Common mistakes in validating package systems
It includes the qualification of systems and equipment. The goal of the validation is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved and monitoring of the system whilst in production. In general, an entire process is validated and a particular object within that process is verified.
The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.”Validation Master Plan:- It is important to draw up a summarized document that describes the whole project. List of critical processing parameters and critical excipients 9. Acceptance criteria From study, it can be stated that Process validation is a major requirement of c GMP regulation for finished pharmaceutical products. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production. In a guideline, validation is act of demonstrating and documenting that any procedure, process, and activity will consistently lead to the expected results. It has become common practice in the industry to develop a “validation master plan” (VMP). It is a key element in assuring that the quality goals are met. This document would usually include the qualification aspects of a project. Background/Prevalidation Activities Summary of development and tech transfer (from R&D or another site) activities to justify in-process testing and controls; any previous validations. List of equipment and their qualification status 5. Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Validation: an unconventional review and reinvention.