GMP Compliance Basis Blog

even through a change of ownership at a production facility…

Accountability may be an issue…see previous post

Novartis warned as facility fails inspection… 

04/02/2008 - Novartis has been given a warning by US regulators detailing significant failures in its investigation into tracking down the source of contamination in some of its vaccines.

link to full article

Dr. Frank came up with the great idea of convincing the Board of Directors that the Scholastic Highlight Investigational Technology Team review meeting would get combined with a special meeting with potential investors… Dr. Frank is in his glory…the hallways at FEP are awash in investors carrying bags of money looking for a horizontal surface to dump it on…
Dr. Frank decides on a reception room for investment conversation over some cocktails…across the hall will be a buffet, some caviar, some wine…the scientific presentations will take place in the auditorium….
The investors invade…and basically the crowd seems to be made up of three separate groups…
The Sharks…
The biggest group is the Big Pharma guys, …Armani suits, slicked back hair, very manicured look…assistants trailing them around issuing nearly constant press releases about the “on-going positive progress of joint venture discussions” and “value propositions which will resonate in the target market and allow us to generate traction in the business space…” 
These guys are the sharks…buy-outs and mergers are like potato chips to these guys…”nobody eats just one…” each assumes they will get the “big score” if they can just get Dr. Frank out to dinner…these guys are all in the main conference room knocking back martinis, checking their Blackberrys every 30 seconds and networking like there’s no tomorrow.
The Nerds…
The second group of investors, a slightly smaller group, seem to be venture capitalists of some sort…a bit scruffy, for the most part, particularly when compared to the Big Pharma guys…jeans and polo shirts, bad haircuts and some of them look might they might have forgotten to shave…
Mostly everyone is ignoring them, but no one is asking them to leave under the assumption that they must be really successful if they can show up at an event like this dressed like cartoonists.
These guys mostly seem interested in the food…and they give off a carefully contrived attitude that they are way too cool to be interested in the scientific side of the presentation, or, even worse, the business side of the event… they might honor you with the venture funding if they deem you worthy…
The Smart Money…
The last group consisted of 2 or 3 other gentlemen walking around earlier…no one took too much notice…quite, well-dressed in their English Cut suits, well-mannered… they avoided the drinks, the buffet line, the canned presentations, and glad-handing with the helium-breathers…
They were seen spending time talking to actual scientists, asking detailed questions and discussing specific progress against all of the previous FEP hype…last anyone saw these gentlemen walked quietly out of the building, got in their cars, and drove away…they had the answers they came for…an astute observer would have noticed them all talking on their cell phones on the way out…
Stay tuned…

Aftert Phil’s presentation at the Investor Relations meeting, people hustled out of the building, off for the holiday break…Some people spent time with their in-laws…others spent time with their out-laws…dinners were eaten…weight was gained…minor sporting events played endlessly on large-screen TVs…
Just like a lot of things, many people forgot about Phil’s performance over the holidays…
But nobody forgot what happened to FEP market capitalization…
Bonuses were spent…401Ks were stuffed…Options for FEP stock were cashed and the certificates were lovingly wrapped in ribbons and bows and given as gifts to children and grand children…”to get them off to the right start in life…”  you know, kind of like what people used to do with IBM stock…(it was a computer company, a long time ago, trust me…)
The glow was warm, golden, and fueled by over-inflated stock gains based on a story that was rapidly becoming the stuff of legend…
Mollie came back from the holidays with a tan…apparently she spent some time in the tropics…
Other big-time vacations were planned…Lou Da’ Cris booked himself on a Superbowl extravaganza; “I spared no expense…”…Del Lusional talked nonstop about his “trip of a lifetime” to the NCAA Women’s Basketball Championship…other people with plenty of money, but no imagination planned trips to boring places, like Paris…
The parking lot was starting to sprout shiny new cars…the Two-seater Sports cars competing on performance compensation issues…the big SUVs competing with each other for space…
Lavish parties were held…Scientists who used to be ignored at cocktail parties dropped investment advice like napalm…and were shocked when people actually stopped to listen.
Retirement plans were made…People had their meal-ticket punched, and they were on their way out of town…
FEP staff was thrilled to work among the best and the brightest…doing work on the cutting edge of scientific achievement…for an investment industry darling…
Everything was going insanely great…
Until…
The next meeting of the Scientific Hierarchy Investigational Team Meeting…

Best Wishes (belated) for a Happy and Healthy New Year!!!

