1. Authorized Procedures – Verify that your SOPs have been authorized in writing by your Quality Control Unit.
2. Following SOPs – Be sure that your cylinder filling personnel are strictly following the authorized procedures. This is easily accomplished by taking a copy of the cylinder fill procedure to the manifold and watching the operator fill the cylinders.
6/1/14 – Micro Audit
1. Annual Records Review – Verify that you have looked at your records to determine if changes are needed in your medical gas program. This review can be easily completed and documented. Contact Tom if you need a form to document your annual records review.
2. Electronic Registration and Listing – Be sure your electronic registration and listing is correct. Print out the web pages with your information below to document your compliance:
Facility Registration - http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
Drug Listing - http://dailymed.nlm.nih.gov/dailymed/search.cfm
5/1/14 – Micro Audit
1. Dead Ring Test – Verify that the dead ring test is actually being performed on high-pressure steel oxygen cylinders. Of course, the dead ring test should not be performed on aluminum cylinders. This simple item has appeared in recent FDA audits.
2. Certificate of Analysis (CoA) – Be sure that the CoAs you receive for your bulk medical product and for your Servomex span/zero gas cylinders have the following mandatory items:
• Name and address of the calibration standard supplier
• Name of the product
• Lot number or unique identification number specific for each cylinder
• Analytical methodology used to assay the calibration standard
• Actual analytical results (for example, 99.9 percent nitrogen)
• The responsible person’s signature and the date signed
4/1/14 – Micro Audit
1. Annual Record Review – Verify that you have conducted and documented an annual records review for your medical gas production facility. Contact tom@asteriskllc.com for a sample form to easily document this requirement.
2. Food Receipts – Be sure that your food gas bulk receipt paperwork documents that you are receiving food or beverage grade product into your bulk tanks which are used to produce food gases (especially CO2 and N2)
3. Food Lot Numbers – Be sure you are using lot numbers on food grade gases. You must also have a lot number record of food gas shipments. This lot number record may be kept electronically.
3/1/14 – Micro Audit
1. Servomex Filter Check – Verify that the filter inspection record is current for your Servomex oxygen analyzer. The frequency of inspection is listed in the operator’s manual for your instrument.
2. Calibrations – Be sure that your thermometers, vacuum gauges and high pressure gauges are calibrated according to your SOPs.
3. Daily Vacuum Gauge Verification – Be sure you have a record that your vacuum gauge needles read zero at atmospheric pressure. This record should be made each day the vacuum gauge is used.