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 ...

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, ...

Process validation is an extension of biologics development processes. When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth ...

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 ...

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 ...

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 ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Vivek Yadav, an engineering manager from ...