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 ...

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 ...

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 ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official ...

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals. It is now possible, as demonstrated by Janssen (1), for drug ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...