(back from a long holiday break, and looking forward to the new year…)

A good post regarding upcoming FDA enforcement trends…

 Some interesting points are made…

• Labs and Clinical sites will be targeted
• Integrity of Information is cited in 95% of cases
• Adherence to protocols is also common cause

Specific recommendations from FDA personnel are also included…I thought one of the most interesting was number 2 which references personnels commitment to what they are trying to achieve, not just blinding following procedures

Check it out…link here

Also, check out the Biotech Blog…

The moment has arrived…Phil strides to the podium and grabs the microphone…He can almost here the blare of the trumpets… 

He skips the prepared presentation…they’re for light-weights, anyway… 

Phil starts off with a few jokes…but the natives start to get restless…you can almost feel the undercurrent in the room…what about those financial results, anyway? 

Phil is starting to get warmed up, he is really starting to hit his stride…Hardly stands up to repeat his questions and Phil just waves him back to his seat…Phil begins to babble on about the “big new ideas” that are under development back at the Fun E Pharm. 

“In fact” Phil continues, “they are not only under development, but these new ideas are close producing real results for the Company, the shareholders, and the proud men and women of Fun E Pharm”…a standing ovation follows, women cheer, hardened financial analysts have trouble seeing their double martinis thru tear-streaked eyes…Phil is swimming in his own glory… 

He continues with the announcement of three novel new therapies… 

“All men have to consider…, and who won’t want…” 

“Most women are concerned with…and who wouldn’t want…” 

“Finally,” Phil announces,” we all have a…and who wouldn’t want the comfort of knowing…” 

Dr. Mollie is unable to intercede…unfortunately, she took the boring financial part of the presentation as an opportunity to sneak off to the buffet table…(she loves the chocolate fountain, you know, with the sliced fruit…she really likes the little cookies…) 

It’s too late, Phil is reaching his peak…”We expect that each of these new ideas to be a blockbuster with a market share in the multiple billion dollars range…tens of billions…hundreds of billions…” 

He finishes with a flourish, raises his hands over his head…”Thank You…Thank You…” 

Phil is beginning to disappear into his own fantasy again…Dr. Mollie rushes to the stages, hastily thanks everyone for coming, and ends the presentation…Mollie has to hustle Phil off the stage… 

The media rushes out, snaps open their PDAs…the message goes out…”it’s the next breakthrough!!!…the next blockbuster!!!”…the word is out… BUY FEPh… 

The stock opens that day at an all-time high, and is doubling in value every two hours…three days later, Fun E Pharm shares are trading at levels only Dr. Frank and internet search companies ever dream about… 

