In 2017, the Canadian pharmaceutical market exported $8.9 billion in goods abroad, hence there is no doubt that there pharmaceutical labs possess costly assets and valuable products that must be secured. But not only is security a must in terms of protecting your assets from robbery, pilfering, sabotage or misappropriation, but it’s also a compliance requirement.
Those entities that are legally managing controlled substances – e.g. pharmacies and pharma labs – must follow the Controlled Drugs and Substances Act (CDSA). The federal government enforces the CDSA’s security aspects through Health Canada’s Directive on Physical Security Requirements for Controlled Substances (Directive).
Health Canada requires “all licensed dealers of controlled substances, manufacturing or distributing controlled substances as well as research scientists and analysis laboratories” to adhere to the Directive.
Failing to comply with the Directive can result in a number of consequences, not least losing the necessary licensing to manage controlled substances (i.e. a critical element to any pharma or biotechnology lab).
What is the Controlled Drugs and Substances Act?
First instituted in 1996, the Controlled Drugs and Substances Act (CDSA) is federal-level legislation that identifies substances (e.g. certain chemicals) that are to be restricted and controlled in terms of who may access them (and why).
The CDSA also outlines how law-enforcement agencies are to enforce these restrictions, especially in response to criminal activity. Likewise, the CDSA stipulates how companies authorized to possess controlled substances, such as pharma labs, must manage them.
Directive on Physical Security Requirements for Controlled Substances
Originally introduced in 1999, the Directive on Physical Security Requirements for Controlled Substances (Directive) should be of central interest to pharma labs and biotech companies.
Enforced by Health Canada, the Directive mandates a series of specific security requirements for pharma labs, biotech companies and pharmacies/licensed dealers to follow in order to attain and retain their legal authorization to possess controlled substances.
From the design of the security system to how it is implemented, Health Canada’s mandates a full range of issues, including the minimum technology systems you need to comply with the CDSA. To ensure compliance with the CDSA and Directive, Health Canada has tasked its Office of Controlled Substances (OCS) to inspect licensed labs and dealers alike.
Is the CDSA Relevant to Your Lab?
Yes! The CDSA and Directive are relevant to your pharmaceutical lab, which is why it’s critical to maintain sufficiently strong security measures at your facility.
In fact, not only is security a necessity in terms of compliance, but it’s critical from a business perspective as well. A security breach could result in damages to your expensive assets and, potentially, hamper your ability to operate in the pharmaceutical industry.
Security is Essential for Compliance, Safety, Cost and Reputation
Not abiding by federal regulations will prevent you from continuing your operations. However, should a lapse in your security measures cause (or at least be linked) to a breach, then your pharmaceutical lab will be exposed to the following risks.
Health & Safety
To the government, ensuring public health and safety is a critical concern. In terms of controlled substances, the government’s concerns range from how those substances can support criminal activity and/or present a public health risk through bacterial or viral contamination.
Being linked to such issues can result in government penalties and investigations, which can interfere or increase the cost of your operations. The best way to avoid it is to prevent security breaches from occurring in the first place.
Security breaches can also result in theft of property – including controlled substances – from your pharmaceutical lab as well as damage to your facility. These costly losses will take away from your bottom-line. Likewise, rebuilding your security system to regulations will also add to your costs atop of recovering from damages, theft and possibly government penalties.
Finally, a pharmaceutical lab that cannot protect its critical assets – including its research and intellectual properties (IP) – may not be trusted in the industry. This could affect your ability to attract investors, secure trusted buyers and suppliers and attract high-calibre talent.
Security Essentials for Pharmaceutical Labs
Health Canada’s Directive mandates the following technologies as essential sub-systems for securing your pharmaceutical lab.
In the Directive, Health Canada is pushing the industry to “establish realistic minimum security standards … which are flexible enough to [account for] advances in technology, changes in the drug scene, local problems, construction materials and construction expertise.”
In other words, while these solutions are extensive, Health Canada has recommended them on the basis of them being scalable and future-proof.
24/7 visual monitoring is essential. You can implement this solution via a closed circuit television (CCTV) suite that can capture high-quality footage and store it for retrieval. If an incident occurs, then law-enforcement agencies will demand CCTV footage to support investigations.
Quality is vital. Be it technical malfunctions, poor video quality or loss of functionality (e.g. due to a loss of power), you cannot afford lapses in your CCTV system. Not only is CCTV required as a compliance measure, but it genuinely improves security at your facility.
Visual monitoring can be a deterrent to internal and external breaches alike. Internally, CCTV is a means to deter staff from engaging in pilferage or internal theft. By having CCTV in each area where controlled substances are stored, you could lower the incentive for wrongful acts.
Likewise, a pervasive CCTV network is a must, even outside of the areas storing your controlled substances. For example, loading and receiving areas involve a lot of external movement and in many cases, people who you have not vetted.
Biometric authentication, swiping cards and key codes are among the tried-and-tested ways of adding restrictions to and within your pharmaceutical lab. Be it shielding controlled substances, research, sensitive equipment or your inventory, access control measures are a must.
Not only do access control measures restrict access to sensitive areas, but you can tie assets (e.g. swiping cards) to specific employees, thus building a chain-of-accountability to which you can refer to in case of an incident. Likewise, modern access control systems let you delete the access given to ex-employees, thus reducing risk (from disgruntled staff).
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Intruder Detection & Alerting Law Enforcement
In addition to restricting access and placing your facility under constant surveillance, you must invest in physically protecting your facility. This can start with fencing the outer-perimeter area, but it must also include a proper intruder detection and alarm-monitoring system. In case of an intrusion, this system will trigger an alert to law-enforcement, who will respond to the situation.
If you maintain distributed facilities, such as development laboratories to production sites, then you should consider asset monitoring as well. RFID (radio-frequency identification) chips enable you to monitor – in real-time – the location of controlled substances in-transit.
Start with Proper System Design
It’s clear that integrating a security system – one incorporating visual monitoring, access control, intruder detection and asset monitoring – is a requirement, not just from a compliance angle, but from the perspective of prudent business sense as well.
However, a strong security system is more than simply a collection of systems such as CCTV or swiping cards. Rather, the security system must be designed to address the exact risks faced by your pharmaceutical lab. These risks are based on your lab’s location, the type of substances it works with and stores, and many other factors that are not readily noticed.
Missing any of these factors could leave vulnerabilities in your lab’s security systems and, as a result, place you at a higher risk of a breach and non-compliance penalties.
To solve this ahead of time, it’s best practice to get a professional security company to lead the design and implementation process of your lab’s security system. In fact, Health Canada itself requires that you undertake a proper scoping and risk analysis project prior to selecting and/or installing your systems, so as to ensure all potential threats are addressed from the start.
In addition to properly identifying and addressing your lab’s security risks, a professional firm will also leverage its strong industry partnerships to secure top-quality hardware. This will guarantee that your systems are compliant (for example, you would have the ability to extract CCTV footage of a high-enough quality for law-enforcement investigations) and functional.
At Logixx Security we bring over 47 years of experience planning, designing and implementing security systems for clients in a range of complex industries, including pharmaceuticals. We also have partnerships with Honeywell, S2 Security, Verex Technologies and others for access to today’s leading technology solutions for a diverse array of security requirements.
Contact us today to get started on planning, designing and implementing your lab’s security system in alignment with all government regulations and your business requirements.