ANALYTICAL METHOD DEVELOPMENT AND VALIDATION SERVICES
NLRC Laboratories offering analytical testing method development and validation services according to the International Conference on Harmonization (e.g., ICH Q2(R1), and FDA, USFDA, EU, AOAC, NF T90-210, Citac /Eurachem guidelines and ISO Standards that verify products against manufacturing and quality specifications.
Analytical method development and validation plays a crucial role in products analysis and ensuring the accuracy, reliability, and quality of analytical methods used in various industries and applications such as biotechnology, environmental analysis, food & beverages, materials science, and other regulated sectors where product quality and safety are critical. NLRC Laboratories have state-of-the-art instruments that are precisely calibrated and ready for testing. and providing method development and validation services to our clients.
Method Development Services
- Analytical Method Development:Customized development of analytical methods for the accurate and precise measurement of specific components or properties in various samples.
- Method Optimization:Fine-tuning and improving existing methods for enhanced performance, sensitivity, and efficiency.
- Analyte Characterization: Comprehensive analysis and characterization of analytes to determine the most suitable methods for their measurement.
- Sample Preparation Optimization: Development of sample preparation techniques that ensure sample integrity and analyte stability.
Method Validation Services
- Method Validation Protocol Development: Creation of validation plans and protocols tailored to the specific requirements of clients and regulatory agencies.
- Accuracy and Precision Assessment: Evaluation of methods to ensure accuracy and precision in quantifying analytes.
- Specificity Testing: Testing to verify the method's ability to differentiate the analyte of interest from other components in the sample.
- Sensitivity and Detection Limits Determination: Assessment of the method's sensitivity and limits of detection.
- Linearity and Range Verification: Confirming the linearity and dynamic range of the method.
- Robustness Testing: Evaluating the method's robustness against minor variations in conditions.
Our method validation services play a crucial role in ensuring the quality and compliance of analytical methods, contributing to the overall reliability of analytical results and the integrity of products in regulated industries.
We also provide consulting and training programs for laboratory personnel to ensure that the validated methods are executed correctly and consistently. By incorporating a culture of continuous improvement, NLRC can enhance the effectiveness of method development and validation processes, ensuring that analytical methods remain accurate, compliant, and responsive to evolving industry needs. Regular assessments, feedback mechanisms, and a commitment to staying current with industry trends are key components of successful continuous improvement initiatives.
What are the preexisting regulations surrounding the validation of analytical methods?
- ISO 17025:2017: General requirements for the competence of testing and calibration laboratories
- FDA Guidance for Industry (July 2015): Analytical Procedures and Methods Validation for Drugs and Biologics
- ICH Q2 (R1): Validation of analytical methods: text and methodology
- NF V03-110 May 2010: Analysis of foodstuffs - Protocol of characterization for the validation of a quantitative method of analysis by construction of an accuracy profile
- Analytical validation guide: SFSTP commission report – I methodology
- ISO 5725-1:1994: Accuracy (trueness and precision) of measurement methods and results
- Part 1: General principles and definitions
- Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
- FDA Guidance for Industry (July 2015): Analytical Procedures and Methods Validation for Drugs and Biologics
- NF T90-210 May 2009: water quality- protocol for the initial method performance assessment in a laboratory
- Citac / Eurachem Guide: Quality control in Analytical Chemistry
