Building a goal oriented pathway into which proper design precedes development activities for various Analytical and Test Methods as a means for building Quality into the method right from the start is extremely crucial. This is emphasized by The American Chemical Society (ACS), and is the nucleus of pharmaceutical Quality by Design (QbD).
So, how does one understanding QbD? QbD is a systematic approach towards development that is built on a set of predefined objectives. It informs a proper and thorough understanding of product and process, and process control, all of which are built on the edifice of sound science and quality risk management. QbD has been acquiring a position of preeminence in enhancing the quality, safety and effectiveness of the drugs being supplied to the patient. Its potential in bringing about substantial improvements into the quality performance of the manufacturing process is also gaining ground. Read more
Validation is aligned to QbD
The indispensability of Validation as a tool in demonstrating that the desired method is appropriate and sufficient for the purpose it is meant to serve is emphasized by the ACS. In order to achieve this, the organization has to build a risk based strategy for developing and applying these methods for their intended purpose during the entire lifecycle of these methods.
Meeting regulatory requirements through a risk based strategy
Know real-life analytical problem solving and Method Development methods. how to create an appropriate Validation schematic and the Validation Protocol.
While imparting an understanding of the fundamentals of Quality Assurance, Quality Control, and analytical methods validation, how can use these tools to enhance the quality of their analytical data submissions that fully company with the respective and relevant FDA, WHO and OECD regulatory compliance directives.
All the steps about conceptual framework which helps build documentation of practical applications that lead to data handling, Data Integrity, Validation Protocol and other documentation, even as all of them meet regulatory requirements.
An understanding of the extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC, etc., and the other aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, as well as statistical tools, SQC, SPC for processing and monitoring of analytical data; are part of the way to learning and explore your knowledge for better results.
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