How to Effectively Manage a Product Recall - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

How to Effectively Manage a Product Recall
The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.


Pharmaceutical Technology
Volume 35, Issue 1

Getting the word out

Once a recall has been deemed necessary, taking the next steps can be critical to the successful implementation of the product recall. It is now time to get the word out. According to the established and documented recall strategy, a recall communication is drafted.

The recall communication is the means by which the details of the recall and the instructions to the recipients are relayed. The depth of the recall determines the level to which this communication involves (i.e., wholesale, retail or consumer). The communication could be by mail, fax, telephone call, or a combination of media to wholesalers and retailers. When the largest population needs to be notified, a public alert may be warranted. This would be disseminated by appearing in newspapers, on websites, over the radio, for example, with the goal of alerting the largest number of people in the quickest amount of time.


Table IV: Basic elements of a written recall communication.
The communication should be concise and instructions detailed and easily understood. The clarity of the communication will dictate the ease and level of compliance that will take place once that communication is received. Table IV lists the main elements of a written recall communication.

The Importance of Keeping Accurate Records

At this point, it is vital that adequate systems be put into place to address each of the different company departments that will be affected by the recall (e.g. receiving, accounting, or customer service). Proper planning at this stage will avoid chaos later when telephone calls and recalled product start pouring in.

When conducting a product recall, as with most parts of the FDA-regulated industry, keeping detailed and accurate records is absolutely critical and the most important facet of the recall. Records such as the consignee list, who was contacted via the recall communication, proof of receipt, status of recalled product, and additional attempts to contact consignees who didn't respond to the initial communication are some examples of the records that must be kept. Keeping accurate inventory-accountability records is equally critical. This includes the product sent back from consignees and being stored in the warehouse for ultimate destruction.


Table V: Recall spreadsheet example.
Each department needs to have accurate records, so that years later, exact details can be retrieved, if needed. One of the best ways to keep track of the recall details is to set up a spreadsheet, so that reference to the information can be easily and quickly accessed. An example of such a spreadsheet is shown in Table V.

Staying focused

As the recall proceeds and the recall communication has been sent, it is virtually a full-time job to manage the recall progress. Keeping the recall on target is very important not only from a compliance standard point (i.e., getting the defective product off the market) but from a company perspective because completing the recall as quickly as possible is also financially prudent and desired.

Two ways that help the recalling company stay focused are by conducting effectiveness checks and status reports. Most times, depending on the type and depth of the recall, FDA will require that effectiveness checks be performed as part of the recall strategy. Effectiveness checks are additional verification that each of the consignees has received the recall communication and is taking the appropriate action as directed by the recalling company. These are performed by mail, phone, email, etc. If these checks show that the means by which the company communicated the recall were not effective (e.g., not reaching the correct people, or not presenting clear instructions on what to do with affected product) the company will need to take additional steps until the recall is shown to be effective.

As part of the recall strategy, status reports to FDA are required at intervals agreed upon by the company and the agency. Status reports summarize the current state of the recall (e.g., how many consignees have responded, how much product has been accounted for, and how much has not been accounted for). This information is not only required by FDA, but is a great way to keep upper management informed and to ensure that the recall process does not get stalled.

While some companies manage product recalls in-house, performing all the detailed steps and preparing all records that are involved, many outsource this task to project-management-focused regulatory compliance consulting firms.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
38%
Breakthrough designations
13%
Protecting the supply chain
38%
Expedited reviews of drug submissions
13%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: Pharmaceutical Technology,
Click here