Merging ISO 9001 and cGMPs: Models for Pharma Already Exist

FDA has just released a guidance document (FDA Quality Systems Document )for implementing a “Quality Systems” approach to GMP regulations, focusing on 21 CFR parts 210 and 211.  One key point is that cGMP regulations should be harmonized, as much as possible, with other widely used quality management systems, including ISO 9000 and FDA’s own medical device quality system regulations. “With the globalization of pharmaceutical manufacturing, and the increasing prevalence of drug- and biologic-device combination products, the convergence of quality management principles across different regions and among various product types is very desireable.”

FYI.  Some models already exist, although you may not have heard of them.  One is ISO 15378:2006, in force since March, and developed for primary pharmaceutical packaging.  It took five years to take shape, and involved input from GMP experts in Europe, in the U.S. as well as a top former inspector for the MHRA. The standard will eliminate contamination, mixups and errors by establishing a benchmark that includes cGMP requirements for documentation, benchmarking, training, auditing and certification. Some of its language can even be applied to secondary packaging.

Tabriz Consulting’s director, Afshin Hosseiny, formerly with Glaxo-Smith-Kline,  and his colleague Tony Harper, both of whom were very closely involved in developing the new ISO standard’s language,  offer a training seminar on this topic next month in Barcelona that’s worthy of note.

And, Hosseiny says, there was even a precedent for this standard with PS9004, a guidance doc that harmonized ISO and GMP language. (File was too big to upload here, so visit this link to get it). For additional information, visit www.tabrizconsulting.co.uk.

-AMS

FDA Releases Guidance on Cell-Based Vaccine Manufacturing

“The guidance document ( Cell_Based_Vaccines_Guidance_Doc )released today is a vital part of our overall efforts to help manufacturers develop new vaccines that are critical to meeting global public health needs,” said Acting Commissioner Andrew von Eschenbach, M.D., Food and Drugs. “This guidance promises to help modernize the development of life-saving vaccines for influenza and other diseases and facilitate the development of more plentiful, reliable supplies.”

In the guidance, FDA provides manufacturers of viral vaccines with updated recommendations to the 1993 document “Points to Consider in the Characterization of Cell Lines Used to Produce Biologics.” The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines. It also provides information on testing at different stages of production and quality-control test methods for cell substrate and adventitious agent issues.

Are Pharma’s Lean Projects Having ANY Bottom-Line Impact Yet?

We just did some research for a capital spending report that will be published in October’s issue of our magazine.  Since we had to dig through annual report data, we thought we’d do a bit of “additional” research on efficiency, to see whether pharma’s lean programs are having any impact on the bottom line.

We took “cost of goods sold” data for each of the world’s leading pharma companies and divided that by average inventories to get “inventory turns,” the figure that automotive and other companies use to figure out how efficient they are. We then averaged them to determine how lean the industry’s becoming.

Admittedly, this was kind of “back of the “excel” envelope” and not a scientific process (we will be cleaning this up and refining it) but the results were  surprising.  Big pharma’s collective inventory turns average 2….a fraction of what they are in other industries.

We looked at numbers from Pfizer, J&J, GSK, Novartis, Sanofi-Aentis, AstraZeneca, Abbott, Merck, Wyeth, Lilly, Amgen, Schering-Plough and Genentech.  Surprisingly, Abbott Labs, which has been the most “low key” about its Lean programs, scored the highest for 2002, 2005 and 2006.  J&J was the winner for 2003 and 2004.

Here are the rough numbers: 

bIG pHARMA’S iNVENTORY tURNS	2000-2006
2006 (BASED on 6 months)	1.94
2005	2.32
2004	2.03
2003	1.82
2002	2.03
2001	2.33
2000	2.07

I couldn’t believe this figure, so I checked Industry Week’s two-year-old results.  They showed a value of 4, but their data includes medical device manufacturers’ data, and those companies are ahead of the Lean curve (after all, they’ve won Shingos, Baldriges etc). Data from Tunnell dating from 2004 indicated that two is Big Pharma’s  magic number, after all.

I’ve visited, first hand, some drug manufacturing facilities owned by quite a few  of these companies.  They’ve made huge progress with Lean, and their efficiency levels approach those of lean plants in other manufacturing sector facilities.  Are each of their operating  companies’ other plants  so inefficient that they obliterate  the impact?

Stay tuned for more on this.  We’ll need to get data from more companies and we’ll do some ‘quality control’ on the data.

