Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

Overview: The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

Machine and process troubleshooting are the most important factors in controlling process and reducing defects. Poorly performing presses lead to process variance and uncontrollable scrap events, and ...

Overview: The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of ...