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When the results of failing tests, product complaints, or compliance deficiencies noted during an inspection determine that
a recall is necessary, time is of the essence and decisive action is critical. Communication lines among many different departments
should be established. Vital information must be gathered, and a recall strategy needs to be generated. All these steps must
be accomplished without delay. The completeness of this information will greatly reduce the effort that will be needed to
execute the recall and ultimately remove the product from the marketplace. A list of the critical information that needs to
be collected is presented in Table III. This information, along with the health-hazard assessment, will be among the first
documents in the recall record and will drive the remaining recall activities.
Once the company has gathered all the necessary information, a recall strategy is established. A recall strategy is essentially
the blueprint of the actions that are to be taken to effectively and efficiently remove the product or products in question
from the marketplace. This strategy must take into account all the factors that are involved with the recall and all the steps
that are necessary to accomplish the desired goal (removing and accounting for all distributed product).
The recall strategy states the suggested depth of the recall. Recall depth is the level in the distribution chain to which
the company will contact in order to retrieve the recalled product. There are three levels: wholesale level, retail level,
and consumer level. The selected level is determined by the severity and probability of the health hazard associated with
the product based upon the conclusions of the health-hazard assessment. Recalls on the wholesale level usually are necessary
when the product poses little to no health risk.
The more serious the risk created by the product, the greater the depth of the recall. An example of a recall that may be
conducted on the wholesale or retail level are a product with a label that had an inaccurate statement such as a warning for
taking more than 8 tablets in 24 hours, when in fact the statement should be 12 tablets in 24 hours. Other examples include
a product that, upon shelf life testing, failed to meet the potency specification prior to the stated expiration date or a
product that failed a sterility test.
A recall on the consumer level is the most serious type of recall, as the product has a chance to cause serious health risks
and even death. In this case, it is critical to remove as much product as possible from the market. An example of a recall
that may be conducted to the consumer level is a product that contains an ingredient that may cause harm if taken in the quantities
listed.
Besides the recall depth, a recall strategy includes the detailed plan for executing the recall, including how to communicate
the recall and how the recalled product is to be handled and disposed.
Contacting FDA
Once the health-hazard assessment has been conducted, the critical-information list has been assembled and the recall strategy
has been organized, the FDA regional office recall coordinator is consulted to discuss the product failure and the company's
proposed course of action.
The product details are submitted to FDA in the form of a recall submission document, which contains all the details that
are necessary for FDA to evaluate the product failure, how that product failure will affect consumer safety, and the adequacy
of the planned course of action. This includes product details, a description of the problem, distribution information, the
health-hazard assessment, and the proposed recall strategy.
Nancy Cafmeyer is a consultant at Advanced Biomedical Consulting (ABC), LLC, with over 28 years industry experience has consulted at numerous pharmaceutical, nutritional supplement, and medical device manufacturers and prior to working for ABC has held both hand-on and management positions at companies such as King Pharmaceutical, Geopharma, and Daniels Pharmaceuticals. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522.
Articles by Nancy Cafmeyer
Jonathan M. Lewis, a principal at Advanced Biomedical Consulting (ABC), LLC, has consulted at over 50 different biopharmaceutical, pharmaceutical, and medical device manufacturers and prior to starting ABC has held both hand-on and management positions at companies such as Cardinal Health, KMI, and PAREXEL International. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522
Articles by Jonathan M. Lewis
Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
21%
To all process for new products only
13%
To select process for new products only
26%
To select processes for both new and legacy products
