| ANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF-LIFE OF TRADITIONAL MEDICINES | http://asean.org/storage/2017/09/ASEAN-Guidelines-on-Stability-and-Shelf-Life-TM-V1.0-with-disclaimer.pdf |
| ANVISA RDC N° 318/2019 Criteria for conducting Stability Studies for APIs and Drug Products, except for biological, and provides other arrangements' (6 November 2019) | http://abracro.org.br/pdfs/RDC-318-06Nov2019-estudos-estabilidade_EN.pdf |
| ASTM F-1980-16 Std Guide Accelerated Aging of Sterile Barrier Systems for Med Devices | https://www.astm.org/Standards/F1980.htm |
| ASTM D-4332-14 Practice for Conditioning Containers, Packages, or Packaging Components for Testing | https://www.astm.org/Standards/D4332.htm |
| ASTM-F-2097-16 Guide for Design and Evaluation of Primary Packaging for Medical Products | https://www.astm.org/Standards/F2097.htm |
| CHPA Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an NDA/ANDA | https://www.chpa.org/public-policy-regulatory/voluntary-codes-guidelines/guideline-stability-testing-nonprescription-otc |
| China (NMPA) Stability Studies of Pharmaceutical Packaging Materials in China | https://www.westpharma.com/en/blog/2019/May/stability-studies-of-pharmaceutical-packaging-materials-in-china# |
| Development of the Chinese Pharmacopoeia 2020 Edition General Chapters: A Review | https://www.sciencedirect.com/science/article/pii/S2095177921000496 |
| EMA Guideline: Stability Testing of Existing Active Substances and Related Finished Products 2007 | http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003466.pdf |
| EMA Guideline on stability testing for applications for variations to a marketing authorisation | http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/04/WC500164972.pdf |
| EMA Note for Guidance on In-Use Stability Testing of Human Medicinal Products March 1 2001 | https://www.ema.europa.eu/documents/scientific-guideline/note-guidance-use-stability-testing-human-medicinal-products_en.pdf |
| 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): | https://www.ema.europa.eu/en/declaration-storage-conditions-medicinal-products-particulars-active-substances-annex |
| EMA ‘Quality of medicines questions and answers: Part 2’ | https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/qa-quality/quality-medicines-questions-answers-part-2 |
| EMA Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management) | https://www.ema.europa.eu/en/ich-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management |
| EMA Guideline on the requirements for the chemical & pharmaceutical quality documentation concerning investigational medical products in clinical trials | https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-chemical-pharmaceutical-quality-documentation-concerning-investigational_en.pdf |
| EP 25A Evaluation of Stability of In-Vitro Diagnostic Reagents; Approved Guideline | https://clsi.org/media/1424/ep25a_sample.pdf |
| EU Regulation Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 6: Quality Control Sections 6.26-6.36 | https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-chemical-pharmaceutical-quality-documentation-concerning-investigational_en.pdf |
| EU Regulation Annex 1 2020 Rev 2 for comment Manufacture of Sterile Products | https://ec.europa.eu/health/medicinal_products/consultations/2020_sterile_medicinal_products_en |
| EU Regulation Annex 19 Reference and Retention Samples 2005 | https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf |
| FDA 1998 Withdrawn Guidance for Industry Stability Testing of Drug Substances and Drug Products | http://academy.gmp-compliance.org/guidemgr/files/1-7-3.PDF |
| FDA Draft Guidance Quality Considerations for Continuous Manufacturing Products | https://www.fda.gov/media/121314/download |
| FDA Guidance for Pharmaceutical Quality Control Labs (July 1993) | https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793 |
| FDA Guidances for Industry “ANDAs: Stability Testing of Drug Substances and Products” (June 2013) | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-stability-testing-drug-substances-and-products |
| FDA Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf |
| FDA Guidance for CMC Information for Human Gene Therapy INDs | https://www.fda.gov/media/113760/download |
| FDA Guidance CMC Changes to an Approved Application: Certain Biological Products | https://www.fda.gov/media/109615/download |
