questions to ask
Life sciences enforcement is on the rise. Are you ready?
Did you know that two-thirds of drug shortages are caused by manufacturing disruptions related to product or facility quality problems, according to the U.S. Food and Drug Administration (FDA)? As innovation and speed to market become ever-more critical in the life sciences industry, managing your laboratory and production facilities for regulatory compliance—alongside efficiency—is more important than ever. To prevent disruptions and ensure that your research and production operations are aligned with regulatory requirements, it’s important to ask the right questions about how your facilities are managed.
Regulatory expectations are constantly evolving, requiring vigilance to ensure that facilities practices anticipate best practices and trends. Amidst these demands, companies with facilities teams attuned to current priorities for safety, quality and compliance will find the greatest success in maintaining compliance.
To learn whether your facilities compliance practices are ready for today’s challenges, the following are six key questions to ask.
1. Does my company monitor and anticipate regulatory inspection and enforcement trends?
Regulations and enforcement priorities are never static, which is why it’s important for compliance and facilities teams to stay abreast of trends. It’s common for the U.S. FDA and other regulatory authorities to uncover emerging issues or promising new compliance practices that other companies could adopt.
For example, the FDA has been scrutinizing pest control more closely in recent years, leading to more controls and greater enforcement attention. Understanding emerging regulatory trends can help your facilities prepare for inspections and avoid unexpected enforcement actions.
2. Do we share compliance and enforcement intelligence among all of our facilities?
Often, the knowledge required to optimize facilities compliance is siloed in different departments responsible for compliance, facility engineering, manufacturing or quality. As a result, the compliance mindset may not be built into daily facilities management practices. Likewise, compliance or quality teams may not be cognizant of facilities changes that affect compliance.
One solution is to create a central team specifically to focus on systemwide facilities quality and compliance. For example, if FDA inspectors at one facility were to flag a certain pest control approach, a centralized facilities compliance team could share the information systemwide.
The team also could analyze general enforcement actions and uncover compliance and quality best practices that could potentially be adopted at all facilities. Similarly, the team could ensure that a compliance innovation at one site is adopted consistently across all relevant sites.
3. Are my facilities vendors properly vetted for regulatory compliance?
In many companies, a lack of coordination between departments can lead to missteps. For example, it’s not unusual for a facilities management team to secure a vendor for a project, only for the compliance team to discover—after the fact—that the vendor’s team member qualifications do not meet good practice (GxP) standards for the work to be done. A wide range of vendors fall under GxP manufacturing and lab regulations including janitorial/housekeeping services, pest control, calibration, utilities maintenance and numerous others.
GxP standards also require assurance that each vendor’s work is being properly performed and documented. To streamline processes and ensure consistency across your company, your facilities teams should have access to a centralized standard tool or platform for vetting and managing vendors performing work on all of your sites.
4. Is our compliance documentation up to date and does it meet regulatory standards?
As data has become an ever-growing part of compliance, the FDA and other regulatory agencies has continued to update its guidance concerning data integrity and governance alongside its record-keeping requirements for GxP operations. Even something as minor as data stored in the wrong format can be subject to enforcement action, and GxP data is subject to numerous rules concerning backup, security, accuracy, documentation and other aspects of recordkeeping.
Consider your current state: if a regulatory agency were to conduct an audit and request documentation of a particular process in multiple facilities, how much time would be needed to gather the relevant information? Obtaining approval to bring medicines to market naturally requires authenticated records for environmental monitoring, equipment validation and other aspects of research, development and production. Relevant records must be available for an audit.
For companies that have not prioritized compliance documentation, efficiently responding to regulatory inquiries may require validated technology upgrades to optimize and centralize record-keeping processes, while minimizing procedural non-compliance incidents. For example, some leading life sciences companies embed electronic logs to document cleaning actions alongside manufacturing actions, enabling production managers to quickly determine whether an area has been cleaned and a new batch of product can be initiated.
5. Have my facilities operations achieved the International Standards Organization’s (ISO) IS0 9001 and ISO 14001 certifications?
As facility management becomes more complex with accelerated technology disruption, ambitious sustainability goals and regulatory compliance pressures, having key ISO certifications can help ensure high quality, safety and environmental efficiency in your operations.
ISO certifications are not necessarily required for life sciences operations in every country but are essential in some. ISO certifications can help reduce costs and increase customer confidence in the safety and reliability of your products.
The ISO 9001 Quality and 14001 Environmental certifications, in particular, validate an organization’s documented processes and policies, and confirm its ability to enhance customer satisfaction. For instance, ISO 9001 encompasses controls for communications and process changes, and demonstrates an organization’s commitment to quality outcomes and quality of service. ISO 45001 requires a framework for occupational health and safety.
6. How are our facilities teams creating a culture of compliance?
The most successful life sciences facilities teams incorporate the compliance mindset into everyday activities. For example, leading companies invest in processes, such as having global quality and compliance teams, and facilities technologies to ensure consistency across all of their GxP facilities.
In addition, building compliance metrics into your facilities performance measures further enhances a culture of compliance.
The questions above may reveal gaps in your facilities compliance practices, and you may need to try new strategies for closing the gaps. However, the rewards are many—creating confidence in your facilities compliance frees your company to focus on the larger business of bringing invaluable new treatments to patients in need.