CEI-MS-14 — references

§7References

§7.1Normative references

The following are normative for this standard: compliance with the standard requires compliance with them^{[1,2,3,4,5,6]}.

• ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products — ICH Harmonised Tripartite Guideline, 1999
• General Chapter ⟨1225⟩ Validation of Compendial Procedures — United States Pharmacopeia — National Formulary (USP–NF), 2024
• ICH Q2(R2) Validation of Analytical Procedures — ICH Harmonised Guideline, 2023
• ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories — ISO/IEC Standard, 2017
• General Monograph 2034 Substances for Pharmaceutical Use — European Pharmacopoeia, 2023
• WHO Expert Committee on Specifications for Pharmaceutical Preparations — Fifty-seventh report — WHO Technical Report Series, 2023

§7.2Informative references

This standard cites no informative reference.

§7.3Related standards

• CEI-MS-15 — Protocol for independent third-party verification of a supplied preparation

Numbered reference list

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
2. United States Pharmacopeial Convention. General Chapter ⟨1225⟩ Validation of Compendial Procedures. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
3. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q2(R2) Validation of Analytical Procedures. ICH Harmonised Guideline 2023;Step 4 version, 1 November 2023. identifier not held by the Institute
4. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
5. European Directorate for the Quality of Medicines & HealthCare. General Monograph 2034 Substances for Pharmaceutical Use. European Pharmacopoeia 2023;11th edition. identifier not held by the Institute
6. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations — Fifty-seventh report. WHO Technical Report Series 2023;No. 1044. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.