FDA Guidance Immediate Release Solid Oral Scale-Up & Postapproval Changes CMC In-VitroDissolution & In-Vivo Bioequivalence Documentation
| https://www.fda.gov/media/70949/download |
| FDA Guidance for Industry Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products | https://www.fda.gov/media/70985/download |
| FDA Guidance In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products | https://www.fda.gov/media/102469/download |
| FDA Guidance for Industry and FDA Staff CGMP Requirements for Combination Products | https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm429304.pdf |
| FDA Guidance for Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-and-closure-system-integrity-testing-lieu-sterility-testing-component-stability-protocol |
| FDA Guidance Effects of COVID-19 on Meetings and User Fees Q&As | https://www.fda.gov/media/138358/download |
| FDA Guidance Expiration Dating and Stability Testing for Human Drug Products | https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/expiration-dating-and-stability-testing-human-drug-products |
| FDA Guidance Methods, Method Verification and Validation | https://www.fda.gov/media/73920/download |
| FDA Guidance M10 BioAnalytical Method Validation and Study Sample Analysis | https://www.fda.gov/media/162903/download |
| FDA Investigations Operations Manual (2021) | https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual |
| FDA Investigating Out of Specification Test Results for Pharmaceutical Production | https://www.fda.gov/media/71001/download |
| FDA Investigating Out of Specification Test Results for Pharmaceutical Production Lvl2 | https://www.fda.gov/media/158416/download |
| FDA Drug Compliance Program Manual | https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-compliance-programs |
| FDA Expiration Dating and Stability Testing for Human Drug Products (1985/2014) | https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/expiration-dating-and-stability-testing-human-drug-products |
| FDA (QSIT) Quality Systems Inspection Technique process | https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/quality-systems |
| FDA Guidance for Industry Drug Products, including biological products, that contain nanomaterials April 2022 | https://www.fda.gov/media/157812/download |
| Requirements for Combination Products | https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents |
| Review and Update of Device Establishment Inspection Processes and Standards | https://www.fda.gov/media/139466/download |
| Health Canada Guidance for Industry Stability Testing of Existing Drug Substances and Products. 2003 (superceded by 2017 Quality CMC) | http://publications.gc.ca/collections/Collection/H49-183-2003E.pdf |
| Health Canada Guidance Document: Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDAs) 2017 | https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-document-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.pdf |
| Health Canada Guidelines for environmental control of drugs during storage and transportation (GUI-0069) | https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guidelines-temperature-control-drug-products-storage-transportation-0069.html |
| ICH Q1A (R2) Stability Testing of New Drug Subtances and Products | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf |
| ICH Annex 10 Stability testing of api's & fin pharma prod. (See WHO Annex 10) | https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS1010annex10.pdf?ua=1 |
| ICH Q1B Photostability Testing of Stability Testing of New Drug Subtances and Products | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1B/Step4/Q1B_Guideline.pdf |
| ICH Q1C Stability Testing of New Dosage Forms | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1C/Step4/Q1C_Guideline.pdf |
| ICH Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1D/Step4/Q1D_Guideline.pdf |
| ICH Q1E Evaluation for Stability Data | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1E/Step4/Q1E_Guideline.pdf |
| ICH Q1E Evaluation for Stability Data (Presentation) | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1E/Presentation/Q1E_Presentation.pdf |
| ICH Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV (withdrawn) | https://www.ich.org/page/quality-guidelines; https://database.ich.org/sites/default/files/Q1F_Explanatory_Note.pdf |
| ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf |
