ICH Q2
The International Conference on Harmonisation (ICH) is an expert working group with representation from the United States, European and Japanese Pharmacopoeias.
In their harmonized tripartite guideline ICH Q2, Validation of Analytical Procedures: Text and Methodology, they outline characteristics to consider during validation of the four most common types of analytical procedures:
- Identification tests
- Quantitative tests for impurity content
- Limit tests for the control of impurities
- Quantitative tests of the active moiety in samples of a drug substance/product or other selected component(s) in a drug product
ICH Q2 differentiates between validation characteristics required for analyzers used for limit testing of impurities and those used for quantitative analysis of impurities.
Typical validation characteristics include:
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The final draft of ICH Q2 is recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.
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Helpful Links
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Industry Standards
- USP<643>
- 21 CFR Part 11 - Data Integrity
- Maintaining Data Integrity: Understanding FDA ALCOA Guidance
- European Pharmacopoeia EP 2.2.44
- EU GMP Annex 1
- EU GMP Annex 11
- ICH Q2
- ISO 21501
- ISO Regulations
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IVD-Regulation (IVDR)
- IVDR compliant instruments*
- IVDR compliant software*
- IVDR compliant reagents
- E-book
- Future proofing your flow cytometry panel under IVDR
- In-house IVD FCM panel or not: it depends
- Building IVDR compliant panels for haematological disorders
- Impact of the new EU IVD-Regulation on the daily life of the clinical Flow cytometry laboratory webinar
- Laboratory Developed Test (LDT) vs IVD Validation Workflow
- Meet the Expert — Maurizio Suppo, PhD
- Potential Impacts of EU IVD-Regulation on the Clinical Flow Cytometry Lab
- IVD-R Annex I Global Safety and Performances Requirements (GSPR). A New Set of Requirements for Clinical Laboratories Performing Laboratory Developed Tests
- IVD-R: Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements
- Regulatory Entities: Separation with Cooperation
- USP 1046
- USP 1047
- USP <788>, <787> and EP2.9.19
- USP <790>
- ISO 11171 Standard
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ISO 14644: Airborne Particulate Cleanliness in Cleanrooms and Clean Zones
- Particle Counters Designed to Support ISO 14644-1 and ISO 21501-4 Requirements
- 2015 Published Standards for ISO 14644
- ISO 14644-1 Classification of Air Cleanliness by Particle Concentration
- ISO 21501-4: Light Scattering Airborne Particle Counter for Clean Spaces
- Particle Counting: Terms and Formulas
- USP <787>