Method validation is a critical aspect of the pharmaceutical industry, ensuring that analytical methods used to test drug products are accurate, reliable, and consistent. Data from the validation process are required to confirm the analytical process for a specific test. Method verification or validation allows the results from the intended analytical process to establish the consistency, performance, and reliability of the method.
Method validation typically involves:
- Selecting and optimizing analytical procedures to achieve optimum precision.
- Evaluating the performance characteristics like linearity, robustness, and accuracy.
- Ongoing monitoring to ensure suitability for its intended use.
Method validation is one of the most significant steps in securing the efficiency and safety of pharmaceutical products in the market. In reference to the current USP validation and verification parameters (referenced in the USP General Chapter <1225> “Validation of Compendial Procedures”) ensure that analytical procedures are reliable and provide accurate and precise results. Validation processes typically require regulatory bodies, such as the FDA and EMA.
PLS Analytical is the world leader in responsible method verification processes for pharmaceutical products.
We are fully committed to producing ethically tested data that helps us bring effective personal care, pharmaceutical, and therapeutic products to the market. We stand for a wide range of testing services from clinical safety, efficiency verification, sterility, and others.
Importance Of Method Validation/Verification
Method validation or verification in pharmaceutical companies helps to:
Helps with the specificity of an analytical procedure, according to the parameters of USP verification. Specificity distinguishes the analyte of interest from other components in the sample.
Identify and control sources of variability in the testing process.
Provides a standardized approach to testing, resulting in keeping consistency and comparability of the results of the analytical procedures.
Minimizes the risks of product recall or other regulatory actions due to inadequate testing or inaccurate results.
Demonstrates compliance with regulatory guidelines, which ensures the safety and efficiency of pharmaceutical products for patients.
All our testing methods are adhered to under cGMP, following strict FDA and ICH guidelines.