| ICH Q3A (R2) Impurities in New Drug Substances | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf |
| ICH Q3B (R2) Impurities in New Drug Products | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf |
| ICH Q3C (R6) Impurities: Guideline for Residual Solvents | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Q3C__R6___Step_4.pdf |
| ICH Q3C (R6) Impurities: Guideline for Residual Solvents | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Concept_papers/Q3C_Concept_Paper.pdf |
| ICH Q3C (R6) Impurities: Guideline for Residual Solvents | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/ICH_Q3CR6_Step4_09Jan2017.pdf |
| ICH Q3C (R7) Impurities: Guideline for Residual Solvents (revision of R6 in progress for 3 new solvents) | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Q3C-R7EWG_WorkPlan_2018_0221.pdf |
| ICH Q3D Guideline for Elemental Impurities | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf |
| ICH Q3D (R1) Guideline for Elemental Impurities | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D-R1EWG_Document_CadmiumPDEGuideline_Step2_2018_0518.pdf |
| ICH Q3D (R2) Guideline for Elemental Impurities Final Concept Paper 2016 | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_R2__EWG_final_Concept_Paper_Cutaneous_and_Transdermal_1Sep2016.pdf |
| ICH Q3D Final Concept Paper Q3D: Elemental Impurities IWG | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_IWG_Final_Concept_Paper_October_21_2014.pdf |
| ICHQ3D Training; Implementation of Guideline for Elemental Impurities | See previous line for preliminary link |
| ICH Q4-Q4B Pharmacopoeias | See http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html for listing of multple links |
| ICH Q5C Stability Testing of Biotechnological/Biological Products | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5C/Step4/Q5C_Guideline.pdf |
| ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf |
| ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New DS and DP Chemical Substances | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf |
| Decision Trees for Q6A | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Decision_Trees.pdf |
| ICH Q6B Specifications: Test Procedures and Application Criteria for Biotechnical/Biological Products | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf |
| ICH Q7 Good Manufacturing Guide for Active Pharmaceutical Ingredients | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf |
| Q&A on ICH Q7 – Good Manufacturing Practice Questions and Answers Document | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/ICHQ7_Q_AStep4Presentation_2017_0821.pdf |
| ICH Q8 Pharmaceutical Development | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf |
| Q8, Q9, Q10 Training Program | http://www.ich.org/products/guidelines/quality/training-programme-for-q8q9q10/presentations.html |
| ICH Q9 R1 Quality Risk Management | https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2022_1219.pdf |
| Q9 Briefing Pack | http://www.ich.org/products/guidelines/quality/q9-briefing-pack/briefing-pack.html |
| ICH Q10 Pharmaceutical Quality System | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf |
| ICH Q10 - Pharmaceutical Quality System - Briefing Presentation | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Presentation/Q10_General_Presentation.pdf |
| ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotech/Biological Entities | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf |
| Questions and Answers for Q11 Development and Manufacture of Drug Substances | http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11IWG_Step4_QA_2017_0823.pdf |
| ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management | https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf |
| ICH Q12 Annex for Tech and Regulatory Considerations for Pharmaceutical Product Life Cycle Management | https://database.ich.org/sites/default/files/Q12_Annexes_Step4_2019_1119.pdf |
| ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products 3/2023 | https://www.fda.gov/media/165775/download |
| ICH Q14 Analytical Procedure Dev & Rev Q2(R1) | https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf |
| ICH M4 The Common Technical Document | https://www.ich.org/page/ctd |
| ICH M4 The electronic Common Technical Document -ectd-v40 | https://ich.org/page/ich-electronic-common-technical-document-ectd-v40 |
| ICH M10 BioAnalytical Method Validation and Study Sample Analysis | https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf |
