Securing Your Pharmaceutical Lab is a Compliance Requirement

If your pharmaceutical lab is handling controlled substances (such as experimental drugs and virus samples), it must follow Health Canada’s Directive on Physical Security Requirements for Controlled Substances (Directive). 

The Directive affects “all licensed dealers, manufacturing or distributing controlled substances as well as for research scientists and analytical laboratories.”

Thus, every pharmaceutical lab in Canada must adhere to the Directive. Not doing so will put you at risk of incurring costly penalties by regulators, at the minimum. However, when it comes to complying with regulations, especially in terms of security, there are multiple routes.

Selecting the right route depends on a number of factors, such as the size of your facility, where it’s located, your leading threats, and others. You will get a better feel of evaluating how each of these is relevant to your pharmaceutical laboratory by using the guide below. 

Security Best Practices for Pharmaceutical Laboratories

Overall, it’s important to remember that there is no one specific way of securing your lab. In fact, while Health Canada has defined the baseline in terms of essential capabilities (discussed here) it prefers ‘diversity’ in terms of how each lab implements its security.

Why?

Because the knowledge a criminal uses on one company cannot be implemented at another as the latter is using a different security system with different concepts, technology, and vendors. In terms of how you can design a system that adheres to best practices, see below. 

Security Concepts

In order to select the security systems that best align with your needs, you must select the right security concept. Health Canada has defined four — which we’ve outlined below — concepts you should consider, each with its own advantages, obstacles, and drawbacks. 

Observation

The observation concept emphasizes deterrence by placing your valuable assets (e.g., your lab equipment) in a place where it’s “under continual or casual observation.”

For example, lab testing is done in rooms with glass walls or you have a window overlooking the storage area or shipping and receiving area. The idea with observation is to dissuade malicious activity by denying the perpetrator an opportunity to act without anyone noticing. 

Split Targets

In a split target approach, you are storing your assets in multiple secured areas instead of just one secured area. The idea is to make it difficult for the perpetrator to complete their objective by placing what they want in two (or more) equally well-protected areas.

For example, you could have certain drugs, chemicals, or other assets in one side of the lab and other ones at the other end. In case one area is compromised, you could still save the other one — or dissuade the perpetrator entirely by making the difficulty outweigh the benefit.

Combined Targets

This is the opposite of the split target approach. With the combined targets concept, you would place all of your assets in one secure area. Controlling cost is a major driver for this concept. 

Rings of Protection

In this concept, your goal is to establish multiple barriers — or ‘rings’ — around the asset. These rings will serve as obstacles for the perpetrator. 

In addition to making theft or sabotage a much more difficult process, the rings could also be a psychological deterrence by making the difficulty of breaching the system outweigh the benefit of stealing or damaging the asset. 

You could implement this by having multiple layers of locked doors around the asset, and then have the asset itself stored in a vault with its own locks. In addition, you could also have visual monitoring via CCTV and an intrusion detection system to tip you off of attempted tampering. 

Selecting the Right Concept

There is no one-size-fits-all approach. You must select the concept that properly protects your specific assets, and that too within your budget. For example, you might not be able to employ the split target concept if you cannot afford to construct multiple storage areas for your assets.

You can determine the appropriate concept for your needs by conducting a risk analysis:

Conduct a Risk Analysis

The factors below should feed into risk analysis. You must determine the consequence of an event, such as the theft of drugs or research IP, to not only your business but society as well.

In terms of your business, the theft of assets (or damage to them) will add to your costs, but it may also cause you to lose sales. In some cases, your laboratory might also be under scrutiny by regulators, which in turn could leave with compliance fines and/or the loss of credibility. 

Your risk analysis should examine the following:

Threats:

You must determine exactly where your threats will come from (and by whom). Are your drugs or ingredients a prime target for theft by organized crime? Are your R&D and IP assets targets for espionage? Would someone have the incentive to sabotage your testing facilities? 

You will need to consider this because if you anticipate espionage to be an issue, then you will need to invest in your internal security measures, such as access controls. 

On the other hand, if you are concerned about theft via burglary, then you should integrate an intrusion detection system with visual monitoring and access controls.

Illicit Market Value of Substances

Determine the illicit market value of your controlled substances. Health Canada listed estimates on its website. The more valuable your substances are to criminal organizations, the more you will need to invest in your pharmaceutical lab’s security system.

Health/Safety Risks of Substances

Some controlled substances can be a health risk if exposed to the public. This is a major priority for the government and a security breach involving these substances could put your pharmaceutical lab in the spotlight of regulators. Not only could this damage your reputation in the industry, but it may leave you with costly fines and legal problems. 

Location

Some geographic locations are higher risk than others. For example, if your lab is located in an area with a strong drug subculture, then you could be in proximity to organized criminals. This would leave your facility as a high-value target for these criminals. 

The Essentials

While there can be differences in how each pharmaceutical lab designs and employs its security system, there are systems you will need regardless of the concept you employ. 

For example, as noted above, you will need access control systems (e.g., locks on doors) for protecting against both external and internal theft. Likewise, each of the concepts above will employ access control, intrusion detection and visual monitoring. 

The variances are not necessarily in the systems themselves, but in how you implement them. For example, you will need to invest in more of those systems in order to design a split target security system. You would also need multiple access control systems for rings of protection.

Perimeter Security

You must secure the perimeter of your facility. Your objective here should be to restrict access to your facility to only trusted parties, such as employees and suppliers. This can involve setting-up barriers, such as gates, fencing, and/or walls, to limit how people can enter your facility. 

Intrusion Detection

Your perimeter security system should be paired with an intrusion detection system. This system will sound-off an alarm in case someone breaches the perimeter — as well as other areas where you have an intrusion detection system installed — or tries tampering with the system.

In tandem, consider installing a system that alerts law-enforcement as soon as someone sets off your alarm system. This will enable the police to be your first-responders, especially in off-hours, such as weekends, holidays, or overnight.

Visual Monitoring

You need visual monitoring to maintain around-the-clock surveillance of your facility, particularly areas vulnerable to potential breaches, such as the storage room or shipping and receiving.

You can implement visual monitoring through a 24/7 closed-circuit television (CCTV) system. By installing CCTV cameras to every critical area in your facility. Not only will it monitor those areas, but their presence may help deter would-be perpetrators from acting. 

Your CCTV should also be able to record and save footage. In case of a security incident, law -enforcement agencies may request that footage as part of their investigation.

Access Control

In terms of access control, you could employ a combination of systems. For example, you could have security personnel at the entrance of your facility or in the shipping and receiving area.

Inside your facility, you need systems to restrict who has access to your controlled substances and sensitive assets. This can be done by installing doors with locks that only open in response to the right key card, passkey, or biometric signature. 

In case of a potential leak or employee leaving, you should also have a policy in place to quickly change keycodes or revoke access from certain individuals. 

Get a Professional Security Company to Help

We can only cover so much in a blog. In reality, to sufficiently understand the security needs of your pharmaceutical lab, you need security experts on-site to examine your facility and to draw on their experience to suggest the right solutions.

Besides ensuring that you have the right security systems installed, a professional security firm will also be your asset. Some leverage partnerships with the security OEMs, which equips them with proven expertise in integrating different equipment (such as CCTV, alarm monitoring, etc) into a cohesive, fully-functioning security system.

Logixx Security brings well over 47 years of experience supporting pharmaceutical labs and companies with designing, implementing, and maintaining security systems. 

Our efforts have helped some of the pharmaceutical industry’s leading brands guard their costly investments and devote their energies to boosting profit, not recovering from theft and damage.

Let’s talk about how we can bring you up-to-par as well.