GAWDA Medical Gas Consultants
New Announcements
7/1/08 – The CGA submits comments on potential safety issues related to the transfer of oxygen equipment assets to patients in accordance with provisions established in the Budget Reconciliation Act of 2005 in response to an invitation by members of the US Congress
3/1/07 – FDA publishes proposed changes in Medical Device Classification for Oxygen Regulators, including integrated valve & regulator devices.
10/11/06 – “7 Most Common cGMP Violations”
7/6/06 – The Cost Estimates of Compliance with the Proposed Rule
7/5/06 – After three months of diligent effort, GAWDA and CGA have developed and refined a detailed set of comments in response to FDA’s proposed new regulations for medical gas mix-ups. This 22 page GAWDA / CGA joint comments letter can be viewed here.
May 18, 2006 – GADWA FDA Compliance Update Teleconference Audio
GADWA FDA Compliance Update Teleconference PowerPoint presentation
April 19, 2006 – FDA proposes new regulations on Medical Gas Container and Closures
11/3/05- FDA Update Web Conference featuring Bob Yeoman & Ron Ball
To listen to Recording right click and choose save target as Gases & Welding 11-03-05 196302.mp3
In order to listen to this recording you will need an mp3 player.
GAWDA recomends using either iTunes or WinAmp.
Mac or Windows: iTunes
Windows: Winamp
Download Presentation Slides
11/2/2005 AHCA Eases Oxygen Refill Requirements
3-15-05 USP postpones planned revisions to the medical gas monographs.
3/9/05 – GAWDA Files Comments with FDA and USP/NF
GAWDA and CGA have filed comments with FDA and USP / NF on the recent changes to the medical gas monographs. GAWDA is working hard on behalf of our members to achieve an acceptable resolution to this issue. Further information will be provided as it is available. For more information on the proposed USP changes contact the GAWDA medical gases consultants – B&R Compliance Associates, or join over 70 other GAWDA members at the Compliance training seminar in Indianapolis, IN March 30th.
3/1/05 – GAWDA and B&R Compliance announce revisions to Medical Gas SOP Manual
2/11/05 – USP / NF implement major changes in the testing requirements for Nitrogen NF and Nitrous Oxide USP.
3/2/04 – FDA has released its “Final Rule” document on “Bar Code Label Requirements for Human Drug Products and Biological Products”. Medical Gases have been specifically exempted from the requirement.
12/18/03 GAWDA and CGA Settled Pressure Regulatory Initiative
GAWDA and CGA met with senior DOT officials last month to propose an initiative to lead to a resolution of the not uncommon practice, in violation of DOT rules, to purposely overfill cylinders with compressed gases in order to assure that the cylinder is filled at least to the cylinder’s stated service pressure at 70ºF. A joint letter from CGA and GAWDA to the membership is attached, and explains the initiative in detail. Pending results of the initiative, DOT will exercise “broad enforcement discretion.” However, “DOT requested that CGA and GAWDA notify their members that overfilling compressed gas cylinders will not be allowed and that companies should review their filling procedures to ensure that they reflect DOT requirements, for example 49 CFR 173.301a and 173.302a.” Click here for the explanatory letter.
10/23/03 CGA/GAWDA Comments Regarding Draft FDA Guidance for Industry on the cGMP for Medical Gases
10/20/03 – FDA has released the procedures for registration of food and food ingredient production facilities. GAWDA members can click on the following link and follow the instructions to register their firm. To determine if your firm is required to register download and review the Bioterrorism presentation teleconference slides. http://www.cfsan.fda.gov/~furls/ovffreg.html
9/26/03 – FDA has released an updated version of their guidance document for field inspections of medical gas facilities. While the document does not include any references to the new, draft, guidance document it does provide general instructions on what areas field inspectors should review when at a medical gas manufacturing facility. Members with questions about FDA inspections, or would like some assistance in preparing for an FDA inspections should contact B&R Compliance Associates LLC.
9/4/03 – FDA issues Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application
8/19/03 – FDA introduces new proposed regulations in response to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These regulations will impact gas producers and distributors that sell to the food and beverage industry. You can read and download the full text of the regulation from the above link. CLICK HERE for recent teleconference handouts.
