4 (EMA)
European GMP guide for pharmaceuticals and ATMPs.
🔗 https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
WHO GMP Guidelines
International GMP standards for pharmaceutical quality.
🔗 https://www.who.int/publications/i/item/WHO-TRS-1025-annex-2
PIC/S GMP Guide
Harmonized GMP guidance from the Pharmaceutical Inspection Co-operation Scheme.
🔗 https://picscheme.org/en/publications
Explore our curated collection of guidance documents, regulatory links, training tools, and compliance resources to support your pharmaceutical, biotech, and advanced therapy quality initiatives.
21 CFR Part 210 – CGMP for Drugs (FDA)
Defines manufacturing practices for drug products.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
21 CFR Part 211 – CGMP for Finished Pharmaceuticals (FDA)
Outlines cGMP requirements for finished drug products.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
EU GMP Guidelines – EudraLex Volume 4 (EMA)
European GMP guide for pharmaceuticals and ATMPs.
🔗 https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
WHO GMP Guidelines
International GMP standards for pharmaceutical quality.
🔗 https://www.who.int/publications/i/item/WHO-TRS-1025-annex-2
PIC/S GMP Guide
Harmonized GMP guidance from the Pharmaceutical Inspection Co-operation Scheme.
🔗 https://picscheme.org/en/publications
Explore our curated collection of guidance documents, regulatory links, training tools, and compliance resources to support your pharmaceutical, biotech, and advanced therapy quality initiatives.
ICH Q10 – Pharmaceutical Quality System
Global model for an integrated pharmaceutical QMS.
🔗 https://database.ich.org/sites/default/files/Q10_Guideline.pdf
ISO 13485:2016 – Medical Devices QMS
International standard for device QMS. (Purchase required)
🔗 https://www.iso.org/standard/59752.html
21 CFR Part 820 – Quality System Regulation (FDA)
Regulatory requirements for medical device QMS.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
Explore our curated collection of guidance documents, regulatory links, training tools, and compliance resources to support your pharmaceutical, biotech, and advanced therapy quality initiatives.
21 CFR Part 11 – Electronic Records
Governs use of electronic systems in regulated environments.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
GAMP 5 Guide – ISPE (Summary)
Best practices for computer systems validation. (Purchase full guide)
🔗 https://ispe.org/publications/guidance-documents/gamp-5
WHO Data Integrity Guidance
Global framework for managing data in GxP environments.
🔗 https://www.who.int/publications/i/item/9789241550141
21 CFR Part 210 – CGMP for Drugs (FDA)
Defines manufacturing practices for drug products.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
21 CFR Part 211 – CGMP for Finished Pharmaceuticals (FDA)
Outlines cGMP requirements for finished drug products.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
EU GMP Guidelines – EudraLex Volume 4 (EMA)
European GMP guide for pharmaceuticals and ATMPs.
🔗 https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
WHO GMP Guidelines
International GMP standards for pharmaceutical quality.
🔗 https://www.who.int/publications/i/item/WHO-TRS-1025-annex-2
PIC/S GMP Guide
Harmonized GMP guidance from the Pharmaceutical Inspection Co-operation Scheme.
🔗 https://picscheme.org/en/publications
21 CFR Part 11 – Electronic Records & Signatures (FDA)
Regulates electronic systems for records and signatures.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
MHRA GxP Data Integrity Guidance
UK regulatory expectations for data integrity.
🔗 https://www.gov.uk/government/publications/gxp-data-integrity-guidance-and-definitions
WHO Guidance on Good Data and Record Management
Covers documentation and data governance in GMP.
🔗 https://www.who.int/publications/i/item/9789241550141
PIC/S PI 041 – Data Integrity Guidance
Comprehensive guidance on managing data integrity.
🔗 https://picscheme.org/en/publications
ICH Q10 – Pharmaceutical Quality System
Global model for an integrated pharmaceutical QMS.
🔗 https://database.ich.org/sites/default/files/Q10_Guideline.pdf
ISO 13485:2016 – Medical Devices QMS
International standard for device QMS. (Purchase required)
🔗 https://www.iso.org/standard/59752.html
21 CFR Part 820 – Quality System Regulation (FDA)
Regulatory requirements for medical device QMS.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
21 CFR Part 11 – Electronic Records
Governs use of electronic systems in regulated environments.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
GAMP 5 Guide – ISPE (Summary)
Best practices for computer systems validation. (Purchase full guide)
🔗 https://ispe.org/publications/guidance-documents/gamp-5
WHO Data Integrity Guidance
Global framework for managing data in GxP environments.
