Security Planning for the Pharmaceutical Industry

Far-flung enterprises and stringent regulations create a challenge for security executives


For the larger and more populated facilities, a messenger drop-off center or mail room isolated on the ground level should be considered to eliminate unescorted messengers and outside delivery personnel from roaming the building. Packages and envelopes can be screened before being delivered by internal personnel. Packages destined for the research lab may have to go through an entire validation process rather than subjecting them to X-ray screening. Screening through an X-ray system may destroy biological matter or affect its efficacy and usability. After the anthrax scare which started in 2001, a number of pharmaceutical corporations have moved their mail room operations and messenger centers to off-site facilities to confine any potential contamination to a smaller controlled environment.

Laboratories and animal research facilities require stringent access control not only from a security perspective but also to ensure that these areas are maintained within a controlled environment. The revised 21 Code of Federal Regulations (CFR) Part 11 stipulated by the Food and Drug Administration (FDA) requires pharmaceutical manufacturers to provide greater production transparency through audit trails and access control functions. Some facilities have taken the next step and are using biometrics, such as fingerprint identification, either in smart cards featuring embedded biometrics or in devices that record fingerprints and the use of retinal scan systems for ultra-clean processing environments, where operators must wear gloves.

 

Protecting the Supply Chain

After prescription medications leave the manufacturing facility, they typically pass through a number of wholesale and retail drug distributors before ultimately reaching the local pharmacy or hospital. While shipping and handling of controlled substances is conducted under secure conditions, every step along the pharmaceutical supply chain presents an opportunity for tampering or diversion by criminals. Some manufacturers have gone to great lengths to protect the pharmaceutical supply chain by introducing innovative security measures where they tag individual bottles of medication with small electromagnetic chips known as radio frequency identification (RFID) tags, which enable pharmaceutical manufacturers and wholesale distributors to more closely track products as they move throughout the distribution chain.

 

Centralized Command and Control

Whether an organization consists of a few facilities that are locally dispersed or many that span the globe, an integrated enterprise security solution gives corporate security personnel in this environment central control over the entire system, while each local facility maintains independent control of its individual operation. Residing on the corporation’s network, an enterprise solution typically consists of the integration between access control, intrusion monitoring, video and visitor management as well as audio communication systems. It provides corporate security administrators the ability to configure and monitor from a central location.

A number of pharmaceutical companies with national and global presence have implemented Crisis Management Centers which are staffed around the clock to monitor, manage and coordinate responses to incidents that may threaten or have harmed the organization at any of its locations. By reviewing intelligence reports from various sources for daily specifics on natural and man-made disasters, animal rights activities and terrorism, corporate security can dynamically deal with situations as they unfold.

As part of the crisis response tools, the enterprise security solution provides the ability to monitor and record emergency events as they occur via video management and initiate response actions and notification through the access control and communication systems.

 

Fred Miehl is a Certified Protection Professional with the security systems design consulting firm of Aggleton and Associates, Inc. He is a member of ASIS, and a member of the IAHSS; he is also a former board member of the International Association of Professional Security Consultants (IAPSC). Fred has been planning and designing security systems for more than 30 years and can be reached at fred.miehl@aggleton.com