| ICH M10 BioAnalytical Method Validation and Study Sample Analysis FAQ's | https://database.ich.org/sites/default/files/M10_Guideline_FAQs_2022_1111_0.pdf |
| IPEC-Americas Position Paper Conducting Accelerated Stability on Excipients | https://ipecamericas.org/sites/default/files/IPEC%20Paper%20on%20Accelerated%20Stability_FINAL.pdf |
| IPEC Excipient Stability Program Guide 2010 | https://www.gmp-compliance.org/files/guidemgr/100311_IPECStabilityGuide-Final.pdf |
| IPEC Safety Guide for Pharmaceutical Excipients (2021) | https://www.ipec-europe.org/uploads/publications/2021-ipec-safety-guide-f-1643969102.pdf |
| ISO 11607-1 Section 6.4 Stability Testing | https://www.iso.org/obp/ui/#iso:std:iso:11607:-1:ed-1:v1:en |
| ISO 23640:2015 Evaluation of stability of in vitro diagnostic reagents | https://shop.bsigroup.com/ProductDetail/?pid=000000000030326409 |
| ISO 21973:2020: Biotechnology — General requirements for transportation of cells for therapeutic use. International Organization for Standardization. Jun. 2020 | https://cdn.standards.iteh.ai/samples/72326/eced53db37d948afaca36690e8153a94/ISO-21973-2020.pdf |
| ISPE Baseline Guide Vol 5 Commissioning & Qualification 2nd edition | https://ispe.org/publications/guidance-documents/baseline-guide-vol-5-commissioning-qualification-2nd-edition |
| ISPE Good Practice Guide-Controlled Temperature Chambers 2nd edition | https://ispe.org/publications/guidance-documents/ispe-good-practice-guide-controlled-temperature-chambers-2nd-edition |
| MHRA Inspectorate Blog Temperature Mapping-an introduction GDP Guide 3.2.1 | https://mhrainspectorate.blog.gov.uk/2016/07/14/temperature-mapping-an-introduction/ |
| PDA Tech Rpt 53:Guidance for Industry:Stability Testing to Support Distribution of New Drug Products | https://store.pda.org/TableOfContents/TR53_TOC.pdf |
| PIC/S Guidance to Good Manufacturing Practice for Medicinal Products-ANNEXES | https://picscheme.org/docview/4590 |
| PIC/S Website | https://picscheme.org/en/news?itemid=62 |
| PIC/S GMP Inspection Reliance Guidance Helping Global Agencies | https://redica.com/pharma-pic-s-gmp-inspection-reliance-guidance-helps-global-agencies-during-pandemic/ |
| USP 1207 Sterile Product Packaging-Integrity Evaluation | http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1207.html |
| US Regulation 21 CFR 211.166 Stability testing | https://www.govinfo.gov/content/pkg/CFR-2011-title21-vol4/pdf/CFR-2011-title21-vol4-sec211-166.pdf |
| US Regulation 21 CFR 820 Medical Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 |
| US Regulation CGMP Compliance Considerations for Combination Product Manufacturing- Office of Manufacturing Quality, CDER/OC | https://www.fda.gov/media/102786/download |
| WHO Annex 2 to WHO Technical Report Series, No. 953 ‘Stability conditions for WHO Member States by Region (August 2018) | https://www.who.int/medicines/areas/quality_safety/quality_assurance/StabilityConditionsTable2updatedAugust2018.pdf?ua=1 |
| WHO Annex 4 General Guidance on Hold-time Studies | https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex4-TRS992.pdf?ua=1 |
| WHO Annex 8 ‘Points to consider for setting the remaining shelf-life of medical products upon delivery | https://www.who.int/docs/default-source/medicines/who-technical-report-series-who-expert-committee-on-specifications-for-pharmaceutical-preparations/trs1025-annex8.pdf?sfvrsn=dfb3eca3_2&download=true |
| WHO Annex 9 Guidance to storage & transport of time/temp sensitive pharma products | https://www.who.int/medicines/areas/quality_safety/quality_assurance/ModelGuidanceForStorageTransportTRS961Annex9.pdf?ua=1 |
| WHO Qualification of Shipping Containers Annex 9 Tech suppliment to Rpts 961 (2011) | https://www.who.int/biologicals/expert_committee/Supplement-13-TS-container-qual-final-ECSPP-ECBS.pdf |
| WHO Annex 10 - Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (Final version 2018) | https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS1010annex10.pdf?ua=1 |
| WHO Establishing stability of in vitro diagnostic medical devices 2017 | http://www.who.int/biologicals/expert_committee/ECBS_2017_BS2304_In_vitro_diagnostic_medical_devices.pdf |
| WHO Rpt on Consultation on regional guidelines/stability studies of medicines & biologicals | http://apps.who.int/iris/bitstream/handle/10665/258560/WHO_EM_EDB_081_E_en.pdf?sequence=1&isAllowed=y |
