Method validation is an important measure to gauge safety and feasibility, especially in drug testing. Bioanalytical method validation offers documented and reliable proof of the performance of a drug. The continuous monitoring measures the quality of the method validation. This process's irregular performance can result in delays in product approval, complete scrapping of the development, or cause regulatory delays in commercialization. Therefore, there are certain Dos and Don'ts that one must follow while carrying out method development and validation so that such a scenario does not arise.
1. Do not ignore the following critical questions.
• Is this method for the release of raw material?
• Is this method for in-process control?
• Is this method for testing of the final product release?
• What is the route of administration for this product?
• What is the maximum daily dose for this product?
• How long does the drug product's administration take?
• What are the crucial components that need to be monitored for each sample of the product?
• What are the specifications?
• Does the compound have any genotoxic impurities?
• What is the impurity profile?
You must always have proper solutions to all these issues before deciding upon a method validation system.
It would be best if you always prepared for an analytical review of all the techniques developed in the process. The peer review, the Quality Analytics review, and the regulatory authority will validate these methods. If your analytical method development has been carried out effectively, this will ensure the optimum utilization of your lab resources. It will also help in validating the methods in each step forward in the process. If it presents specific errors or requires changes, you must make them in time and document them before moving forward in the next step of the validation process.
If the initial research of the product long with the method are looking viable, the next step is to optimize the method. There are various ways to optimize your method, such as improving the specificity of the method, gauging the sensitivity of the process, and focusing on the solution's stability. You can also develop a system for suitable determination. A perfectly optimized analytical method will become the spine of the regulatory submission as it will offer enhanced yield and productivity.
1. The chosen analytical procedure must exhibit demonstratable validation for its suitability to the product.
2. All analytical procedure requires validation irrespective of their stability.
3. The procedure must follow good laboratory practices and guidelines for the transfer of technology wherever it is applicable during the process of validation and organization of the analytical method validation.
4. The R & D department's validation should be carried out before being turned to the Quality Control unit for further assessment.
Scientifically sound analytical methods that are agreed upon and validated adequately with the regulatory authority in mind become the foundation for thriving manufacturing and regulatory approval and reliable and effective drugs.
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