Qualitox Podcast: Essentials of Qualification Protocols
Hosted by: Ian Google
Guest: Nathan Roman
Sponsor: Yupri - Leading Temperature Compliance Service
Introduction
Nathan Roman: Director of Validation at Genesis AAC
Focus: Thermal validation, temperature mapping studies, equipment qualifications
What is a Qualification Protocol?
A written plan describing the process to be qualified
Includes the specific items and activities for proper tests on equipment or systems
Ensures equipment meets documented requirements and performs as expected
Preparing Qualification Protocols
Understand the Project and its Requirements
Use Templates: IQ/OQ/PQ protocols for consistency
Prerequisite Form: Helps in understanding the project, cutting down costs, and delivering thorough protocols
Information needed: Contact info, point of contact, roles for protocol review and approval, equipment details, calibration info, previous validation status, supporting documentation
Common Problems in Protocols
Unfulfilled Prerequisites: Missing info can delay review and approval
Good Documentation Practices (GDPs): Training needed for proper documentation
Initial and date verification, clear comments in protocols
Attachments: Proper labeling and logging of spec sheets, manuals, drawings, etc.
Changes with New Technologies
Paperless Validation: Increasing recognition and acceptance
Plug and Play Solutions: Vendor testing and certification at the facility
Mixed acceptance in the industry; in-house testing still preferred for quality assurance
Protocol Issues and Funny Stories
Missteps: Equipment not powering on due to not being plugged in
Crazy Finds: Approved document ripped in half, taped together, and executed
Training Resources
Lack of Comprehensive Resources: Existing training platforms offer some info but more is needed
Training Gap: Need for free courses on writing, executing, and understanding protocols
Ongoing Efforts: Working on providing detailed information and setting up training courses
Final Notes
Importance of Validation and Qualification: Ensures quality and compliance in the Life Sciences industry
Efficiency in Validation: Leads to quality assurance and ultimately saves lives
Acknowledgment: The work being done in the field is valuable and significant
Conclusion
Next Topic: Temperature mapping
Thanks: Appreciation to Nathan for the insightful session
Sponsor Reminder
Yupri’s wireless temperature Data Logger: Real-time temperature reports and alerts for compliance