by Chris Wubbolt
QACV Consulting CEO I Principal Consultant
During a recent audit, a thoughtful question was raised by one of our consultants regarding the classification of an observation:
Observation: Tubes for clinical pathology (Hematology, Coagulation, and Chemistry)
were stored in an office rather than in a temperature-controlled environment.
Question: Does this constitute a Major finding that could affect test reliability—or can it be considered Minor if informal controls (e.g., temperature monitoring) are in place?
Key Takeaway:
“It’s not always black and white”
As Chris emphasized, “Findings like this often require supporting information and judgment.
It’s not just about where the tubes were stored—it’s about whether the storage conditions met validated specifications.”
He also shared a broader reflection from a past debrief:
“I once classified a finding related to a non-critical system that hadn’t been validated as Major. A client QA rep argued that any system not validated should be a Critical finding.
I explained that if the system is non-critical, it can’t reasonably rise to that level. Everyone agreed—context and classification nuance are essential.”
Chris Wubbolt Response:
“It Depends—Follow the Manufacturer’s Requirements.”
Chris began by pointing out that the critical factor is manufacturer storage specifications:
“Some hospitals or clinics do store tubes outside of controlled areas, but it comes down to what the manufacturer states as acceptable storage conditions. For example, certain hematology tubes might even require refrigeration.”
He referenced two key regulations:
If the tubes were not stored according to manufacturer requirements, this could justify a Major finding. However, context matters.
“If temperature logs show that conditions have stayed within acceptable ranges—even in a non-controlled room—then the observation might be considered Minor,” Chris advised.
Final Thoughts
Before classifying a finding as Major, ensure the following:
AUGUST
2025
Penny Jegede
Sr. Compliance Consultant (GVP, eSystems)
With over 30 years of experience in clinical research, pharmacovigilance, IT compliance, and quality assurance, Penny brings unmatched regulatory expertise and leadership to our team.
Her distinguished career includes roles at Johnson & Johnson, Merck, and Pfizer, with a strong focus on GCP and PV audits, Computer System Validation (CSV), and global Quality System assessments. At QACV Consulting, Penny leads End-to-End (E2E) PV audits, serves as an IT/CSV Subject Matter Expert, and provides advanced regulatory training on topics like AI/ML in GxP systems and CSA principles.
She is widely recognized for her innovative work in risk-based auditing, particularly in pharmacovigilance IT systems. Her expert presentations—such as “Auditing a GxP System with an AI/ML Component” and “E2E Audit Management for IT Suppliers”—reflect her deep understanding of evolving regulatory landscapes.
Penny’s ability to combine strategic oversight with technical detail makes her a trusted advisor to clients and colleagues alike. Her commitment to excellence continues to ensure QACV Consulting delivers high-impact, inspection-ready compliance solutions worldwide.
AUGUST
2025
Melanie Willis
Sr. Compliance Consultant (GCLP, GLP Adviser)
We’re pleased to share positive recognition for an exceptional audit performance from a recent project conducted by QACV Consulting GCLP/GLP Sr. Compliance consultant Melanie Willis.
Following her excellent audit work with our GLP client, they have expressed satisfaction with her professionalism and expertise. As a result of her thorough evaluation, additional on-site follow-up is being scheduled to further assess the scope of the findings.
Our GLP client has requested Melanie’s continued support during the next phase of the project, a clear reflection of the trust and value she brings to our compliance services.
At QACV Consulting, we take pride in delivering meaningful, actionable insights—and we’re proud to see our consultants making a lasting impact.
april
2025
by Angela Haan
GCLP/GLP Adviser | Sr. Compliance Consultant
While there have been no changes to the GLP regulations in recent years, proposed revisions and comments are still under review with no expectation for issuance. However, we may see the FDA issue or revise guidelines to better align with international standards, such as those from the OECD.
Compliance to GCLP is often focused on compliance with international standards and harmonization with other regulatory bodies (such as FDA, EMA, and ICH and industry best practices).
Common compliance issues impacting GLP and GCLP laboratories include emphasis on Data Integrity, effectiveness of the Quality Management System, Technological Integration, Continuous staff training, Adoption of Risk-Based Approaches, Global Harmonization Efforts, and Adaption to Emerging Technologies.
1. Emphasis on Data Integrity:
Regulatory bodies are increasingly prioritizing data integrity.
Laboratories must ensure that all data generated is accurate, reliable, and traceable. This includes stringent documentation practices and audit trails.
2. Effectiveness of Quality Management System:
Inspections of GLP and GCLP laboratories are becoming more thorough, with regulators emphasizing compliance with standards and the effectiveness of Quality Management Systems (QMS).
3. Technological Integration:
There is a growing trend towards integrating digital solutions, such as electronic lab notebooks and automated data management systems, to improve efficiency and ensure compliance with regulatory standards.
4. Continuous Staff Training:
There is a strong emphasis on the ongoing training of laboratory personnel. Regulatory bodies require that staff remain updated on GLP and GCLP practices to ensure that staff are knowledgeable and compliant with current practices.
5. Risk-Based Approaches:
A trend toward risk-based approaches is evident, allowing laboratories to focus resources on critical aspects of studies that significantly impact outcomes.
6. Global Harmonization Efforts:
Regulatory agencies are collaborating to harmonize GLP and GCLP guidelines across regions. This initiative aims to streamline processes for international studies and foster a consistent regulatory environment.
7. Adaptation to Emerging Technologies:
As scientific advancements, particularly in personalized medicine and genomics, emerge, regulatory bodies are updating guidelines to address the implications and challenges these technologies present for GLP and GCLP compliance.
For more information, we recommend checking the FDA’s website for the latest guidance documents and regulatory changes and webinars related to GLP and GCLP.
Summary of
Trends in FDA 483
warning letters for GLP
and GCLP Laboratories
Training and Competency:
Several warning letters pointed out deficiencies in training protocols, emphasizing the need for comprehensive training for staff to ensure compliance with GLP and GCLP standards.
Equipment Calibration and Maintenance:
Many laboratories failed to adhere to proper calibration and maintenance schedules for critical equipment, which could compromise the reliability of results.
Data Integrity Concerns:
Numerous laboratories were cited for issues related to data integrity, including inadequate documentation practices and failure to maintain complete records.
Quality Control Measures:
Non-compliance with quality control procedures was a recurrent theme, with labs being found lacking in proper validation of analytical methods and controls.
Protocol Deviations:
Instances of unreported deviations from approved protocols were noted, raising concerns about adherence to study plans.
FDA WARNING LETTER
A warning letter issued by the FDA to Applied Therapeutics, Inc. on December 3, 2024.
The letter details violations related to the company’s clinical investigations and compliance with FDA regulations.
The FDA raised concerns about the company’s inadequate oversight of clinical trial procedures, failure to properly monitor study sites, and deficiencies in reporting adverse events. The FDA demands that Applied Therapeutics take corrective actions to address these issues, including ensuring compliance with GCP standards and submitting a detailed plan for remediation. Failure to address these violations may result in further enforcement actions.