Tuesday 16 February 2021

Dissecting the pharmaceutical recall procedure

The types of pharmaceutical products that undergo a recall are as varied as the available products on the market. They include over-the-counter, prescription, and compounded drugs ranging from tablets and capsules, injectable drugs, liquids, lotions and creams, and many more. Similarly, the reason for recalls are equally varied although there is more commonality in terms of the general types of problems that trigger recalls to occur. The leading causes of pharmaceutical recalls are sterility, the presence of particulate/foreign matter, and failed specification testing, according to figures from the U.S. Office of Pharmaceutical Quality.

Every recall is different, so the financial impact varies greatly. It’s based on a number of factors, including the number of units affected and the global reach of the recall. There are also indirect costs that need to be factored in. For example, if pharmaceutical companies don’t work with partners to execute the recall, their internal staff must step in at the expense of their usual duties.

To address recalls, all pharmaceutical companies should periodically review and update their preventive controls,and review their recall procedures. This review process can help prevent certain recalls, such as mislabeling errors. However, it remains that completely eliminating recalls is near-impossible since some issues, such as instability, are most likely to be discovered post-distribution. Therefore, companies should additionally ensure their recall plans are as robust as possible and hold periodic mock recalls to test for various scenarios and identify any gaps in their procedures.

A new article presents a framework that could be used to construct or to revise a recall procedure for a pharmaceutical, healthcare or medical device manufacturer. The procedure should give guidance on how to write and structure recall notifications to wholesalers, pharmacists and other groups. The procedure should address situations in which there is a need to issue press releases in order to caution the public in the use of a product known to be defective but where a product recall is either not feasible or is not considered necessary. It is important that the recall procedure is periodically tested to show that it is fit for purpose.

See below for details -

Tim Sandle has written a new article for IPSE.

Here is the link: https://pbpw.in/blog/f/dissecting-the-pharmaceutical-recall-procedure

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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