Method Validation Of Pharmaceutical Products
Ensuring accurate, reliable, and regulatory-compliant analytical methods for pharmaceutical and cosmetic testing.
- A pharmaceutical product has to undergo various types of assessing procedures, one of which is the ‘analytical method.’ The analytical procedure includes ‘identification test’, ‘assaying of drug substances & pharmaceutical products,’ ‘quantity test for the content of impurities,’ ‘dissolution testing,’ and ‘determination of particle size.’
- When any of these analytical methods are applied to the product, the Good Manufacturing Practices (cGMPs) demands the validation report.
- The report supports drug characterisation, quality control, and manufacturing batch records. Further, the ‘analytical test method validation’ report provides a documented process showing that the test procedure is suitable for its intended purpose. The result works as evidence of the method’s performance & makes sure of the quality and reliability of results.
- As the name suggests, validation of the pharmaceutical product is a method that ensures and validates the analytical procedure that has been performed on the product.
- Once the analytical procedure is conducted, it becomes mandatory for the companies to assure that their applied procedure of manufacturing drugs will consistently produce the intended result with a high level of accuracy.
- The validation process involves certain parameters that make the method acceptable with the addition of statistical tools. As a pharmaceutical industry owner, the method of validation is crucial to ensure the product quality in terms of therapeutic efficacy and patient safety, both.
WHY choose ANACON Laboratories for Method Validation
- We offer the best and most trusted testing services for validation testing for analytical testing. At Anacon Laboratories, we validate the analytical method by establishing a protocol containing well-defined procedures and criteria. Our team constructs a well-planned and well-organized protocol, thereby resulting in a fast and accurate method validation procedure.
- We follow stringent guidelines set by the regulatory bodies to deliver flawless test results. Our team takes into account every tiny detail, and we have set in place state-of-the-art technology and infrastructure in our laboratory.