Installment 1
Oscar Wilde once wrote that "moderation is a fatal thing. Nothing succeeds like excess."
Installment 1
Oscar Wilde once wrote that "moderation is a fatal thing. Nothing succeeds like excess."If that's true then Las Vegas has to be one of the world's greatest success stories. Vegas is where the otherwise buttoned down and sedate ISPE held its 2007 meeting. For any of you who couldn't make it, here is a brief roundup of impressions and reportage from the conference from a first-time visitor to Vegas.
Second connecting flight was made pleasant by an aisle seat and a Southwest Airlines steward who did a mean Elvis impersonation and all but sang his safety instructions (and well, too), punctuating the flight with one liners and a bit of standup comedy.
However, I started to feel l a bit like Rain Man right in the airport, where the uninitiated visitor is greeted by yard after yard of slot machines. It was only 6 PM, yet few of them weren't occupied. It brought out my inner Ayatollah.
The meeting was held at Caesar's Palace, which, like Vegas itself is a monument to good old American one-upmanship. You like the Caracalla baths? We got `em. Only new, shiny and 10 times larger.
You want Venice,Paris, New York? We've got it all"¦we'll give you your gondolas, the Eiffel Tower and the Empire State Building, and within walking distance, too.
Actually, the "Pool of the Gods" (click here for a virtual tour, and imagine Danny De Vito as Zeuss--er, Jupiter.) is quite amazing, and the ISPE exhibition hall was right next to it. Attendees received their cardiovascular exercise dashing from keynotes on one floor to sessions on another, to posters and the exhibit floor by the pool.
This year's conference theme was "Delivering today, transforming tomorrow," but at least one speaker (Uri Boneh, Director of Global Engineering at Teva) brought out the fact that transforming tomorrow is already a bit late. The industry must begin this transformation today.
ISPE's Product Quality Lifecycle Initiative PQLI effort is an important step in the direction of reshaping pharmaceutical quality systems. Unfortunately, I could only spend one day at the conference and had to miss reporting on the PQLI meetings, which included Moheb Nasr and Joe Famulare of FDA
By all accounts, some companies are starting this transformation and ISPE is doing what it can to nudge the industry toward its next (warning: oncoming business cliché!) paradigm shift, by expanding globally and incorporating science (especially as it concerns biotech) into its traditionally engineering-centered focus.
Vice Chairman Bruce Davis discussed ISPE's recent MOUs with a key Chinese pharmaceutical organization, as well as an upcoming meeting with the Pharmaceutical Inspectorate (still looking over FDA's application), or PIC/S, in Singapore. The excellent Journal of Pharmaceutical Innovation, which was originally to have been a quarterly, was only published once last year, a shame. However, Mr. Davis assured the audience that two or three new issues are expected next year.
[Aside - Could a new publishing partner help? A journal like this should be published regularly and I know of an excellent prospect, based in the Chicago area... ]
ISPE is updating its API guide, its pharma water and steam systems good practice documents, and new baseline guides for packaging, maintenance, quality lab facilities. Also upcoming is guidance for the risk-based manufacture of active pharmaceutical products, or Risk-MaPP, which covers cytotoxic compounds.
As Davis said, it will "talk logically about emotive issues and balance GMP issues with those of operator health and safety." Updates are also expected on oral solid dosage forms, sterile manufacturing, water and steam systems, and installation and verification. Next year will bring updates on GAMP series, GAMP 5, MES, validation of process control systems, calibration management, as well as good engineering practices for HVAC.
That's it for now"¦
AMS
