Drug Development

Articles

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

Is FDA's Draft Process-Validation Guidance a Mixed Blessing?

Uncovering the root cause of contamination and leveraging the collaborative learning loop of QbD -Aegis Whitepaper

An ounce of contamination usually leads to a mountain of investigation.

Bio Burdens

Some GMP agents seem to find a way to squander time, money, and common sense.

Wasting Away

Short-term problems in software or hardware lead to long-term manufacturing troubles.

Operator Error

Guy Villax is Chief Executive Officer of Hovione FarmaCiencia SA and a member of the Board of the EFCG.

In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.

Substandard APIs: we must tackle the problem together

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.

Why we need mass serialization — now!

Process steps, GMP documents, a purification vessel, and validation seem to disappear.

Missing Something?

With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.

The FDA's new direction

Warren Charlton is a consultant at WHC Bio Pharma Technical Services, PO Box 20309, Greenville, NC 27858, tel. 252.327.4733, fax 252.756.4733.

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

Process and Scaling