Achieving Pharmaceutical Industry Compliance

Pharmaceutical industry manufacturing scene
A Pharmaceutical Industry Compliance Case Study
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We helped Glenmark Pharmaceuticals create a secure environment that meets compliance requirements.

Background: A Leader in Generics

Glenmark Pharmaceuticals, Inc. USA, is the North America division of Glenmark Pharmaceuticals, Ltd. based in India. The company first entered the U.S. market in 2003 and today is one of the leading generic pharmaceutical manufacturing companies in the country. Its pharmaceuticals include those focused on dermatology, hormones and controlled substances.

The Situation: Security and Compliance Challenges

As part of its growing U.S. footprint, Glenmark recently opened a new formulation facility in Monroe, North Carolina that will be working in the cancer drug treatment arena. The new facility is approximately 200,000 square feet.

Operating a formulation facility, whether for branded or generic drug manufacturing, is a complicated endeavor due to the constantly evolving security and regulatory compliance issues that are in place for the pharmaceutical industry. For example, the USP Chapter 797, which provides procedures and requirements for compounding sterile preparations to prevent harm to patients that could result from contamination, is now adding more security-related requirements. Providers must be aware of these procedures and requirements to maintain compliance at their facilities. Security systems today must provide an audit trail that shows a secure environment is being maintained.

Other considerations that companies need to address include:

  • State Board of Pharmacy specifications that can vary from state to state
  • HIPAA requirements
  • Miscellaneous USP and federal guidelines

To be certified as an FDA compliant facility, Glenmark also needed to address the requirement that no air between the main facility and the formulating and packaging areas be interchanged. This brought additional challenges to the design and implementation of the security systems for the facility.

Originally Glenmark had determined that it was going to award the project to another security provider. However, after exhaustive follow-up efforts by Protection 1’s commercial sales representative and open issues with the incumbent, Glenmark’s project manager gave Protection 1 the opportunity to provide a quote for a “design build” for the full security system. In the end, Glenmark awarded Protection 1 the entire job.

The Solution: Integrated Security Technologies

Protection 1 integrated solutions for Glenmark included:

  • A Fire-Lite fire alarm system
  • A large multi-partition Honeywell intrusion solution
  • Avigilon IP video cameras with server storage
  • A cloud-based Brivo access control system

To address the air interchange requirements set forth by the FDA, Protection 1 included a Dortronics door interlocking solution. This solution uses multiple doors entering into the “clean environment.” The design included a timed interlock whereby staff members could only open one door at a time and with each entry, trigger a fan to circulate and clean the air of impurities in each area. This is done in two and three door intervals.

To meet the strict regulatory compliance requirements as it relates to audit trails, the integrated solution also included a Suprema biometric access control component, complete with time and attendance features.

Future phases of the installation will also include working with a third-party gas detection company to provide detection and notification of inert gases in the clean facility. Once installed, Protection 1 will monitor the facility for the presence of these gases and alert the company should the situation arise.

Because the components of the integrated system rely heavily on IP-enabled devices, Protection 1 worked directly with Glenmark’s IT technologies provider to design and install a separate security network so as not to consume the corporate data network bandwidth with the video and access control systems.

Glenmark will also take advantage of Protection 1’s eSuite account management solution. eSuite will allow Glenmark to view and edit data including contact, PIN # and panel code information, open/close schedules, alarm system tests, and site activity.

Supporting Glenmark went beyond just designing, installing and implementing a state-of-the-art security system. Protection 1 also worked with this customer to facilitate communications with the local AHJ. Being a company that primarily worked in Europe and South America, having an advocate at Protection 1 helped assure the project moved forward smoothly.

The Results: A Lasting Partnership

Protection 1 has successfully completed the first phase of the project and is now working to finish the second phase. Glenmark is also in the process of opening two additional facilities which would add another 400,000 square feet to its operations. Because of the successful implementation at the Monroe facility and its due diligence, Protection 1 has been awarded all other aspects of the project as well.

Customer service goes beyond just installing security systems; it includes partnering with the customer and understanding the unique and often complex requirements of operating their particular business. This is just one example of going the extra mile to ensure complete satisfaction made possible only through the efforts of a team of professionals.

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