Perhaps it’s too soon to expect an impact from pharma’s Lean projects, since some of these programs are only a few years old.  But we’ll be monitoring this closely and posting a “real” index, quarterly. 

-AMS

The Race Against Japan: A Modern Fable

A little levity (no offense intended, although it may strike a nerve)….

A Japanese company (Toyota) and an American company (General Motors) decided to have a canoe race on the Missouri River. Both teams practiced long and hard to reach their peak performance before the race.

On the big day, the Japanese team won by a mile.

The Americans, very discouraged and depressed, decided to investigate the reason for the crushing defeat. A management team made up of senior management was formed to investigate and recommend appropriate action.

Their conclusion was the Japanese team had 8 people rowing and 1 person steering, while the American team had 8 people steering and 1 person rowing. So American management hired a consulting company and paid them a large amount of money for a second opinion.

They advised that too many people were steering the boat, while not enough people were rowing. To prevent another loss to the Japanese, the American’s rowing team’s management structure was totally reorganized to 4 Steering Supervisors, 3 Area Steering Superintendents and 1 Assistant Superintendent Steering Manager.

They also implemented a new performance system that would give the 1 person rowing the boat greater incentive to work harder. It was called the “Rowing Team Quality First Program,” with meetings, dinners and free pens for the rower. There was discussion of getting new paddles, canoes and other equipment, extra vacation days for practices and bonuses.

The next year the Japanese won by two miles.

Humiliated, the American management laid off the rower for poor performance, halted development of a new canoe, sold the paddles, and canceled all capital investments for new equipment. The money saved was distributed to the Senior Executives as bonuses and the next year’s racing team was outsourced to India.

Puerto Rico Breaks Ground on New Biotech Training and Scaleup Facility

While Ireland readies its NBIRT biotech training, research and scaleup facility, Puerto Rico has just broken ground for a similar facility of its own. 

Pharmaceutical Firms Shore Up IT Security

As you already know, pharma is a top target for phishing and IT scams, and more companies are investing in hiring “chief security officers” to prevent electronic trade secret theft and other problems. In case any of you missed it, here is an excellent paper, based on a survey of pharma executives by Deloitte, outlining challenges and best practices.

Pfizer’s New CEO on the Industry, Opportunities, Challenges

Pfizer’s CEO talks to investors You can hear the actual webcast by clicking on http://www.veracast.com/webcasts/bas/36th-annual-2006/id94310181.cfm Those analysts appear to be an even tougher crowd to warm up than pharma professionals (if that is possible).  His McDonald’s anecdotes didn’t even elicit a snicker from the audience. One interesting note (typical for many big pharma companies): increased attention on biopharma BLOOM (BLOOM), National Wed 20 Sep 2006 04:36 PM EDT Bloomberg didn’t carry any video footage, unfortunately, but in this clip Suzanne O’Halloran summarized developments

Von Eschenbach Sees Personalized Medicine as the Industry’s Future

Acting FDA Commissioner Andrew Von Eschenbach made the comment last week in a speech he gave at the “Pharmaceutical Forum,” the first in a series of lectures that will be held at Seton Hall University.  Here’s a brief report. The forums will be held twice a year, and we’ll keep you posted on what’s covered.

-AMS

Pfizer’s New CEO to Speak This Afternoon. Stay Tuned

For the curious, Bloomberg will be covering a speech that Jeff Kindler’s scheduled to make this afternoon at 3 (EST), and we’ll post the video clip here.  Here’s a prelude.

Pfizer’s Kindler Speaks BLOOM (BLOOM), National Wed 20 Sep 2006 01:42 PM EDT Jeff Kindler, Pfizer’s new CEO, speaks today at 3 EST, and Bloomberg will cover his speech.

Top 10 Pharma’s Profits Up $8 Billion from January to June, Waxman says; Rep Vows to Support Biogenerics

U.S. Representative Henry Waxman has just analyzed the profitability of the world’s 10 pharmaceutical companies, and finds that their profit margins increased by $8 billion over the first half of this year. (waxman_report_on_drug_profits.pdf)

He attributes that to the new Medicare Drug Program and such things as “induced demand” and a failure to limit drug price increases.  In a speech today before the Generic Pharmaceutical Association today, Waxman said he plans to prod FDA to set clear guidelines that could speed the approval of biogenerics.  Read here for the report from Associated Press.

-AMS