Hundreds of Bugs Crawling in API Processing Areas? – cGMP Inspection Disaster

Hundreds of Bugs Crawling in API Processing Areas? – cGMP Inspection Disaster

April 3rd, 2013 // 4:35 pm @

A recent warning letter issued by the FDA to Asada Milling, an active pharmaceutical ingredient supplier based in Japan, may prompt you to ask whether a drug in which you have any type of  interest contains their products. Why? The list of violations is long, serious and disturbing. Consider the following deviations from good manufacturing practices that were noticed last October by the FDA:

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There was a notable failure to maintain and clean manufacturing equipment and facilities. For instance, an inspection found manufacturing equipment was corroded, rusted, had chipped paint and was coated with an unidentified white powder. There was also powder seen on the equipment, floors and walls of the mixing rooms, which could lead to a cross-contamination of manufactured products.

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An FDA investigator observed hundreds of insects in the insect catchers located in the processing areas, and this occurred one month after a pest control report noted an excessive number of bugs in the same vicinity. Presumably, Asada was not worried because the catchers appeared to be working and grabbing all those insects before they could crawl into the finished product.

What else? The quality unit lacked quality. How so? There was a failure to review, release or reject finished API products, and a failure to perform annual quality product reviews. And there were no procedures for reviewing process validation, release of raw materials and to reject or approve batch records. There was also no system for calibrating critical equipment or training employees.

What else? A few basic procedures were overlooked, such as establishing written procedures pertaining to handling of raw materials that are used in API production and creating specifications for finished API release. As an example, FDA inspectors came across at least one executed batch record that did not have an associated lot number. This can make it hard to trace, as you know. But this occurred because Asada does not have written procedure for assigning lot numbers (HERE IS THE FDA LETTER).

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There is more, though. Asada failed to have a program to monitor API stability characteristics or set an expiry or retest date for APIs based on the evaluation of data derived from stability studies. Finally, Asada did not perform process validation for what the FDA described as critical manufacturing parameters of all manufactured API products.

In short, Asada overlooked many of the basic steps needed for API production. As a result, the FDA recently issued an import alert on a variety of Asada products.

Source

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