Regulations Archive - StabilityHub

Stability Regulations

This segment is a growing collection of laws, guidances and requirements pertaining to the stability function from various nations and recognized global and regional organizations. While some are legal requirements, others are guidances that can be fulfilled with justified alternative measures, but all are expectations of duly authorized regulatory bodies.

Not sure what you’re looking for? Browse the Hubrary Classification System across all of StabilityHub’s data!

Regulations by Regulatory Body

…or use the search to discover other stability regulations!

China (NMPA) Stability Studies of Pharmaceutical Packaging Materials in China
CHPA Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an NDA/ANDA
Development of the Chinese Pharmacopoeia 2020 Edition General Chapters: A Review
EMA Guideline: Stability Testing of Existing Active Substances and Related Finished Products 2007
FDA Guidance CMC Changes to an Approved Application: Certain Biological Products
FDA Guidance for CMC Information for Human Gene Therapy INDs
Health Canada Guidance Document: Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDAs) 2017
Health Canada Guidelines for environmental control of drugs during storage and transportation (GUI-0069)
ICH Q10 - Pharmaceutical Quality System - Briefing Presentation
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotech/Biological Entities
ICH Q3D Final Concept Paper Q3D: Elemental Impurities IWG
ICH Q6B Specifications: Test Procedures and Application Criteria for Biotechnical/Biological Products
ICH Q9 R1 Quality Risk Management
IPEC Safety Guide for Pharmaceutical Excipients (2021)
Questions and Answers for Q11 Development and Manufacture of Drug Substances
ANVISA

ANVISA RDC N° 318/2019 Criteria for conducting Stability Studies for APIs and Drug Products
Guidances • Regulatory
ASEAN

ANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF-LIFE OF TRADITIONAL MEDICINES
Guidances • Regulatory
ASTM

ASTM D-4332-14 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
Guidances • Regulatory
ASTM

ASTM F-1980-16 Std Guide Accelerated Aging of Sterile Barrier Systems for Med Devices
Guidances • Regulatory
ASTM

ASTM-F-2097-16 Guide for Design and Evaluation of Primary Packaging for Medical Products
Guidances • Regulatory
CFR 211

US Regulation 21 CFR 211.166 Stability testing
Regulations • Regulatory
CFR 820

US Regulation 21 CFR 820 Medical Devices
Regulations • Regulatory
Clinical and Laboratory Standards Institute

EP 25A Evaluation of Stability of In-Vitro Diagnostic Reagents; Approved Guideline
Guidances • Regulatory
EMA

EMA ‘Guideline on declaration of storage conditions: A: in the product information of medicinal products B: for active substances CPMP/QWP/609/96/Rev 2 (2007):
Guidances • Regulatory
EMA

EMA ‘Quality of medicines questions and answers: Part 1’
Guidances • Regulatory
EMA

EMA ‘Quality of medicines questions and answers: Part 2’
Guidances • Regulatory
EMA

EMA Guideline on stability testing for applications for variations to a marketing authorisation
Guidances • Regulatory
EMA

EMA Guideline on the requirements for the chemical & pharmaceutical quality documentation concerning investigational medical products in clinical trials
Guidances • Regulatory
EMA

EMA Note for Guidance on In-Use Stability Testing of Human Medicinal Products March 1 2001
Guidances • Regulatory
EMA

EMA Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)
Guidances • Regulatory
EU Regulations

EU Regulation Annex 1 2020 Rev 2 for comment Manufacture of Sterile Products
Regulations • Regulatory
EU Regulations

EU Regulation Annex 19 Reference and Retention Samples 2005
Regulations • Regulatory
EU Regulations

EU Regulation Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 6: Quality Control Sections 6.26-6.36
Regulations • Regulatory
FDA

FDA (QSIT) Quality Systems Inspection Technique process
Guidances • Regulatory
FDA

FDA 1998 Withdrawn Guidance for Industry Stability Testing of Drug Substances and Drug Products
Guidances • Regulatory
FDA

FDA Draft Guidance Quality Considerations for Continuous Manufacturing Products
Guidances • Regulatory
FDA

FDA Drug Compliance Program Manual
Guidances • Regulatory
FDA

FDA Expiration Dating and Stability Testing for Human Drug Products (1985/2014)
Guidances • Regulatory
FDA

FDA Guidance Effects of COVID-19 on Meetings and User Fees Q&As
Guidances • Regulatory
FDA

FDA Guidance Expiration Dating and Stability Testing for Human Drug Products
Guidances • Regulatory
FDA

FDA Guidance for Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
Guidances • Regulatory
FDA

FDA Guidance for Industry and FDA Staff CGMP Requirements for Combination Products
Guidances • Regulatory
FDA

FDA Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
Guidances • Regulatory
FDA

FDA Guidance for Industry Drug Products, including biological products, that contain nanomaterials April 2022
Guidances • Regulatory
FDA

FDA Guidance for Industry Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
Guidances • Regulatory
FDA

FDA Guidance for Pharmaceutical Quality Control Labs (July 1993)
Guidances • Regulatory
FDA

FDA Guidance Immediate Release Solid Oral Scale-Up & Postapproval Changes CMC In-VitroDissolution & In-Vivo Bioequivalence Documentation
Guidances • Regulatory
FDA

FDA Guidance In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
Guidances • Regulatory
FDA

FDA Guidance M10 BioAnalytical Method Validation and Study Sample Analysis
Guidances • Regulatory
FDA

FDA Guidance Methods, Method Verification and Validation
Guidances • Regulatory

12 3 Next

Not sure what you’re looking for? Browse the Hubrary Classification System across all of StabilityHub’s data!

Advance Stability Knowledge

Would you like to see a particular publication, guidance, organization, supplier, event, or career opportunity on StabilityHub? Contact us with your suggestion!

Find Resources

Get Involved

the Situation Room

Regulations

Stability Regulations

Regulations by Regulatory Body

…or use the search to discover other stability regulations!

Advance Stability Knowledge

Navigate

Upcoming Events

Navigate

Sign Up for Stability News