Incorporating Security Into Controlled Substance/Biotech Facility Design
For most organizations, security is primarily focused on protecting one or more facilities and all people and data from physical and cyber intrusions. However, the best practices associated with security systems must be “leveled-up” when designing facilities to manufacture controlled substances like drugs or conduct biological research—whether constructing a building from the ground up or retrofitting an existing structure.
In particular, security will play a critical role in a facility’s ability to adhere to Good Manufacturing Practice (GMP), a system that ensures products like food, cosmetics and pharmaceuticals as well as many types of R&D work are consistently produced and controlled according to set quality standards. GMP examines and covers all aspects of the manufacturing process to guard against risks that can be catastrophic, such as cross-contamination, adulteration, and mislabeling.
Implementing GMP can help cut down on losses and waste, protecting both manufacturers and consumers. When thinking about security as an element of GMP, it’s important to answer these four questions during the design process:
- Who has access and when?
- What is the critical relationship between doors and airflow?
- How are investigations conducted to provide transparent oversight for governing bodies?
- How is the product protected not only from environment concerns, but sabotage or theft as well?
Here is some guidance that might be helpful.
The Issue of Access
Issuing cards to employees and using a card reader is certainly an appropriate way to control who comes into a facility, but to adhere to GMP it’s critical to be more granular. For instance, it may be necessary to limit access to a holding area where products produced during the day are stored overnight before being shipped out the next morning.
In addition to taking into account specific situations unique to the facility, it’s important to recognize and account for an organization’s culture when designing security within GMP space. How do different platforms communicate with each other? Why is that important? How does the organization manage incidents? And then there are these three important questions to answer:
- Should you allow access 24/7 or only during shift hours, and why one versus another?
- How do supervisors communicate and interact with staff as it relates to physical access?
- What role does security play in daily GMP operations, i.e., shutdowns, arming/disarming intrusion zones, incident management?
The Importance of Interlocking
While interlocks offer first-class physical protection, for GMP purposes they are also used to maintain airflow; an interlock is defined as a series of doors that open intelligently if one door is open, all associated doors are shunted (or locked) until all doors are normalized (or closed).
Interlocking is very important to separate air space and product. Depending on a facility’s requirements, it may be a typical steel single or double door, a roll-up door, or a sliding door. By allowing the access control system to take ownership of this logic, the operational process helps ensure required oversight is met and provides insightful data for investigations.
The Matter of Compliance
GMP spaces typically manage regulated products or biologicals (DNA) that have compliance requirements to ensure transparent practices, thus they have unique design requirements that will facilitate investigations by governing bodies. Detailed monitoring of those spaces delivers the appropriate oversight and provides value to the organization by accelerating the investigation process, which may include:
- Documenting who accessed what space at what time
- Documenting who enabled/disabled an intrusion area
- Identifying if someone is inadvertently trapped and requires emergency egress by overriding locked doors
The Question of Cameras
While GMP does not require the use of cameras, we consider using them to be a best practice and recommend adequate camera coverage to capture the entire product pipeline, which may include:
- Product processing (bottling and palatalizing)
- Shipping and receiving
- Short-term storage
- Long-term storage
Camera coverage has proven to be a very effective tool to mitigate theft and sabotage, and it is a critical asset for the investigation process.
The Takeaway
For organizations that need to protect themselves against problems like cross-contamination over and above the typical security concerns associated with any business, focusing on leveled-up security as an integral part of the design process will ensure compliance with GMP standards. Incorporating best practices such as those we have detailed here is the best way to protect products, consumers, and the organization itself.
About Atriade
Atriade is a trusted security consulting firm with decades of experience delivering tailored security solutions. We specialize in security system design for access control, perimeter protection, video surveillance, visitor management, and other advanced physical security technologies.
Our expertise also extends beyond system design to include security master planning, program development, risk assessments, professional services, and end-to-end project management.
For more than 20 years, we have partnered with Fortune 50 companies, Ivy League universities, and leading technology firms in Silicon Valley to help them navigate complex security challenges with a strategic, forward-thinking approach.
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Frequently Asked Questions
How should physical access be designed in a biotech facility to support GMP requirements?
Physical access should go beyond issuing employee cards and reading credentials at entry points. Access needs to be granular enough to limit who can enter specific spaces, such as holding areas where products are stored before shipment. The design also needs to define whether access is permitted 24/7 or only during shift hours, how supervisors manage access issues, and how security supports shutdowns, arming and disarming, and incident management.
Why are interlocking doors important in GMP facility design for controlled substances research?
Interlocking doors are important because they protect both the facility and the manufacturing environment. In GMP spaces, interlocks help maintain airflow and separate air space from product, reducing conditions that can contribute to contamination risk. When access control owns the interlock logic, the process also creates operational oversight and produces data that supports investigations, which is important in regulated environments.
What security records should a GMP facility maintain to support compliance investigations?
A GMP facility should maintain detailed records showing who accessed each space and when, who enabled or disabled intrusion areas, and whether emergency egress overrides were used to release someone who was trapped. This level of monitoring supports transparent practices and helps governing bodies review events efficiently. It also gives the organization faster access to facts when investigating incidents in regulated spaces.
Are cameras required in GMP spaces for controlled substance or biotech operations?
Cameras are not required by GMP, but they are considered a best practice. Coverage should capture the full product pipeline, including processing, shipping and receiving, and both short-term and long-term storage. This supports theft and sabotage mitigation while strengthening the investigation process. In facilities handling regulated products or biological materials, camera footage can provide critical visibility when determining what happened and where controls may have failed.
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