Autoclave Validation Risk: Uneven temperature distribution could lead to incomplete sterilization. QRM Application: Conduct risk assessments for load configurations and identify critical spots for temperature sensors to ensure uniform heat distribution. Cold Chain Validation Risk: Temperature excursions during storage or transport might compromise product quality. QRM Application: Use risk-based mapping to monitor high-risk areas (e.g.,…
3 Types of Water System Validation: Water System Validation Phase I Water System Validation Phase II Water System Validation Phase III 1. Water System Validation Phase I The time period for phase I shall be 2 to 4 weeks (14 days minimum) to Examine the system thoroughly. During this time, the operation must operate…
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…
In the pharmaceutical industry, calibration, validation, and qualification are crucial processes that ensure the accuracy, reliability, and compliance of instruments, methods, and processes used in drug development, manufacturing, and quality control. While these terms may seem similar, they have distinct meanings and purposes within the pharmaceutical context. Calibration Calibration in the pharmaceutical industry refers…
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…
