It concluded much more favorably than anyone involved had anticipated. From the organizers to the attendees, everyone I spoke with agreed that the event exceeded their estimates and expectations. Registrants got their money's worth, the PDA gained new members and the PCCDG increased its momentum and credibility among the industry and the world's leading pharmaceutical regulatory agencies. Even the jaded and hard-to-please came away from this week's conference satisfied.

The relevancy and quality of content from the presenters surprised many. Much of that credit has to go to Bob Dana, Vice President Quality and Regulatory Affairs, PDA; and the highly respected PDA-PCCDG chair, Rafik Bishara, who used their significant influence, dash and charm to coerce even the most stubborn leaders within the pharmaceutical cold-chain industry to "volunteer," moderate or present at this inaugural conference. This was most evident by convincing the elusive FDA to attend and present. (See March 27th posting: Regulators Comment on Technical Report No.39, Shipping Outside of Label Claim and Monitoring).

In addition to the recap of events outlined in that posting, the highlights of the two day  event were:

The chairs of the European Cold Chain Committee (C3) and the Pharmaceutical Logistics Forum (PLF) attended and agreed to begin a dialog with the PCCDG on unifying efforts.

The endless stream of presenters referencing TR 39, the need for current good distribution practices (cGDP), quality agreements, procedures, training, and above all, good science.

The importance of including distribution temperature cycling studies as part of the overall product stability study programs.

The importance and advantage of including such studies in PLA filings.

The hope of the PDA was to have 75-80 in attendance. A total of 116 people registered. 10 exhibitors, all directly involved in cold-chain, helped sponsor the event. The PDA staff were extremely well organized and efficient. The hotel, if not a little inconvenient to the area's 3 airports, was elegant, the food a few notches above most and the venue was dramatic and spacious. The IT/AV crew never left the room and not a single technical mishap occurred.

The goal, of course, was to educate, inform, increase awareness of and involvement in, cold-chain. In my opinion, it was a home run!

If any of you who were in attendance have comments to make about the conference, or ideas and suggestions for improving the next meeting, why don't you share them with us? I'm sure the PDA and the organizing committee would appreciate the feed-back too.

* * *

I suspect the next PDA-PCCDG conference will outdistance this one. There is talk of a European meeting and making the Bethesda summit an annual event. My, how far we have all come in cold-chain in a few short years!

The much anticipated PDA Pharmaceutical Cold-Chain Management Conference concluded its first day of activities in Bethesda, Maryland today. Keen interest was paid by the 116 attendees on the FDA's first public acknowledgment of Technical Report No. 39, Cold-chain Guidance for Medicinal Products: Maintaining the  Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment.

There were three regulating authorities among the presenters:

John Taylor, Quality Systems Manager of the MHRA (UK),

Vincent Tong, Compliance Officer, GMP Inspection Unit, Health Canada and

Nicholas Buhay, Acting Director, Division of Manufacturing and Product Quality, Center of Drug Evaluation and Research, FDA

In addition, there was one compendial affairs presenter, Claudia Okeke, PhD., Associate Director General Policies and Requirements Division, USP.

Each of these regulating authorities reiterated the need for good distribution practices, policies, procedures, training and adherence to their own governmental guidance and requirements documents. They are remarkably similar in content but enforcement varies as the meaning of the word "guidance" differs from country to country.

Mr. Taylor's presentation was, as always, button-down and to the point.

Mr. Tong's soft spoken and calculated presentation revealed no surprises as most are now familiar with HC's stringent regulation enacted last fall.

Ms. Okeke gleaned a pertinent few slides from her usual USP overview to deliver a well focused differentiation on the organization's mandatory requirements vs. guidance documents.  

Mr. Buhay glided through FDA's expectations of compliance with a well prepared and sanitized presentation. However, he was remarkably non-committal and vague during the question and answer session as he carefully negotiated the regulatory waters with nearly incomprehensible double-speak. He did relinquish a glimpse into the mind-set of the agency when he stated that "in the future, the lack of temperature cycling studies will result in deficiencies".

On the bright side, he did state that when it came to the efforts of the PCCDG to promote and implement good distribution practices for the transportation of temperature sensitive products "the agency was quite satisfied with current level of activity" and alluded to areas of greater concern to the agency than what takes place in our little cold-chain corner of the world.

* * *

At the conclusion of their presentations, the regulators were asked to comment on several questions  from a captive and information-starved audience desperate for guidance. Most notable were two questions that PCCDG members have agonized over and discussed adnausium at every conference:

Q: does your agency allow shipping product outside of label claim provided there is sufficient stability data to support it?

Taylor: Yes, it is allowed by the MHRA provided it has been reviewed by the regulatory authority and an application for variance has been submitted.

Tong: Yes, it is allowable with supporting stability data and the consent of the fabricator (manufacturer).

Buhay: Yes, with supporting stability data.

Okeke: Yes, as long as cycling studies have been performed and support it.

Q: Is it necessary to monitor every shipment if validated packaging is used in a qualified distribution process?

Taylor: No. Periodic monitoring is acceptable

Buhay: No, as long as you can show control of your process and the occasion with a program that organizes your rationale.

* * *

Overall, the panel were pleased with our efforts and encouraged us to proceed with developing additional industry guidance. The panel, at the invitation of committee chair Rafik Bishara, agreed to meet in the future with the PCCDG to address concerns they might have regarding future guidance. In all, it was a good day.

If any of you are planning to attend the Pharmaceutical Manufacturing Conference & Exhibition, Interphex, next week at the Jacob Javits Convention Center in New York City, stop by Booth P 2056 on Tuesday the 21st or Wednesday the 22nd and say hello. I'll be passing through on those days and we can chat about the blog and perhaps I can get your thoughts on a research project I've been working on.

The first PDA Cold-Chain Management Conference will be held at the Bethesda North Marriott Hotel & Conference Center on March 27th & 28th, 2006.

By taking an in-depth look at the factors affecting the cold-chain management of pharmaceuticals, the conference will feature 8 plenary sessions providing guidance on how to effectively implement technologies and quality systems within regulatory requirements and public standards to guarantee the safety, efficacy and quality of pharmaceutical products.

You can click here for a pdf. version of the current agenda.

I spoke with Rafik Bishara, PhD., Program Chair of the event this morning. He informed me of a couple of updates. Hugo Wegewijs, Chair of the European C3 will also be presenting a European perspective. Unfortunately, Chris Landauer, Senior Validation Engineer, Amgen, had to withdraw due to a last minute priority and as a result, Rafik will lead the session on Quality Standards.

I have been involved with this event as a planning committee member and will act as moderator at one of the sessions. It will be refreshing to see many new members involved, presenting fresh ideas, topics and procedures in an effort to continuously upgrade cold-chain distribution practices.

PDA Members and non-members can register on-line here.

I look forward to seeing you there!

According to my partners in cold-chain at Sensitech, there has been an overwhelming response to their FREE webinar on The Impact of USP General Chapter <1079> on Cold-Chain Management. Currently, 125 participants are registered. There is a finite number they can accommodate and only a few spaces remain for the March 16th, 2:00 pm (EST) event. 

As mentioned in my February 16th posting, anyone participating in the manufacture, storage, distribution, and shipping of temperature sensitive pharmacopeial products needs to familiarize themselves with this document . This is a perfect opportunity. You can link directly to Sensitech's webinar registration page here.