Process Validation

Even when all is well at the facility, one must expect the worst while braving the elements.

Only the strong survive when it comes to pharmaceutical packaging and shipping.

International trade can be great for business, but breaking border laws can put one in hot water.

Meticulous system configuration can prevent machines from taking over.

Careful attention to detail will help to prevent valuable assets from "melting" away.

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

Failure to disclose info may work sometimes, but eventually every question will be answered.

In a world where product recalls can mean the end of a company, all batches must be perfect.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

Technology may expedite operations, but the absence of the human element could cost dearly.

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Careful mixing during a product's distillation can help avert trouble from a strong concoction.

Letting contamination build up can cause multiple headaches.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

Visiting a new site or going down memory lane may not get you where you want to go.

Getting an answer is easy-asking the right question is apparently more difficult.

Sometimes, there are just too many cooks in the kitchen.

Many factors affect research results.

In any industry, inspections can be a pain, and pharma is no exception.

Just when things seem to be looking up, the unexpected problem occurs.

Taking care to note, file and re-check information can save one from future mishaps.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Sometimes doing what you think is right ends up being completely and utterly wrong.

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

From disagreement to denial, being cordial about quality control can be challenging.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.