By Thomas L. Badstubner
The Compressed Gas Association (CGA) is an American National Standards Institute (ANSI) accredited Standards Development Organization. Through a rigorous consensus process, CGA has developed extremely valuable publications for medical and industrial gas firms.
CGA and GAWDA have a unique and cooperative relationship that allows GAWDA members access to these valuable (and expensive) publications for free. To get these resources for free, GAWDA members subscribe to the CGA Safety Program. The process is easy and is explained in a webinar you can view on GAWDA.org.
Here are the essential publications every GAWDA member who fills medical gases should download from the Compressed Gas Association’s website, CGAnet.com
- CGA M-2, General Guide for the Manufacture of Medical Gases Classified as Drugs – This represents the industry interpretation of Food and Drug Administration (FDA) Guidance as of 2006. FDA inspectors should be comfortable with the principles in this document.
Be sure to also download M-15 and PS-42 for the latest industry interpretations of FDA medical gas regulations.
- CGA M-4, Validation of Medical Cylinder Filling Systems – If you intend to conduct process validation at your facility, be sure to apply the principles in this publication. This defines the FDA’s Hazard Analysis Critical Control Point (HACCP) and Federal Emergency Management Administration (FEMA) risk analyses for cylinder fill plants.
- CGA M-6, Guideline for Analytical Method Validation – The FDA has very specific ideas about an analytical method validation and this publication helps bridge the gap between our industry and FDA guidance.
- CGA M-7, Guideline for Qualifying Suppliers Used by Medical Gas Manufacturers and Distributors – Though this is not typically a major issue at cylinder fill plants, the principles in this publication will be more important in the near future as we implement similar programs for food gases.
- CGA M-8, Guideline for the Manufacturer of Calibration Gas Standards Used to Analyze Medical Gases – M-8 gives clear guidance about how to make acceptable calibration gases for medical gas instruments. This is being rewritten right now. Be sure to download the update when it is published.
- CGA M-10.2, Food Safety Management Systems and Good Manufacturing Practices for Food Gas Manufacturers at Cylinder Filling and Small Bulk Locations – This represents the only published interpretations of food gas regulations for our industry. This is also being completely revised and renamed for the new Food Safety Modernization Act. Look for a new CGA F-1 to replace this publication.
- CGA M-14, Guideline for Bulk Liquid Oxygen and Bulk Liquid Nitrogen Trailer Change of Grade – If you have a bulk medical gas trailer, you need this publication to help decide how to change the grade of your bulk transport.
- CGA M-14.1, Bulk Trailer Change of Grade Validation Protocol – This publication provides the actual protocol used to change a bulk trailer product grade. (Note: GAWDA members participated in development of this publication.)
- CGA M-15, Standard for Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211 – M-15 is the medical gas industry’s latest interpretation of drug regulations. (It is actually our suggestions for rewriting 21 CFR for appropriate medical gas regulations. For example, issues like expiration dating and theoretical yield are rewritten to be useful.)
- CGA M-18, Standard for the Change of Product and Change of Grade for High Pressure and Refrigerated Liquid Containers – This item is nearly ready for publication. Be sure to download it as soon as it becomes available.
- CGA PS-42, CGA Position Statement on Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211 – This position statement is essential for all medical gas firms. It clearly explains the rationale our industry has for changing 21 CFR to be appropriate for medical gases. If you have an FDA inspection, this publication will help explain our position.