For a lab manager in a regulated environment, the acronym GMP (Good Manufacturing Practice) often brings a sense of dread. The regulations are dense, the stakes are high, and the FDA’s warning letters are public.
But compliance doesn't have to be a labyrinth. In the webinar "GMP Compliance Made Easy: Auditing Suppliers and Vendors / Qualifying Analytical Equipment," Lab Manager breaks down the massive concept of compliance into two manageable pillars: controlling what comes in (vendors) and validating what you use (equipment).
If you are preparing for an audit or just trying to tighten your quality loop, this presentation is your roadmap. Here are the key takeaways.
Pillar 1: Auditing Your Suppliers (The "External" Control)
Many labs make the fatal mistake of assuming that if they buy from a reputable vendor, the compliance box is checked.
- The Reality: The FDA holds you responsible for the materials you use. If your supplier fails, you fail.
- The Strategy: The webinar details how to perform a Quality Audit on your vendors. This isn't just about checking prices; it's about verifying their manufacturing processes, their validations, and their documentation.
- The Takeaway: You will learn how to write "Requirement Specifications" before you buy, ensuring you have a paper trail that proves you did your due diligence.
Pillar 2: Qualifying Your Equipment (The "Internal" Control)
Once the instrument is in your lab, how do you prove it works as intended?
- The Framework:The presentation walks through the "Alphabet Soup" of equipment qualification that every GMP lab must master:
- IQ (Installation Qualification): Did we install it correctly?
- OQ (Operational Qualification): Does it operate according to specs?
- PQ (Performance Qualification): Does it work consistently for our specific application?
- The Data Piece: A major highlight of the session is the focus on 21 CFR Part 11—the regulation governing electronic records. You will learn how to ensure your shiny new instrument isn't a digital liability.
Why You Should Watch
Regulatory guidelines are written in legalise; this webinar translates them into English. Whether you are setting up a new calibration program or preparing for an FDA inspection, this session provides the practical checklists you need to prove your lab is in control.
Watch the full webinar below to demystify your compliance strategy:
Key Takeaway
As you watch, pay attention to the section on "Risk-Based Auditing." You don't have the resources to audit every paperclip supplier. The webinar explains how to categorize vendors by risk level so you can focus your auditing energy where it protects your data the most.
Presenter: Joy McElroy
Joy McElroy offers 14 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries in quality control and clinical and GMP auditing as well as validation engineering. Joy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, and GMP and GLP training. She has written and executed equipment qualification and validation protocols for numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.