Fade to black… 

The stage is set…
literally…
A presentation room has been transformed into a multi-media computer-geek toy-show…online streaming video…satellite feed…tiers of plasma screens…buffet spread…cocktails…
hey, no expense should be spared when you’re spending someone else’s money…
The event coordinator has done a great job…Fun E Pharm presentations are known throughout the industry for being extravagant affairs…open bar…amazing food…great give-aways…
A big banner hangs over the stage…”Welcome to Investor Relations Day…”
Models dressed in lab coats greet people as they walk into the presentation room…
(the safety glasses are a nice touch…they make everybody look smart…)
Off to the side there is also another screen which lists the agenda for the entire event
Fun E Pharm
Investor Relations Day
—————————————————–
- Welcoming Remarks
- 3^rd Quarter Financial Results
- Keynote Address- “Present Direction of Progress for Scientific Highlight Initiative Teams”
- Investor Discussion
- Closing Remarks
————————————————–
The event is about to get underway… and things look like they’re getting off to a good start…the assembled crowd has had a chance to stuff their face, and down a few quick drinks…
The media has gathered…Hardly Firestein arrives… fashionably late, of course…but not before all the hor d’ oeuvres are gone… (he secretly likes the little hot dog ones…)
Phil is ready to go…in his hyperactive imagination, he is already seeing his presentation being the crowning moment of the day… the spotlight on him…a standing ovation from an adoring crowd…confetti blowing across the stage…
Let’s fade to black before this gets any worse…
Strangely enough, Dr. Frank is no-where to be found…no one is exactly sure where he is…Dr. Mollie mentions something about Frank having another commitment…and how Phil and the team will handle the presentation “just like we rehearsed…”
Too bad that Phil missed the review sessions for the presentation…He doesn’t care…his only concern at this point is that Dr. Frank won’t see him wow the crowd…
Dr. Mollie Kewl handles the welcoming remarks…She makes some casual comments and reviews the agenda for the day…she comes off as very relaxed and in control… just the right touch that investors would think the head of research for a major player in the industry would have……after all, she has watched Dr. Frank do this countless times, and comes off as smart, smooth, and charming…The low-cut dress under her lab coat doesn’t hurt, either…
Things are going well; it’s too early in the event for anyone to start asking any tough questions…that would be rude…
Next, Cassius King provides an “overview of the financial side of the business”…( that’s about all he can say, because there aren’t any actual financial results to be presented…that would require a product, and maybe even some sales…).  Cassius stumbles through an oft-repeated story with a lot of financial double-speak and phrases like “continuing expenses related to…” and “increasing our dependence on a leveraged debt ratio for liquidity…” 
Behind the mumbo-jumbo, the numbers reveal a mind-numbing burn rate…and not even the slightest hint of any sort of revenue…
It starts to get a little dicey here…
Hardly Firestein covers the pharm bio industry for an upstart tech review financial website…His column is called “Firestein Theatre” and he considers himself the “guardian of the angel investor”…when Hardly is around, Dr. Frank and Phil aren’t the only over-blown egos in the room…He has begun to be a bit of a buzz-kill at the last several presentations…he keeps asking pointed questions…and not getting any real answers…And lately, Hardly has been bashing Fun E Pharm (FEPh on the four letter exchange…) in his financial column for not turning up any results…financial or otherwise…
Hardly starts to warm up with a few questions regarding bringing products to market…not a topic that normally gets covered at these events…Dr. Frank normally kept the conversation away from specifics like product candidates, or approvals, or revenue…After he lets Cassius fumble around a bit, Hardly poses a few more pointed question… it appears he is getting ready to run over Cassius, back up, and run him over again…
Now it is getting downright uncomfortable…nobody ever asked these questions when Dr. Frank was around…Fun E Pharm has always been an industry darling, and there has never been anything but praise for the company and it’s performance…
As Hardly stops to take a breath, Phil stands up (like the player he thinks he is…) and announces that his “Keynote Address” (he can’t resist…) will “cover the issues Hardly has raised and more…so, please, hold your questions…”
This quiets Hardly for a moment, and the other investment media all take turns assuring themselves that, while these are all good questions, it is obvious that Fun E Pharm and Dr. Frank have a handle on the situation and that everyone’s investment is safe…the mainstream media are mostly of the opinion that Hardly is a bit unseemly for treating an industry favorite in such a tactless manner…you can almost hear them saying “it’s an Open Bar, for crying out loud…”
Fade to black…

For record purposes, any resemblance to actual people or circumstances is purely coincidental…

Feds issue subpoenas for records…

OK, let’s wrap this one up…this has gone on for much too long…
So Phil needs some material for his presentation…now entitled “Present Direction of Progress for Scientific Happening Initiative Teams”…courtesy of Dr. Frank.
He had gone to the Initiative Teams progress review meeting, but most of it went way over his head…He got some buzzwords out of it like “science…, labs…, research…, progress…” which is all Phil normally picks up anyway, the buzzwords, that is…
Oh, and Dr. Mollie Kewl wrapped up with some comment about “developing new ideas…”
Phil had nothing…and when Phil Theelyre had nothing…Phil Theelyre got going…or at least that what he was desperately trying to convince himself of…
He got going all right…right to the cafeteria…lunch was his strong suit…and when you’re in a tough corner, you have to play to your strengths…
When Phil sat down, he happened to sit with his back to a table of Fun E Pharm research team members, who seemed to be laughing and having a good time…
Phil overhead someone say the phrase” new ideas”… “progress”…and “scientific breakthrough”…This was the kind of stuff he needed for his presentation…His lunch forgotten, Phil leaned back and began to listen and absorb, like the sponge his is…
It all sounded great, if a little short on detail…which was perfect for Phil…
Fade to black…
After lunch, Phil was in the Men’s room using the facilities, and he overheard another conversation…again with a lot of laughing and discussion of about “progress” and “new ideas”
He overhears a scientist say “we could have a product for…blah, blah, blah…” and everybody laughs and agrees that would be a great idea.
Fade to black…
Phil is on his way back to his office to sit and rest his eyes…his other strength…and he happens to walk past on of the new “Interactive Magic Activity Center” areas… (lawsuit from certain west coast computer company to follow…).  Apparently, Fun E Pharm has all the latest facilities with all the current trends…”in order to maximize the interactive nature of our research focus efforts…” or at least that what was in the press release when they opened the facility…
Anyway, the same thing happens…scientists laughing about a discussion along the lines of “I’ve got a good one…We can develop a process to…blah, blah, blah…” and then everybody starts laughing again…
Fade to black…