🔗 https://www.who.int/publications/i/item/9789241550141
ICH Q2(R2) – Analytical Method Validation
Standards for method validation in quality control.
🔗 https://www.ich.org/page/quality-guidelines
USP <1225> – Validation of Compendial Procedures
Provides procedures for validating analytical methods. (Subscription required)
🔗 https://www.usp.org/resources/compendial-tools
USP <1058> – Analytical Instrument Qualification
Guidelines for qualifying lab instruments.
🔗 https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc1058_rb_notice_2021-02-26.pdf
FDA Guidance – Investigating OOS Results
Guides OOS investigations in lab environments.
🔗 https://www.fda.gov/media/71001/download
ICH Q1A(R2) – Stability Testing
Stability testing for new drug substances and products.
🔗 https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf
21 CFR 211.192 – Production Record Review
Requires thorough review of batch records and deviations.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/section-211.192
21 CFR 211.198 – Complaint Files
Mandates investigation of product quality complaints.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/section-211.198
ICH Q9 – Quality Risk Management
Framework for integrating risk management into quality.
🔗 https://database.ich.org/sites/default/files/Q9_Guideline.pdf
ICH Q10 – CAPA Integration
Links CAPA, QMS, and risk management.
🔗 https://database.ich.org/sites/default/files/Q10_Guideline.pdf
PIC/S PI 010-4 – CAPA Investigation Guidance
Comprehensive guide for deviation and CAPA handling.
🔗 https://picscheme.org/en/publications
ICH Q8(R2) – Pharmaceutical Development
Applies QbD to pharmaceutical product development.
🔗 https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
ICH Q9 – Risk Management
Risk-based decision making throughout the product lifecycle.
🔗 https://database.ich.org/sites/default/files/Q9_Guideline.pdf
ICH Q10 – Lifecycle Quality System
Describes how quality systems support lifecycle management.
🔗 https://database.ich.org/sites/default/files/Q10_Guideline.pdf
EU GMP Annex 15 – Qualification & Validation
Validation expectations for facilities, systems, and processes.
🔗 https://health.ec.europa.eu/system/files/2016-11/annex15_0.pdf
21 CFR 211.100 – Written Procedures
Requires written procedures for production and process control.
🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/section-211.100
FDA Process Validation Guidance (2011)
Three-stage approach to process validation.
🔗 https://www.fda.gov/media/71021/download
ICH Q2(R2) – Analytical Validation
Global validation standard for analytical procedures.
🔗 https://www.ich.org/page/quality-guidelines
FDA Cleaning Validation Guidance (1993)
Outlines expectations for cleaning process validation.
🔗 https://www.fda.gov/media/71021/download#page=45
GAMP 5 Guide Summary (ISPE)
Industry-standard for computer system validation. (Purchase required)
🔗 https://ispe.org/publications/guidance-documents/gamp-5
FDA Guidance for Industry – Search Tool
Search all current and archived FDA guidance documents.
🔗 https://www.fda.gov/regulatory-information/search-fda-guidance-documents
FDA Field Management Directives (FMDs)
Internal FDA procedures for field staff and inspectors.
🔗 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/field-management-directives-fmds
Compliance Program Guidance Manuals (CPGMs)
FDA manuals used for inspections and compliance reviews.
🔗 https://www.fda.gov/media/75963/download
ORA Investigations Operations Manual (IOM)
FDA’s inspection procedures manual.
🔗 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual
FDA Draft Guidances
Track draft guidances open for public comment.
🔗 https://www.fda.gov/regulatory-information/search-fda-guidance-documents
FDA Data Dashboard
Interactive data on inspections, recalls, and drug shortages.
🔗 https://datadashboard.fda.gov/
FDA 483 Inspection Observations
Year-by-year data on FDA Form 483 citations.
🔗 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-observations
FDA Warning Letter Database
Searchable archive of warning letters issued by FDA.
🔗 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