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Recent Articles and Information
Beware – Cylinder Contents | April, 2010
USP Update – No News is Good News | March, 2010
Train-the-Trainer CGMP/DOT Training in March 2010 | February, 2010
Update on Electronic Registration and Listing | January, 2010
Breathing Air | December, 2009
Servomex PM Program | November, 2009
Update on Electronic Registration and Listing | October, 2009
New Electronic Registration and Listing | September, 2009
USP/NF Proposed Revisions | August, 2009
USP/NF Proposed Revisions | July, 2009
Your Standard Operating Procedures (SOPs) | June, 2009
Certificates of Analysis | May, 2009
Daily Settled Pressure Test | April, 2009
USP Update | March, 2009
State Regulations | February, 2009
FDA Drug Registration | January, 2009
Sharing Validations… | December, 2008
Drug Pedigree Update in Texas | November, 2008
Making your own destiny – Action in Texas | October, 2008
Assessing FDA Compliance: Ten Questions | August, 2008
Documentation of Annual Management Program Review & Internal Audits | July, 2008
FDA Annual Registration & Drug Product Listing Requirements | June, 2008
Quality Records | May, 2008
Part 11, Electronic Records: Electronic Signatures (A series of Articles) | March, 2008
Part 11, Electronic Records: Electronic Signatures (A series of Articles) | February, 2008
Part 11, Electronic Records: Electronic Signatures (A series of Articles) | January, 2008
Part 11, Electronic Records & Part 1: Background/Current Status | December, 2007
Adverse Event Reporting and Medical Device Reporting Requirements: | November, 2007
Assessing FDA Compliance | October, 2007
Annual Management Program Review | September, 2007
Re-issuance of Alert: Abusive Use of Nitrous Oxide | August, 2007
Preparing for a FDA Inspection | July, 2007
FDA Annual Registration & Semi Annual Drug Product Listing Requirements | June, 2007
Sale of USP Oxygen & Breathing Air used for Breathing in “Mine Refuge Chambers” | May, 2007
Use of Computers to Track Lot Distribution Records | April, 2007
USP/NF Activity Regarding Medical Gas Monographs | March, 2007
Sale of NF Nitrogen to Plumbing Companies | February, 2007
Cylinder Preparation | January, 2007
FDA Annual Registration & Semi Annual Drug Product Listing Requirements | December, 2006
Regulatory Initiative Update | November, 2006
“7 Most Common cGMP Violations” | October, 2006
Validation of Alternate Test Methods (ATM) | October, 2006
Vacuum Pump Oils (Selection) | September, 2006
Assessing FDA Compliance: Ten Questions that every Medical Gas Manufacturer should be able to Answer | August, 2006
Cylinder Evacuation | July, 2006
FDA Annual Registration & Drug Product Listing Requirements | June, 2006
MEDICAL GAS ALERT | May, 2006
FDA proposes new regulations on Medical Gas Container and Closures | April, 2006
Leak Detection Fluids (Selection & Proper Usage) | April, 2006
Oxygen Cylinder Cleaning | March, 2006
Investigation of Out of Specification Results – Non Conformance Reports | February, 2006
Labeling Requirements | January, 2006
FDA Annual Registration & Semi Annual Drug Product Listing Requirements | December, 2005
Quality Control Unit (QCU) | November, 2005
Medical Gas Product Integrity Protection in case of Natural Disaster | October, 2005
Preparing for an FDA Inspection | September, 2005
Quality Records | August, 2005
Emergency Oxygen: Drug or Non-Drug? | July, 2005
FDA Annual Registration & Drug Product Listing Requirements | June, 2005
FDA Enforcement Trends | May, 2005
Content Verification (Specified Settled Pressure) What can reasonably be expected? | April, 2005
FDA Related Complaint Handling – What is a Recordable Complaint? | March, 2005
Annual Management Program Review | January, 2005
Gas Applications: Drugs or Non-Drug? | February, 2002
Archived Safety Documents, Regulations, etc
FDA Annual Registration & Drug Product Listing Requirements(12/04)
Nitrogen Open Top Dewar Filling for Medical Us(11/04)
Alert: Cylinder Fill Plant Validation Activities(10/04)
Alert: Abusive Use of Nitrous Oxide(9/04)
Summary Progress Report – Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach – Questions and Answers
Guidance For Industry Part 11, Electronic Records
Medical Gas Mix-Ups Display Information
GAWDA is working with the US. Food and Drug Administration to help communicate the importance of training and following safe practices with regard to medical gases.
Download images to create posters and stickers to remind people working with medical gases of the importance of following established safe practices.