Supplier validation or verification, also known as vendor validation, is the process of confirming that a supplier/vendor of your company agree to contract with continuous quality supply maintaining GMP and GDP. Global sourcing and supply of Active Pharmaceutical Ingredients (APIs) and finished medicinal products, from source to end customer, MUST have robust systems…
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…
What are the 4 types of validation? A) Prospective validation B) Retrospective validation C) Concurrent validation D) Revalidation How many stages for process validation life cycle? Process Design: Process design is the first stage of the process validation life cycle approach. Design the manufacturing process of the subject product based on the knowledge gained…
WHAT IS VALIDATION? EU GMP – it is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results. WHAT IS QUALIFICATION Performed to establish evidence that process equipment and ancillary systems are capable of operating within established…
1. Calibration This involves testing the accuracy of the pH meter by measuring solutions with known pH values. The pH meter should provide readings that are within an acceptable range of the known values. 2. Linearity This test determines if the pH meter provides consistent and accurate readings across a range of pH values….
Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the USP Pharmacopeia and the National Formulary constitute legal standards. The cGMP regulations [21 CFR 211.194(a)] require that…
Computer system validation (CSV) in the pharmaceutical industry refers to the process of ensuring that computer systems used in various critical functions, such as manufacturing, quality control, and data management, are operating in a controlled and consistent manner. CSV is essential for ensuring data integrity, patient safety, and compliance with regulatory requirements. The CSV…
