A working reference to the regulations, guidance documents, and standards behind quality systems, regulatory compliance, and validation in pharmaceutical, biotech, and medical device organizations.
This library links directly to primary sources (eCFR, FDA, the European Commission, PIC/S, ISPE, and ISO) rather than summarizing them, so you are always reading the current version. Standards from ISO, IEC, ASTM, and AAMI are typically sold through their issuing bodies; we link to the official landing page for each rather than a free mirror. We review this list periodically, but always confirm against the source for anything inspection- or submission-critical.
Whether you are building a quality system, preparing for an inspection, or validating a computerized system, these are the documents that come up most.
Current Good Manufacturing Practice for drugs. The foundation for batch records, deviations, CAPA, change control, and laboratory controls in pharmaceutical and biologic manufacturing.
View on eCFR →The Quality Management System Regulation for medical devices, effective February 2, 2026, which incorporates ISO 13485:2016 by reference. Covers design controls, CAPA, complaint handling, and supplier controls.
View on eCFR →Quality risk management and the pharmaceutical quality system. The framework regulators expect behind risk-based decisions, management review, and continual improvement.
View on ICH.org →Electronic records and electronic signatures. The baseline for audit trails, access controls, and e-signature integrity in any GxP computerized system.
View on eCFR →Final guidance (Sept. 2025; updated Feb. 2026) establishing a risk-based approach to assuring production and quality system software. Supersedes Section 6 of the 2002 General Principles of Software Validation guidance.
View on FDA.gov →Final guidance (Dec. 2018) on data integrity expectations for drug CGMP, a frequent source of Form 483 observations and warning letters.
View on FDA.gov →Regulations and guidance governing drug and biologic manufacturing, from cGMP production through controlled substances and harmonized quality standards.
General cGMP requirements applicable to drug manufacturing.
Detailed cGMP for finished pharmaceuticals, including batch production and control records.
Investigational New Drug (IND) application requirements for clinical trial shipment.
Submission and review process for New Drug Applications (NDAs).
General provisions for the manufacture and testing of biological products.
Human cells, tissues, and cellular and tissue-based products (HCT/Ps), including current good tissue practice. Relevant to cell and gene therapy.
Combination products (drug, device, and biologic), including which cGMP requirements apply to each constituent part.
Electronic records and signatures requirements applicable across all GxP computerized systems.
Standards for compounding and drug substance testing, including <795>, <797>, and <800>.
Substance-specific tests, procedures, and acceptance criteria for individual drug ingredients.
Registration requirements for manufacturers, distributors, and dispensers of controlled substances.
Labeling and packaging requirements intended to prevent misuse and diversion.
Harmonized guidance on stability testing, impurity thresholds, and risk-based quality management (Q9, Q10). A consolidated revision of the Q1 stability guidelines is in progress.
Requirements for importing pharmaceuticals and related products into the United States.
ISPE's risk-based framework for computerized system validation, updated 2022 for CSA, cloud, and agile delivery.
Final guidance on risk-based computer software assurance for production and quality system software.
EU requirements for computerised systems (Annex 11) and qualification and validation (Annex 15). A revised Annex 11 and a new Annex 22 on AI were released in draft in 2025.
Final guidance (Dec. 2018) on data integrity expectations for drug CGMP, including audit trails and access controls.
Final guidance (2003) on how FDA interprets and enforces Part 11. Still the reference auditors cite for audit trails, validation, and record retention.
Good practices for data management and integrity in GMP/GDP environments (2021), used by inspectorates worldwide.
UK guidance (2018) on data integrity principles, governance, and culture across GxP activities.
Final guidance (2011) establishing the three-stage lifecycle approach: process design, process qualification, and continued process verification.
Regulations and standards governing device quality systems, design controls, and electrical, software, and sterilization safety, including the QMSR, effective February 2, 2026.
Quality Management System Regulation, effective Feb. 2, 2026, incorporating ISO 13485:2016 by reference.
Medical Device Reporting obligations for device-related adverse events and malfunctions.
Reporting requirements for device corrections and field removals.
European Union Medical Device Regulation governing CE marking, clinical evaluation, and post-market surveillance.
European Union regulation for in vitro diagnostic medical devices.
Risk-based software assurance guidance for production and quality management system software.
Cybersecurity expectations for device design and premarket submissions, revised February 2026 to align with the QMSR.
Medical Device Single Audit Program: one QMS audit accepted by regulators in the U.S., Canada, Brazil, Japan, and Australia.
Quality management system requirements for medical devices, now incorporated into 21 CFR Part 820.
Application of risk management to medical devices throughout the product lifecycle.
Good clinical practice for the design and conduct of clinical investigations of medical devices.
Principles for the biological evaluation of medical devices within a risk management process.
Symbols for use in device labeling, packaging, and accompanying information.
General requirements for basic safety and essential performance of medical electrical equipment.
Software life cycle requirements for medical device software (2006, amended 2015), closely related to validation lifecycle practice. A second edition is in development.
Application of usability engineering to medical devices.
Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
Human factors engineering principles for medical device design and usability.
Radiation sterilization requirements for healthcare products.
Accelerated aging methods for sterile barrier packaging systems.
Cybersecurity series for network-connectable products, including connected medical devices.
How FDA plans and conducts inspections, and where its findings are published. Useful for inspection readiness, mock audits, and benchmarking your risk against recent enforcement.
The primary operational reference for FDA investigators, updated annually. Shows how inspections are conducted, documented, and closed out.
The programs investigators follow for drug, biologic, and device inspections, including what gets covered and how findings are classified.
Annual spreadsheets summarizing the regulations most often cited on Form 483s, by product area, going back to 2006.
Searchable database of warning letters by company, date, and subject.
Inspection outcomes and classifications for domestic and foreign sites, by fiscal year and product type.
If a regulatory transition or a system validation effort means you need experienced hands now, we can help you find them.