Process Validation

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

Too much or too little control can actually lead to the same result.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

From last-minute product inserts to putting out fires, close calls are a common occurrence.

Sharing too much-or too little-information can have disastrous onsequences.

Directors and staff miss the mark when it comes to following procedures.

Blame it on cafeteria gossip, outdated procedures, and major miscommunication.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

Like life, the workplace also can have many surprises.

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

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

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

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

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.

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.

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

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The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

GMP agents report on old products, aseptic violations, and unexpected emotions.

Operational excellence awaits, but only if you can implement PAT successfully.

The source of a problem reveals itself after some investigation, or it may crash down on you.

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.

GMP experts act fast to resolve some unusual and difficult problems.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

Readers give advice on their best approach to handling (batch) rejection

When accusations fly: 'Tis better to give than to receive.