Clarifying Laboratory Equipment Qualification: Insights and Strategies

Welcome To Our Latest Edition of "Temperature Matters"

In this edition of our newsletter, we step into the essential world of laboratory equipment qualification. With over twenty years of experience in the health and life sciences sector, I want to share the lessons learned and insights gained on this critical topic. We'll talk about the importance of a well-thought-out approach, the common hurdles we all face, and the continuous efforts needed to uphold the highest standards of quality and compliance. This conversation is about sharing knowledge and fostering a community committed to excellence, aiming to make the complexities of equipment qualification more understandable and less daunting for everyone involved.

Whether you're a newcomer to the concept of temperature mapping or seeking to enhance your existing protocols, "Temperature Matters" is your go-to resource for all things related to temperature control in the critical environments of the Health & Life Science sector.

Firstly, a heartfelt thank you to our incredible sponsors, whose support allows us to share this knowledge on LinkedIn at no cost. Your dedication to our community is deeply appreciated.

Today's issue is brought to you by:

Trinity Solutions and Services, is a company with over 40 years of experience in asset management and staffing services. Their asset management services include computerized maintenance and calibration management, administration, data entry, and equipment hierarchy development.

They also specialize in maintenance scheduling, focusing on the development of preventive maintenance plans with detailed tasks to minimize asset downtime.

Reach out to Leslie Matey to Learn More

Lifecycle Labs, a leader in tailored environment monitoring services for the healthcare and life science sectors. With a commitment to scientific excellence, regulatory compliance, and environmental stewardship, we strive to be your trusted partner in ensuring the safety, quality, and sustainability of your operations.

Reach out to Irina Belyakova ?? to Learn More

Laboratory Equipment Qualification: A Pillar of Excellence

At the core of our industry's pursuit of excellence lies the critical process of laboratory equipment qualification. This process is not just a procedural necessity; it's the backbone of our commitment to maintaining the highest standards in research and manufacturing. By ensuring that every piece of equipment performs reliably and complies with regulatory standards, we uphold the integrity of our data and the quality of our products.

The Comprehensive Journey From Foundation to Continuous Commitment

From the foundational understanding of what it means to qualify equipment, to the strategic approach that encompasses every step from Installation Qualification (IQ) through Operational Qualification (OQ) to Performance Qualification (PQ), we've looked into the essence of what makes equipment qualification both necessary and impactful. This journey is not reserved for the complex instruments alone but is equally critical for simpler equipment, emphasizing the importance of mechanical performance and specification adherence across the board.

Overcoming Challenges Through Strategic Solutions

The path to achieving and maintaining equipment qualification is fraught with challenges, from ensuring data integrity to managing calibration accuracy. However, through detailed planning, robust training, and a steadfast commitment to continuous improvement, we can navigate these challenges effectively. These practices not only solve immediate problems but also foster a culture of excellence and innovation within our teams and organizations.

A Commitment to Continuous Quality

Perhaps most importantly, we've recognized that equipment qualification is a continuous journey. Regular maintenance and re-qualification are essential to ensure that our equipment not only meets current standards but is also prepared to adapt to future advancements and regulatory changes. This ongoing commitment is what allows us to confidently produce accurate and safe results, day after day.

Closing Thoughts

As we close, I invite you to reflect on the significance of laboratory equipment qualification in your own work. It's more than just a set of procedures; it's a testament to our dedication to quality, compliance, and safety. Let's continue to share knowledge, embrace challenges as opportunities for growth, and foster a community committed to excellence.

Thank you for joining me on this journey. Together, we're not just meeting standards; we're setting them.

Follow-Up Q&A from a recent Webinar on Laboratory Equipment Qualification

Building on the foundation and insights shared in our exploration of laboratory equipment qualification, we now transition to a valuable dialogue that extends the conversation beyond the written word. Below, you'll find a curated selection of questions and answers from my recent webinar on Laboratory Equipment Qualification, where I discussed practical applications, addressed real-world challenges, and further unpacked the complexities of ensuring equipment compliance and performance in our industry.

