Pharmaceutical Recalls: A Risk and Compliance Roadmap for Manufacturers

4 min read

The three aspects a manufacturer must swiftly address in the instance of a pharmaceutical recall.

All manufacturers and distributors wish to avoid having to recall a product. Through governance, risk and compliance tools, and processes they aim to safeguard product quality and standards. This takes not only attention to detail and precision within the company’s own business operations, but also with those of its suppliers and third parties, as well as effective monitoring and assessments across the whole supply chain.

However, plans do have to be made around handling a product recall should one need to happen. With increasing regulatory demands and complex international supply chains, effectively managing a pharmaceutical recall takes a coordination effort of many responsibilities.

Among the many aspects a manufacturer has to get right is the identification of key decision makers, a clear understanding of roles and responsibilities, and a robust communications strategy. The damage to company brand and reputation can be severe for those that get it wrong.

1. Decision Makers

The Food and Drug Administration (FDA) is responsible for protecting human health by ensuring the safety of pharmaceutical products. They can request or order a product recall when it becomes aware of a problem; but recalls are also initiated by the manufacturers themselves.

The FDA takes an advisory as well as reinforcement role through guidance on recall processes and action needed through the stages. Senior management, quality assurance, regulatory liaison, and communicators will be central to a manufacturer’s recall process.

An effective product recall hinges on the company’s level of preparation. Identifying, training, and updating the core team that will be involved in the event of a recall is essential, as is clearly establishing decision-making authority at each stage of the process. Plans should be regularly tested to identify any knowledge or process gaps that must be filled.

Throughout the decision-making and recall process itself, manufacturers need to keep the FDA informed, as well as work closely with suppliers, distributors, and other third parties along the supply chain to take effective action. The FDA assigns a classification to the recall—which is essentially determined by the level of danger the quality or safety issue presents—and this impacts a number of factors in the recall process, including urgency and method of distributor/customer notification.

2. Roles and Responsibilities

Any confusion over roles and responsibilities can result in delays, process stages being missed or not executed well, and possible non-compliance. Decision-makers, plan executors, and communicators need a common understanding of their role and responsibilities as well as those of others involved. This extends outside company walls to suppliers, distributors, regulators, and third parties.

The pharmaceutical industry is a global one with many manufacturers supplying multiple markets. Where licenses to sell in particular markets are held by multiple third parties, a lack of clarity over who has what responsibility—and/or any breaks in the chain of communication—can cause significant problems.

To maximize success, manufacturers must cultivate a transparent environment of information access and exchange. This is essential not only to track impacted parties and the root cause of the issue but also to keep all players up to date throughout the recall process. All responsible individuals need to work from the same information, and it needs to be up to date.

This is hard to achieve for many companies still working with systems and applications in silos where shared data has to be interpreted and fed into various tools that support the process.

Plan executors and senior management need visibility into product recall progress as well as the output of root cause analysis and other quality assurance tasks. This is best achieved through real-time executive dashboards and reports with drill-down capability to access relevant statistics, analytics, and trends.

3. Communications Strategy

Poor communication can be found at the root of many poorly-handled business problems. Product recall planning must consider the complete spectrum of communications—intra-company, externally with parties along the supply chain, with customers, and with regulators and officiating bodies.

Time zones, physical distance, language barriers, and cultural differences can all hinder effective communication. These must be managed for timely and effective communication.

Not only does communication need to be effective during the process of a product recall itself, it also needs to ensure the business learns from the situation, feeds information back into the system, and is equipped to take any corrective or mitigating action needed. An integrated solution that tracks and manages information and events across departments can initiate action based on change—for example the requirement for training or actions resulting from an audit.

It is also important when considering the business tools to support effective company communication to think about how people consume information and the clearest and most effective ways of presenting it to achieve the maximum result. The visual presentation of data, for example, can be an effective way of maximizing understanding.

Through planning and the use of technology, manufacturers can streamline and improve the processes and procedures that expedite product recall activities. In this way they aim to limit brand impact, better serve customers, and ultimately drive improved business performance.

Effective governance, risk management, and compliance are essential for good business practice and to try to mitigate issues that may result in the need for a product recall. Despite ensuring effective processes and procedures and compliance with regulatory mandates, issues do still arise and preparation is essential to manage them when they do.

Automated risk management solutions can help support the execution of roles and responsibilities, informed decision making, and effective communication not only when a product recall has had to be decided upon but also minimizing and managing enterprise risk in day-to-day operations.

The original article was published by Pharmaceutical Processing. To read the full blog, click here.



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