A Holistic Approach to Package Safety

Lorena L. Williams

Lorena L. Williams, Life Science  Risk Management Specialist, Chubb Commercial Insurance

In the wake of recent drug counterfeiting and tampering incidents, package security is becoming a new area of product liability litigation. With the potential for lawsuits looming, manufacturers should be able to prove that they took every step to protect their products from tampering. 

The spotlight on counterfeiting brings renewed attention to the risks related to product packaging and the most effective ways to minimize these exposures. Counterfeiters copy labels and packages or reuse packages that are not tamper-resistant for fake or diverted products. Furthermore, improperly sealed packages can compromise product integrity by introducing biological hazards. 

Current safety and quality assurance systems focus on finding defects through spot checks and end-product testing. However, alone they cannot ensure safety and manage liability risks. In today�s business environment, medical product manufacturers could benefit from an integrated, enterprisewide risk management program that incorporates Hazard Analysis and Critical Control Points (HACCP). This is a preventive system for identifying and controlling hazards throughout the life cycle of a product to ensure the safety and quality of drugs and medical devices.

Although FDA does not require medical companies to use HACCP, manufacturers would be wise to think beyond regulatory compliance to protect the bottom line. While a holistic risk management program requires an investment, in the long run it can save the expense and reputation damage associated with a potential recall or product liability lawsuit.

Principles of HACCP

HACCP is an ongoing process that consists of seven fundamental steps. 

Conducting a hazard analysis. The hazard analysis looks at every area that could result in potential harm to patient health and safety. These could include package failures that compromise sterility or packages that lack adequate protection against tampering. The analysis should look at each part of the design and manufacturing process to identify potential product safety hazards and preventive measures to control them. 

Determining critical control points. Critical control points are those steps in the process at which a potential hazard can be prevented, reduced, or eliminated. It is important to focus on those that are considered critical and for which preventive measures can eliminate or reduce the hazard to an acceptable level. For example, the point at which a sterile package is sealed is a critical control point.

Establishing critical limits for each control point. These are parameters used to ensure that a control variable in an operation or activity is working properly or that the product meets a safety specification. For example, critical limits for package seals would be established for temperatures and other factors required to produce seals with adequate strength and integrity.

Establishing procedures to monitor each critical control point. Continuous or frequent monitoring of critical control points ensures that preventive measures are working and that critical limits are not breached. Real-time results provide the best chance of detecting and correcting problems quickly.

Establishing corrective actions. Corrective actions must be defined in advance and taken when monitoring shows that a critical limit has been compromised. This may involve removing potentially defective materials from production and getting the control point back within the critical limit or preestablished safety parameter.

Establishing verification principles. These procedures, in addition to monitoring, verify that the HACCP system is working correctly. This can involve statistically valid sampling of the finished packaging and often takes the form of an audit.
Establishing recordkeeping and documentation procedures. This should include records of hazards and their control methods, monitoring records for critical control points, actions taken to correct potential problems, and documentation of verification procedures.

A Holistic View

Risk management approaches like HACCP are suitable for the medical device and pharmaceutical industry if they can be adapted to encompass the entire product life cycle.

Bayer Biological Products (BP; Research Triange Park, NC) used a holistic risk management approach to protect products from tampering. A tampering incident in March 2002 revealed that the protective measures in the initial packaging of Gamimune N. 10%, Bayer BP�s immune globulin therapy for patients with compromised immune systems, were not effective. Users didn�t seem to notice that the seals had been tampered with. At first, Bayer BP responded with enhanced tamper-resistant packaging to help healthcare professionals and patients detect if a Bayer product had been compromised.
Eventually, the new packaging became just one piece in an extensive antitampering initiative that changed the company�s manufacturing, distribution, and outreach programs for patients and healthcare professionals.

Beyond Compliance

Companies must remain vigilant at all times and establish measures that minimize loss exposures and control product liability throughout the product�s life cycle. Regulatory compliance and quality control programs do not properly identify and control risks related to product liability litigation. While using HACCP cannot guarantee safety, it can help companies avoid the pitfalls encountered in many risk programs that concentrate on regulatory compliance. Unlike the quality control measures called for in FDA�s quality system regulation, which focus on the design process, HACCP creates a common thread linking stakeholders throughout the life cycle of a product. It helps to ensure that product hazards and controls are given proper attention and are communicated at every phase.

Lorena L. Williams is a life science risk management specialist for Chubb Commercial Insurance, a business unit of the Chubb Group of Insurance Companies. She can be contacted at 908/572-4719 or llwilliams@chubb.com.