A copy of the presentation is here: https://drive.google.com/file/d/1FI6gK1I-X2TlrPv2RJJNidXcPZY8mZZ6/view?usp=drive_link

This Q&A session reflects the collective curiosity and expertise of our community, offering additional perspectives and solutions to enhance our understanding and practices.

Understanding Qualification Across Equipment Types

Question: The qualification process is the same as for computer software and computerized systems. I can imagine it 100% applies to instruments associated with computer output. Is it equally valid for simple equipment without any software?

Answer: While the qualification process for software-heavy equipment is well-documented, it's equally important for simple equipment without software. Without knowing the specifics of the equipment to which you are referring, I can speak in generalities and even basic instruments need to be verified for their mechanical specifications and performance criteria to ensure they're fit for their intended use. Although less complex, the qualification process for such equipment follows the same principles – ensuring equipment consistently produces reliable results according to defined specifications.

Anticipating FDA CSA Guidelines

Question: Do you expect the lab equipment qualification will adopt the FDA CSA guideline once it is final?

Answer: As the FDA's CSA (Computer Software Assurance) guidelines are still in draft form, it's yet to be seen how they will be integrated into lab equipment qualification upon finalization. However, the trend is clear that the FDA is moving towards a risk-based approach, focusing on critical thinking over documentation-heavy processes. It's reasonable to expect that once finalized, these guidelines will influence future qualification processes, fostering a more efficient, risk-based mindset.

Qualification in Early Development Stages

Question: Formal qualification of instruments needed for early development, and or Phase I/Phase II studies?

Answer: Qualification during early development stages and Phase I/II studies is a balance between ensuring data integrity and practical resource allocation. While the full rigor of GLP and GMP might not be required, a tailored qualification based on risk assessment ensures that the equipment can reliably generate the data needed for these early phases.

The Necessity of Micropipette Qualification

Question: Is qualification of micropipette necessary? If yes, kindly brief.

Answer: Yes, micropipettes require calibration and qualification. Given their critical role in precise volume measurements, ensuring their accuracy and precision is non-negotiable. The qualification typically involves verifying that the pipettes can consistently deliver the correct volume within specified limits.

Focus on GLP/GMP Across GxP Areas

Question: Why the focus on GLP/GMP? Does this apply to all GxP, i.e., GCP, GVP, etc.?

Answer: The focus on GLP/GMP stems from their stringent requirements for laboratory and manufacturing processes. However, the principles of qualification apply across all GxP (Good Practice) areas, including GCP (Good Clinical Practice), GVP (Good Vigilance Practice), etc., anywhere where equipment performance directly affects the quality of the output or product.

Distinguishing PQ from Validation

Question: Could you clarify if/what the difference between PQ and validation is?

Answer: Performance Qualification (PQ) is a component of the overall validation process. PQ focuses on proving that the equipment performs as intended in the actual operational environment. In contrast, validation is a broader term encompassing the entire process of ensuring a system consistently produces results meeting pre-determined specifications.

Individual OQ Necessity

Question: Would be interesting to understand: Each piece of equipment needs IQ (installed correctly). But, do you do OQ once per type/model. If not (you have to do full OQ on each separate piece of like equipment from the same manufacturer, model, etc.), that would imply no confidence in consistent manufacturing by the vendor?

Answer: Each piece of equipment indeed requires its own IQ. However, for OQ, while it's efficient to do it once per type/model, performing OQ on each unit ensures individual performance meets specifications, addressing any variability in manufacturing. This doesn't reflect a lack of confidence in the vendor but rather a commitment to thoroughness and quality assurance.

Validation Versus Manufacturer Claims

Question: I am also thinking that the confirmation that an equipment will perform as claimed by manufacture implies validation, what do you think?

Answer: Confirming that equipment performs as claimed by the manufacturer is part of the validation process, which encompasses different qualification stages. Validation serves to independently verify the manufacturer's claims, ensuring equipment is suitable and safe for its intended purpose within the specific operational context of the lab.

