Quality Assurance

Background

In the fast-paced and highly regulated landscape of the medical device industry, the selection of components and suppliers plays a critical role in driving efficiency and ensuring product quality. This intricate process involves the seamless exchange of knowledge, processes, and expertise across research, development, and manufacturing phases, culminating in the successful commercialization of medical solutions that address evolving healthcare needs.

At ECI, we understand the paramount importance of meeting regulatory standards, particularly those outlined in 21 CFR 210/211, while also fostering innovation and global collaboration. Our expertise lies in orchestrating modular quality assurance teams that integrate core experts in materials/components properties, incoming and packaging processes, regulatory compliance, and logistical considerations such as yield calculation, expiration date determination, stability testing, special testing, and distribution.

What sets us apart is our ability to assemble multidisciplinary teams and optimize resources to manage parallel projects with efficiency. We recognize the strategic imperative of delivering combination products that not only meet regulatory requirements but also exceed customer expectations in terms of quality and performance. By leveraging our collaborative approach and commitment to excellence, we empower organizations to navigate the complexities of the medical device industry and drive impactful innovations that shape the future of healthcare delivery.

Based on the above, ECI was engaged by a medical device manufacturer to assess and execute activities/actions required for the client to achieve an acceptable level of compliance with FDA combination product regulations (21 CFR 210/211) and internal Quality Management System (QMS) requirements. As part of the actions, components, and suppliers were evaluated under a gap analysis in order to understand the regulation compliance level, identify non-compliance areas, and Quality Management System improvements related to component-drug products/supplier management. Such analysis consisted of evaluating raw material specifications and controls under the listed approach:

• 21 CFR Part 211.84: Pharmaceuticals: Testing and Approval or Rejection of Components, Drug Product Containers and Closures.
• 21 CFR Part 211.103: Pharmaceuticals: Calculation of Yield.
• 21 CFR Part 211.132: Pharmaceuticals: Tamper-Evident Packaging Requirements for OTC Human Drug Products (Not Applicable because it is not an "Over the Counter" product).
• 21 CFR Part 211.137 Pharmaceuticals: Expiration Dating.
• 21 CFR Part 211.165 Pharmaceuticals: Testing and Release for Distribution.
• 21 CFR Part 211.166 Pharmaceuticals: Stability Testing.
• 21 CFR Part 211.167 Pharmaceuticals: Special Testing Requirements.
• 21 CFR Part 211.170 Pharmaceuticals: Reserve Samples.

Approach and Solution

With a deep focus on QMS and regulatory areas, particularly through an engineering approach, ECI brings a wealth of expertise to the table. Known for its innovative solutions and strategic methodologies, ECI has a proven track record of assisting organizations in achieving regulatory compliance, upholding quality standards, and optimizing operational efficiency.

The heparin re-packaging 6S effort emerged as a direct result of a comprehensive gap assessment executed by ECI. Leveraging its extensive experience and engineering-focused approach, ECI conducted a meticulous evaluation of the re-packaging process for sodium heparin. This assessment revealed critical gaps and inefficiencies, prompting the need for targeted interventions to enhance regulatory compliance and streamline operations. Then, the following approaches were driven to unify the execution of heparin 6S correction requirements.

Strategic Assessment

• Conducted a meticulous evaluation of the re-packaging process, considering regulatory requirements, quality standards, and operational workflows.
• Identified areas of improvement through comprehensive gap analysis and strategic assessment methodologies.
• Informed solution development with data-driven insights and industry best practices.

Customized Solutions

• Designed tailored solutions to address specific challenges and optimize the re-packaging process.
• Integrated innovative technologies and methodologies to streamline operations and enhance efficiency.
• Ensured alignment with organizational goals and objectives to maximize impact and sustainability.

Implementation Support

• Provided hands-on support throughout the implementation phase, from project planning to execution.
• Collaborated closely with stakeholders to facilitate seamless integration of solutions into existing workflows.
• Offered expertise and guidance to overcome implementation barriers and ensure successful deployment.

Training and Education

• Developed comprehensive training programs to empower personnel with essential knowledge and skills.
• Delivered customized training modules tailored to address identified areas of improvement.
• Promoted a culture of compliance and continuous learning to sustain long-term success.

Ongoing Support and Monitoring

• Implemented robust monitoring mechanisms to track progress and measure the effectiveness of implemented solutions.
• Conducted regular assessments to identify emerging challenges and opportunities for further optimization.
• Provided ongoing support to address evolving needs and maintain compliance with changing regulatory requirements.

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Comprehensive Action

Under the guidance of ECI, a comprehensive action plan was developed and implemented to address the identified gaps and enhance the re-packaging process for sodium heparin. This initiative involved a strategic approach aimed at improving regulatory compliance, quality management, and operational efficiency. Key elements of the comprehensive action plan included:

Gap Analysis and Assessment: ECI conducted a thorough gap analysis focusing on the component specification and suppliers related to drug products. Regulatory and quality system aspects were meticulously assessed to identify areas requiring improvement.

Lean 6S Implementation: Recognizing the need for improvement in the re-packaging process, ECI spearheaded the implementation of a lean 6S effort. This initiative aimed to streamline operations, reduce waste, and enhance overall efficiency in the incoming and manufacturing areas.

Procedure Development: Collaborating closely with stakeholders, ECI developed a comprehensive procedure to meet regulatory and QMS requirements. This procedure incorporated the six key aspects of 6S methodology: sort, set in order, shine, sustain, safety, and standardization.

Integration of Best Practices: ECI emphasized the adoption of best practices, including good laboratory and manufacturing practices, validated weighing processes, safety protocols, and data integrity requirements. These practices were integrated into the procedure to ensure adherence to quality standards and product integrity.

Continuous Improvement: ECI emphasized the importance of continuous improvement by implementing mechanisms for ongoing monitoring, review, and optimization of procedures. Regular assessments were conducted to identify areas for further enhancement and refinement.

The comprehensive action proposed by ECI not only addressed immediate concerns but also laid the foundation for sustained regulatory compliance, operational excellence, and product quality. By leveraging their expertise and strategic approach, ECI facilitated significant improvements in the re-packaging process, ultimately enhancing the overall performance and reputation of the organization.

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Results

Our solutions optimize resource utilization, enhancing efficiency. Through the implementation of lean 6S effort, we developed a new re-packaging process for sodium heparin. Our comprehensive approach ensures consistent standardized work practices for unparalleled quality and efficiency. Tailored expert knowledge addresses specific client needs, ensuring swift problem-solving. Meticulous development and implementation of procedures guarantee compliance with regulatory and QMS requirements.

Clear guidelines enhance operational clarity, covering waste disposition, cleaning activities, labeling, and traceability. Our commitment to knowledge transfer fosters a fast learning curve among team members. Integration of the 6S methodology ensures adherence to the highest quality standards. Seamless collaboration with clients' teams bolsters project success. Emphasis on safety practices and data integrity enhances overall reliability.

In conclusion, our approach efficiently manages project overlaps, providing expert knowledge transfer and retention.