Does cGMP regulations require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? No. Neither the cGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process. The current FDA guidance on APIs (see ICHQ7) also…
Before the answer to the above question first, we should be aware of validation. What is Validation? Validation is documented evidence that ensures that a process or procedure consistently produces a product with the same quality standards. Validation has great importance in pharmaceutical industries because, for every product manufacturing, we conduct a validation…
Process validation is a critical and mandatory step in the pharmaceutical industry to ensure the consistent production of high-quality pharmaceutical products. It is a systematic approach used to confirm that a manufacturing process consistently produces a product that meets its predetermined specifications and quality attributes. Process validation helps in ensuring patient safety and product…
