A 483 citation is the FDA equivalent to a moving violation - too many moving violations and you run the risk of losing your driving privileges. It's not so different in the pharmaceutical world - only the fines and the consequences are far more serious.

There are those who still carelessly drive 50 m.p.h. through a school zone and believe they will not get a ticket just as there are those in the pharmaceutical industry who choose to ignore regulatory requirements in distribution and think they will not be audited.

In an article from the archives of American Pharmaceutical Review entitled Cold Chain Management - An Essential Component of the Global Pharmaceutical Supply Chain, Dr. Rafik Bishara, chair of the Pharmaceutical Cold Chain Discussion Group of the PDA takes a hard look at the increased importance of pharmaceutical cold chain management as a result of increased global regulatory oversight in the distribution channel.

Dr. Bishara has sifted through countless 483 observations by the Agency, which are a matter of public record and available through the Freedom of Information Act, and gleaned and sanitized those related to cold-chain distribution. He doesn't say what percentage they represent of all 483's given but a similar statistic from the MHRA shows that of Critical/Major Citations for Distribution Deficiencies issued in the UK in 2003-2004, nearly 25% were related to temperature control and monitoring.

You can read Dr. Bishara's article in its entirety here. I have added a Bibliography category to the column on the left to which I will soon be adding similar published articles and links. If you know of others that would be of benefit to readers of this site, please let me know, post a comment, or e-mail me directly at kevin.o'donnell@sca.com.  

A note about sending solicited/unsolicited material: If you are a regular reader, you know that I do not use this venue to promote or endorse any company, including and especially my own. Nor do I criticize or judge any company, product or person. If a company, product, publication or individual is named and a link provided, it is only because it is integral to the posted article. I maintain a strict adherence to this policy as this blog is a resource meant to educate and inform those involved in pharmaceutical cold-chain and engage readers in an interesting and entertaining way.

 

I've put together a listing of up-coming cold-chain conferences. They range from one day events, kicking-off multi-day supply chain summits, to four day extravaganzas. They vary in content, scope and cost. Some are more high-level supply chain oriented while others focus on current best practices. They include workshops, round table discussions, security issues, industry case studies, wholesaler perspectives and regulatory presentations. You can find more detail at their respective web site links below.

 

July 24-26 Seamless Pharmaceutical Cold Chain Distribution Conference, Philadelphia, PA  www.marcusevansbb.com/coldchain

Change of venue. Originally slated for San Diego, this was recently moved to Philadelphia. A look at ways of maintaining unadulterated medicinal products through the supply chain.

 

August 7-9 Pharmaceutical Supply Chain Integrity, Tyson's Corner, McLean VA  www.traxsummit.com

A one day cold-chain symposium, August 7Th. I will be chairing this event in McLean, VA. The focus will be on changing distribution models for cold-chain pharmaceuticals, the role of stability data in the shipping process, a look at risk management in shipping and distribution, working with 3PL's, and understanding key decision points in thermal package development. The day will wrap with a panel discussion on the evolving global challenges of cold-chain pharmaceutical distribution.

 

September 11-15 2006 PDA / FDA Joint Regulatory Conference: 10 FDA Speakers Confirmed Washington, D.C. www.pda.org/Connector

Not related to cold-chain specifically, but insight to the agency's current views on cGMP, ICH Q8, Q9, Q10, quality systems, regulatory inspections with individual plenary sessions focused on quality, manufacturing and regulatory.

 

September 18-21 LogiPharma 2006, Austin TX  www.logipharma.com

The Cold-Chain Management Summit occurs the first day. Adopting best practices for the storage, packaging, and distribution of temperature-sensitive pharmaceutical products and communicating the most recent cold-chain regulations and guidelines for compliance.

 

September 25-28 4Th Annual Cold Chain Distribution for Pharmaceuticals, Philadelphia, PA  http://www.iqpc.com

Day one: a plethora of workshops. Day 2, morning: presentations on global cold-chain management, state of innovations in distribution and hospital requirements for distribution. Afternoon: Track A distribution, Track B packaging. Day 3 morning: the fun continues with regulatory updates. The afternoon: Track A quality, Track B global cold-chain. Evening: dinner workshops - seriously. Day 4: post conference workshops in RFID and contingency planning.

October 5-6  Inaugural PDA / PCCDG  European Meeting and Working Session, Berlin, Germany

I heard from Dr. Rafik Bishara, Chair PDA / PCCDG,  today who asked if I would post this to the blog. It will be the first European working meeting which will include the C3, the PLF and other countries interested in developing global cold-chain guidance. More on this in the weeks to come.

October 10-13 PDA / EMEA Joint Conference, London, England www.pda.org/Connector

A unique opportunity to meet and mingle directly with top European heath authorities and industry representatives in a neutral, science-based forum.

 

It's been on the block for a while and announced today. Carrier's long history of cold storage and transportation, particularly in the food industry, is branching into the growing need for such services in the pharmaceutical market. Sensitech's strategic leadership in monitoring with high growth potential in the cold chain monitoring / data management market makes this a marriage made in heaven. You can read the press release here.