Exercising Inspection Readiness: How to Achieve Compliance and Minimize Risk
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June 27, 2024
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A deadly multistate outbreak in the United States last year resulting from the sale of microbially contaminated ophthalmic drug products led the FDA to issue three warning letters to the manufacturers involved.1 Two of these companies were warned about shirking their responsibilities for ensuring GMP (Good Manufacturing Practice) compliance for contractors they used to manufacture their products.2 This is a classic example of GxP non-compliance that directly led to patient harm.
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The Life Sciences industry operates under the watchful eyes of various regulatory bodies, such as the FDA, EMA, TGA, and PMDA. These agencies are tasked with ensuring product quality and patient safety, with the FDA alone conducting an average of 4,322 inspections yearly across biologics, drugs, and medical devices manufacturing facilities in the United States.3 The stakes are high; non-compliance can tarnish a company’s reputation and lead to potentially severe operational and financial repercussions. The FDA has issued 2,849 compliance actions, including warning letters, injunctions, and seizures, since 2009.4
Inspections can be either scheduled or unexpected, highlighting the critical need for constant readiness. Proactive adoption of robust resources allows manufacturers to navigate inspections smoothly, while displaying dedication to quality standards. How can you ensure your organization is inspection-ready?
Navigating the Complexities of Effective Inspection Readiness Programs
Ensuring regulatory compliance is crucial, and businesses must always be ready for audits and inspections. Conducting a detailed gap analysis can reveal areas of non-compliance, and having an inspection readiness strategy can guarantee that all processes, documentation, and procedures are current and in place. However, preparing for this is challenging, as companies must overcome obstacles such as:5
- Developing comprehensive procedures for complaint management, medical device reporting, and corrective and preventive actions, among others,
- Ensuring procedures are not only documented but also adhered to by internal resources as well as third-party vendors,
- Providing adequate training,
- Maintaining rigorous laboratory controls, and
- Upholding stringent documentation practices.
With 97,575 citations issued from the 107,743 inspections by the FDA since 2009, the message is clear: maintaining compliance is non-negotiable.6
Where to Start the Inspection Readiness Journey
Preparing for a regulatory inspection demands a thorough review of quality processes, the right resources and efficient time management. Companies maintaining constant readiness fare better during inspections.
The first step towards inspection readiness includes an understanding of the expectations of regulatory bodies and their inspection methodologies, which might include a deep dive into:
- Quality Management System (“QMS”) – includes quality objectives and quality operating procedures, post-market surveillance processes, training processes, document management, change control processes, and data analytics, etc.
- Contract Management and Outsourcing – includes vendor qualification and selection process, supplier quality control and performance evaluation, supplier audits, supplier and vendor contracts and quality agreements, etc.
Proactively identifying compliance gaps and formulating corrective action plans are crucial steps in demonstrating a company’s commitment to regulatory and quality compliance.
Creating a Culture of Inspection Readiness
Developing a culture of inspection readiness is becoming increasingly important, with regulators focusing on this aspect during their evaluations. A synergistic approach involving operations, manufacturing, and quality functions is essential. Ideally, quality assurance extends beyond a dedicated team and is a responsibility shared by everyone in the organization.
Best practices include:
- Strong Communication Channels: Conducting regular meetings and discussions to facilitate exchange of ideas, struggles, potential gaps, and to align their objectives and share insights as well as having a clear escalation hierarchy to avoid confusion.
- Periodic Internal Audits: Ensuring regular audits are performed, either internally or by hiring external auditors, to identify and address potential compliance gaps and remove inefficiencies as well as mitigate risks.
- Real-time Monitoring and Data Analytics: Leveraging advanced data analytical tools and monitoring systems to proactively identify trends and potential deviations and anomalies, and to implement timely corrective actions and mitigate risk.
- Effective Training Programs: Investing in competency programs, regular training sessions, and refresher courses to ensure that employees understand their roles and responsibilities in maintaining inspection readiness.
By incorporating these best practices, organizations will be able to build inspection readiness into their culture and ensure compliance across the organization.
3 Tips to Ensure Inspection Readiness
Adopting a proactive approach to inspection readiness can help manufacturers identify gaps in their processes, mitigate risks, and ensure compliance. Our methodology emphasizes:
- Discovery and Gap Analysis: Engaging with stakeholders across functions to understand the current state of inspection readiness, identify gaps with facility walk-throughs, QA audits, and mock inspections, provide recommendations, and outline a vision for becoming inspection ready.
- Process Design and Implementation: Collaborating to develop and implement a plan to address identified gaps in the GxP processes and ultimately an inspection readiness program to ensure continuous improvement and compliance.
- Organizational Engagement and Change Management: Facilitating the adoption of new processes and ultimately the inspection readiness program through comprehensive training and change management initiatives, ensuring that improvements become deeply integrated and sustainable.
Manufacturing Site Opportunities for Improvement (“OFIs”) – Premier Manufacturing Company | A Case Study
A premier medical devices parts manufacturer engaged the FTI Consulting Life Sciences practice to evaluate the current state of their recently acquired manufacturing facilities in multiple cities across the United States. To become inspection ready, the client wanted FTI Consulting to identify and provide recommendations on various opportunities for improvement related to their quality processes and quality management system prior to upcoming customer visits.
The client was struggling to adhere to the quality objectives and processes across all recently acquired manufacturing sites. The client was also looking at several audits to be conducted by existing customers prior to winning a potentially huge contract. There was also a disconnect between these sites in terms of processes and procedures.
The FTI Consulting team performed a walk-through of several facilities and identified several compliance issues, and reported on the overall condition of these facilities. In addition, FTI Consulting identified several gaps as well as opportunities for improvement by reviewing the client’s existing quality management system and quality processes. FTI Consulting prepared a remediation plan to address quality issues on the manufacturing floor, implemented 5S principles to improve working conditions, and identified long-term solutions to sustain the implemented corrective actions. Ultimately, the client was able to win a huge contract from an existing customer by successfully completing the inspection of their manufacturing operations.
Footnotes:
1: Joanne S. Eglovitch, “FDA issues more warning letters to firms making contaminated eye drops”, RAPS, (04 March 2024)
2: Ibid.
3: FDA, “FDA Inspections Database”, FDA, (27 March 2024)
4: FDA, “FDA Compliance Actions Database”, FDA, (27 March 2024)
5: Ibid.
6: Ibid.
Published
June 27, 2024