Description
This document is complementary to the ICH guidance entitled Text on Validation of Analytical Procedures (ICH Q2A), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the drug substance or drug product. In addition, the document provides an indication of the data that should be presented in a new drug application.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2development program for drug and biological products
analytical procedures for biological and biotechnological products
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Regulatory Activities
1Rule does not apply to products marketed under an NDA
Document Types
3Defines the standard of veterinary practice and limits for anesthetic regimens
Visual representation of impurity profiles in batches.
reproducibility data are not part of this dossier
Attributes
9Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
Performance characteristic to be validated
validation characteristic to provide a sound, overall knowledge of the capabilities
Performance characteristic assessed via linearity experiment
Closeness of agreement between a series of measurements from multiple samplings.; Performance characteristic measured by intermediate precision; Performance characteristic to be validated
Analytical procedure validation characteristic
Must be not more than the reporting threshold.
Evaluation of robustness and parameter ranges of analytical procedures; Development of a robust multivariate analytical procedure includes scientifically justified sample selection; Capacity of an analytical procedure to meet performance criteria during normal use.; Assessed using retention time models; Performance characteristic to be validated
Used for estimating detection and quantitation limits
Technical Details
Substances
6quantitative measurement of the major component(s) in the drug substance; changes in the synthesis of the drug substance
Stability of the analyte in the studied matrix; Specific chemical moiety being measured in a biological matrix.
assaying for the active or other selected component(s)
Suitably characterized materials used in validation studies
Differences in excipients may affect product stability
Components which may be expected to be present alongside the analyte.
Testing Methods
10sponsors should propose statistical methods that properly account for missing data
In the case of gas-chromatography, examples of typical variations are different columns and flow rate.
In the case of liquid chromatography, examples of typical variations are pH and mobile phase composition.
Visual evaluation may be used for non-instrumental methods.
Image quality metric assessment
The slope S may be estimated from the calibration curve of the analyte.
intended to ensure the identity of an analyte in a sample
Part of stability testing parameters
investigation of specificity should be conducted during the determination of impurities; discrimination established by spiking drug substance or drug product
For chromatographic procedures, which make up the majority of procedures used in tobacco chemistry
Processes
1integral part of many analytical procedures
Standards & References
External Standards
2See Pharmacopoeias for additional information on system suitability test parameters.
comparing test results to a second well-characterized procedure
Specifications
3Typical validation characteristics which should be considered; lowest amount of analyte in a sample which can be detected but not necessarily quantitated
system suitability parameters (e.g., resolution test) is established
Typical validation characteristics which should be considered; lowest amount of analyte in a sample which can be quantitatively determined
ICH References (4)
Validation of Analytical Procedures: Methodology
Text on Validation of Analytical Procedures
impurities in new drug substances; Referenced regarding impurities and polymorphism.
impurities in new drug products; Impurities in new drug products; Recommendations for genotoxicity studies and toxicological qualification; Impurities in New Drug Products; Qualification study(ies) as described in ICH Q3B
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- E11A Pediatric Extrapolation
- M15 General Principles for Model-Informed Drug Development
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Rare Diseases: Considerations for the Development of Drugs and Biological Products
- Q3C Impurities: Residual Solvents_2011
- Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry
- Q4B Annex 5: Disintegration Test General Chapter