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!

Brazil (ANVISA) Quality

Brazil, ANVISA, Article-General Provisions for Stability Studies of Active Pharmaceuticals and Medicines
Vistaar Blog regarding ANVISA Resolution RDC 318/2019 (Also linked in Publications)

Guidances • Regulatory
Canada (HC) GMP

Canada, HC, Guidance-Guidelines for environmental control of drugs during storage and transportation (GUI-0069)
Issued August 2020
Canada (HC) Quality

Canada, HC, Guidance-Stability Testing of Existing Drug Substances and Products
Superceded by 2017 Quality CMC

Guidances • Regulatory
Canada (HC) Submissions

Canada, HC, Guidance-Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Effective 30 January 2018

Guidances • Regulatory
China - NMPA

China (NMPA) Stability Studies of Pharmaceutical Packaging Materials in China
China (NMPA)

Development of the Chinese Pharmacopoeia 2020 Edition General Chapters: A Review - Article from Science Direct
EU (EC) Regulations

EU, EC, Guidance-Annex 19 Reference and Retention Samples
Issued 14 December 2005

Regulations • Regulatory
EU (EC) Regulations

EU, EC, Guidance-GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products
Annex 1 Consultation Document December 2020

Regulations • Regulatory
EU (EMA) CHMP

EU, EMA, Guidance-ICH guideline Q10 on pharmaceutical quality system
Effective June 2008

Regulations
EU (EMA) CHMP

EU, EMA, Guidance-Requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
Issued 20 September 2017

Regulations • Regulatory
EU (EMA) CPMP

EU, EMA, Guidance-ICH Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients
Guidances • Regulatory
EU (EMA) CPMP

EU, EMA, Guidance-In-Use Stability Testing of Human Medicinal Products
Adopted by CPMP February 2001

Guidances • Regulatory
EU (EMA) CVMP

EU, EMA, Guidance- Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
First Published: 13 October 2023, Consultation dates: 13 October 2023 to 05 January 2024

Guidances • Regulatory
EU (EMA) CVMP

EU, EMA, Guidance: Stability testing of existing active substances and related finished products
First Published 12 October 2007
EU (EMA) Quality

EU, EMA, Guidance-Declaration of storage conditions for medicinal products particulars and active substances (Annex)
Intended as an annex to stability guidelines and relates to marketing authorizations for all product categories. Last updated 19 November 2007.

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms
Step 5 dated 21 June 2017

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers
Questions and Answers, dated 23 July 2015

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH guideline Q8 (R2) on pharmaceutical development
Dated 22 June 2017

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Dated February 2002

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Dated July 1996

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH Q5E: Comparability of Biotechnological/Biological Products
For guidance on biotechnological/biological products subject to changes in their manufacturing process. Dated June 2005

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Dated May 2000

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients
Step 5 dated November 2000

Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-Quality of medicines questions and answers: Part 1
Guidances • Regulatory
EU (EMA) Quality

EU, EMA, Guidance-Quality of medicines questions and answers: Part 2
Guidances • Regulatory
FDA

FDA Notes on Shelf Life and Expiration Dating of Cosmetics
Notes for guidance

Guidances • Regulatory
FDA

Review of Post-Inspection Responses - From Federal Register
Current

Audits • Compliance • Regulations • Regulatory
FDA / Industry Panel

FDA’s Revised Proposal on Site-Specific Stability Data
Draft, March 31, 1999
ICH

International, ICH, Guidance-Draft Guidance, Stability Testing of Drug Substanced and Drug Product
Draft

Compliance • Guidances • Quality • Regulatory • SOPS
Internation (ICH) Q

International, ICH, Guidance-Q12 Annexes, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Final version, adopted on 20 November 2019

Guidances • Regulatory
International (ASEAN) ATSC

International, ASEAN, Guidance-Annex V: Stability Study and Shelf-life of Health Supplements
Version 1.0 (2013)

Guidances • Regulatory
International (ICH) M

International, ICH, Guidance-M10 Bioanalytical Method Validation and Study Sample Analysis
Final version, adopted on 24 May 2022

Guidances • Regulatory
International (ICH) M

International, ICH, Guidance-M10: Bioanalytical Method Validation and Study Sample Analysis (FAQs)
Document date: 11 November 2022

Guidances • Regulatory
International (ICH) M

International, ICH, Guidance-M4 The electronic Common Technical Document - eCTD v4.0
Guidances • Regulatory
International (ICH) M

International, ICH, Guidance-M4: The Common Technical Document
Guidances • Regulatory
International (ICH) Q

International, ICH, Concept Paper-ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
This is a concept paper endorsed by the Management Committee on 15 November 2018

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Annex 10: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
Formerly Q1F (withdrawn), this guidance was published as Annex 2 in the WHO Technical Report Series, No. 953, 2009

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q10: Pharmaceutical Quality System
Current Step 4 version dated 4 June 2008

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Current Step 4 Version Dated 1-May-2012

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q13: Continuous Manufacturing of Drug Substances and Drug Products
Draft version endorsed on 27 July 2021. Currently under public consultation.

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q1A(R2) Stability Testing of New Drug Substances and Products
Current Step 4 version dated 6 February 2003

Guidances • Regulations • Regulatory
International (ICH) Q

International, ICH, Guidance-Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products
Current Step 4 version dated 6 November 1996

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q1C: Stability Testing of New Dosage Forms
This version is dated 6 November 1996 and is an annex to the ICH Guideline on Stability Testing for New Drugs and Products.

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q1E: Evaluation for Stability Data
Current Step 4 version dated 6 February 2003

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q2 (R1): Validation of Analytical Procedures: Text and Methodology
Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q3A(R2): Impurities in New Drug Substances
Current Step 4 version dated 25 October 2006

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q3B(R2) Impurities in New Drug Products
Current Step 4 version dated 2 June 2006

Guidances • Regulatory
International (ICH) Q

International, ICH, Guidance-Q3C Impurities: Guideline for Residual Solvents
Current Step 4 version (R8) dated 22 April 2021

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