Author: Thomas Badstubner

Editor’s Note: This column can serve as a companion article for the Consultant’s Roundtable on page 14. Admin – CGMP Training – Online Training Resources Food and Medical Gas – CGMP Training for Administrative Personnel Visit research.net/r/QuizforGMPTrainingforAdministrativePersonnel  11-minute video presentation The essential FDA regulations for administrative personnel Essential GMP regulations Lot number tracking Complaint procedures Quiz Certificate of participation Food Gas – Online Training Resources Food Gas – Qualified Facilities and Submitting the FDA Attestation Visit bit.ly/2T2CTGF to view the Food Gas Roundtable recording discussing the FDA Qualified Facility exemption and how to submit the Attestation. 15-minute video presentation The FDA…

Specialty, Industrial, Food and Medical Gas Safety Alert Mixtures containing Carbon Monoxide & Carbon Dioxide in steel cylinders This GAWDA Safety Alert is issued to inform GAWDA members of potential cylinder damage resulting from internal stress corrosion where carbon dioxide and carbon monoxide are filled in steel cylinders. In the past, cylinders have violently ruptured causing significant damage. Carbon monoxide and carbon dioxide are present in many mixtures. Recently, food gas mixtures (meat processing gas) and laser mixtures have been widely produced. If you are filling mixtures containing carbon monoxide, carbon dioxide, with or without other balance gases, in steel…

In recent years, the Food and Drug Administration (FDA) has increasingly observed violations involving data integrity during audits. Data integrity issues have been observed in traditional pharmaceutical firms as well as in medical gas firms. Solid, accurate and reliable data is an important component to ensure compliance with FDA’s Current Good Manufacturing Practice (CGMP) regulations. The integrity of drug (and food/beverage/device) manufacturing data is also critical for your own business success. What is “data integrity”? Data integrity refers to the completeness, consistency and accuracy of data. The data integrity term ALCOA stands for Attributable, Legible, Contemporaneous, Original and Accurate. What…

The FDA and state regulations recognize the traditional distribution of typical prescription drugs: This distribution model works well for traditional drugs. The FDA, state Boards of Pharmacy and regulations are well structured to efficiently manage traditional pharmaceuticals. These structures are not necessarily perfectly formed for medical gas distribution. From the drug manufacturer to the wholesale drug  distributor to the pharmacy to the patient. Typical pharmaceuticals are: Relatively dangerous Expensive Have a container that is inexpensive and disposable Subject to counterfeiting for economic advantage Subject to diversion from established distribution channels to internet and unlicensed sales Manufactured by relatively few, large…

What is the Latest FDA Thinking About Expiration Dates on Medical Gases? 21 CFR 211.137(a) clearly states that drugs must bear an expiration date. However, this does not represent the latest agency thinking or enforcement regarding expiration dating of medical gases. Enforcement Discretion We have three recent examples of FDA communication regarding expiration dates: In a message from the FDA to a medical gas firm, the agency stated: The agency is currently developing guidance pertaining to stability testing and expiration dating of medical gases. Pending publication of FDA guidance on this subject, our policy has been to use enforcement discretion…

Successful specialty gas professionals consistently use sales techniques and systems to increase their performance. Of course, it is essential to understand the chemistry, operations and distribution of your products. However, long-term success requires attention to the systematic behaviors that keep new, profitable prospects in the sales pipeline. Here are examples of key systematic behaviors I have observed from the best specialty gas sales professionals. Respect and Thank Your Customer – Ed Pyle You worked hard to find and cultivate your valued customer. You genuinely appreciate the trust he/she places in you to solve their problems and contribute to their success.…

By: Jack Hercik, Asterisk, LLC A recent series of advisories and safety alerts have been issued by various government agencies and industry associations warning of the risks associated with products prepared with liquid nitrogen at the point of sale. (See references, below.) These include confectionery products marketed as ‘Dragon’s Breath’, ‘Heavens Breath’, ‘nitro puff’ or other similar market names. These products include cereals, snacks and alcoholic and non-alcoholic drinks infused with liquid nitrogen that emit a misty fog like vapor simply as a novelty. These applications have resulted in a growing number or reports of serious injury to unwitting consumers…

Effectively training your employees can accomplish several important goals: regulatory compliance, standardization, employee performance improvement, loss reduction and profit improvement. GAWDA members have access to a variety of training resources and training formats. Select the format that best meets your business requirements. GAWDA University GAWDA U Online is an employee training curriculum and management tracking protocol that addresses many of your training needs in the areas of compliance with safety practices and government regulations, which are impacting your core business. GAWDA University is facilitated by Norco, a GAWDA member. To sign up for the program, send an email to Michelle…