FMEA in Risk-Based Approach

Question: Is FMEA tool considering RPN (Risk priority number) for implementing risk-based approach is applicable here?

Answer: Absolutely, Failure Mode and Effects Analysis (FMEA), with its Risk Priority Number (RPN), is a valuable tool for implementing a risk-based qualification approach. It helps prioritize which equipment and what aspects of its operation need more rigorous qualification based on the potential impact of failure modes.

Scheduled Requalification Strategy

Question: Under scheduled requalification, do you recommend full qualification or partial qualification depending on equipment changes or operation?

Answer: Scheduled requalification can be full or partial, depending on what has changed with the equipment or its operation. If there are significant changes that could impact the equipment’s performance, a full requalification might be necessary. For minor changes, a partial or targeted requalification may suffice.

Qualifying Previously Purchased Equipment

Question: Can you Qualify equipment that was previously purchased for the lab?

Answer: Yes, equipment previously purchased can and often should be qualified, especially if it's critical to product quality or if it's being repurposed for a different task. The qualification would ensure that the equipment still meets necessary operational specifications and regulatory standards.

The Role of Checklists in Qualification

Question: Are there checklists?

Answer: Checklists can be a practical tool in the qualification process, providing a structured approach to ensure all necessary steps are taken. They can guide the qualification activities and help in maintaining consistent documentation and compliance.

Formal Qualification in Early R&D and Clinical Studies

Question: How important is it to do formal qualification in early R&D and clinical studies?

Answer: In early research and early clinical trials, like Phase I/II, how strictly we follow formal qualification (like the V-model or Risk-Based) depends on the nature of the study and the potential impact on future clinical applications. While GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) environments typically require rigorous and detailed qualification processes, early R&D environments might adopt a more flexible approach. However, it's important to note that even in early stages, a certain level of equipment qualification is recommended to ensure data integrity and reproducibility. The extent of qualification can be guided by a risk assessment, considering factors like the criticality of the data and its intended use in future applications.

Time and Resources for Qualifying Equipment

Question: How long does it take to fully qualify something like a SpectraMax M5 Plate Reader?

Answer: It depends on a few things, like how complex the SpectraMax M5 Plate Reader is, what we need it to do (that’s the URS), and how experienced the team is. Usually, for a team that knows what they're doing, it might take around 60 to 80 hours over a few weeks. In my previous days of quoting a project I would shoot for 88 hours. This includes everything from figuring out what we need (URS) to the final checks (PQ) and writing the report. It’s important to remember that sometimes things can get complicated, especially during the testing part (OQ), or unexpected issues might come up.

Frequency of Repeating OQ and PQ

Question: How often should we repeat OQ and PQ?

Answer: You've raised a key point about the ongoing qualification process. After the initial Installation, Operational, and Performance Qualification (IOPQ) is completed, any further testing due to changes or repairs is typically termed as Requalification (RQ). RQ might include elements of both OQ and PQ, depending on what triggered the retesting.

The frequency of RQ really depends on several factors. If there’s been a significant repair, upgrade, or change in the lab that affects how the equipment works, an RQ is needed to make sure everything still operates correctly and safely. The extent of this RQ – whether it's more focused on operational aspects (like OQ) or performance outcomes (like PQ) – will depend on the nature of the change or repair. In some cases, an annual RQ might be sufficient for routine checks, but this can vary based on the equipment's use, importance, and how stable it has been over time.

Essentially, we decide on the need and scope of RQ by assessing the risks and potential impacts of any changes, ensuring our equipment continuously meets the required standards and delivers accurate results.

Stay Tuned:

Stay tuned for more insights and reflections in our upcoming editions. As we continue to navigate the complexities and advancements in our field, we'll share experiences, challenges, and successes that connect us all. Your engagement and feedback are not just welcomed; they are essential in shaping our journey together. So, let's keep the conversation going, learning from each other and striving towards excellence in everything we do. Thank you for being a part of this community.

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