A couple of days have gone by since Dr. Frank asked Phil to handle the Investor Relations meeting… and Phil is starting to wonder what will be involved in his presentation to Wall Street…
Tuesday morning, Dr. Mollie Kewl invites Phil to a meeting…”It’s our monthly Scientific Hotbed Initiative Team Review Meeting…We hold them monthly…and management gets a chance to review our Scientific Hotbed Initiative Teams progress …”  Mollie is trying to be helpful…”It should help get you up to speed for your presentation…”
“Yes, of course…” stammers Phil, “That will be a big help…I had been planning on attending…”
Actually, Phil had never heard of the meeting…but he couldn’t bring himself to admit that…and he couldn’t be sure that Mollie wasn’t just pulling his leg…could there really be a Scientific Hotbed Initiative Team Meeting?…and if so, what would get reviewed?…
Mollie conducts the meeting with all of the scientific personnel present.  Unfortunately, Dr. Frank was out of town somewhere…and when the rest of upper management didn’t bother to show up when they heard that Frank wasn’t going to be there…
After a couple of dozen extremely vague presentations, about some even more vague development projects, Dr. Mollie wraps up the meeting with a rah-rah speech in which she presents the normal spin…the science is interesting…they’re hopeful…milestones are being evaluated…technology is being studied…breakthroughs require a lot of hard work…
blah, blah, blah…We’ll see you all next meeting…Let’s get back to work…
The scientists all scatter back to their labs…after scarfing up all the doughnuts, of course…
After the meeting, Phil is spotted leaving the conference room…he looks a bit confused, he’s muttering to himself, and trying to look thru the 1,276 slides that made up the presentation…
People are starting to ask about his presentation…he has heard that the Board of Directors will be watching…he is starting to wonder what he has gotten himself into…
and his shirt collar is starting to feel a little tighter than normal…

The week before…  Dr Frank asks Phil to accept the position of Executive Director of Public Investor Market Issue Relations with a big speech about “being my right hand man, handling critical issues, working in a big office…and, of course, the big salary and bonus that goes with it…” 

Phil falls for the whole pitch, hard…he accepts on the spot… He doesn’t know how to do the job or even what is involved, but that has never stopped him before… 

“Great” says Dr. Frank, “See you at the Investor Relations meeting next Tuesday…”  Frank walks away… he’s got a tee time with another industry big shot, and doesn’t give the issue a second thought… 

Phil is drifting away into his imagination…finally…the big promotion…the impressive sounding title, the big office, the raise, the bonus, the red corvette convertible…the personal assistant… 

Let’s fade to black now before it gets worse…  Phil shows up at his first meeting in his new position…He hasn’t seen the salary increase yet, or the bonus, or the stock options, but he has been assured that it is all in the works… 

But Phil is ready, he’s got the Armani suit, the silk tie, the hand rubbed Italian loafers, and he had a manicure for the first time in his life…he even had his toupee cleaned…  The meeting is actually a pre-meeting regarding an Investor Relations presentation…Phil doesn’t really know anything about this subject, but he’s ready to fake it with the best of them… 

Dr. Frank has been handling the presentations for the last 8 years or so…but he is losing interest in it…the analysts keep asking questions about markets, and products, and progress, and all these other financial questions…  The biggest reason the meetings have lost their luster is there isn’t anything to report and he is running out of ways to spin the same old bullshit…and especially since a Wall Street Biotech Analyst named Hardly Firestein is catching on to him…Hardly has apparently made it his mission in life to be a major pain in the butt with his coverage…and he has taken to asking pointed questions at the press conferences… 

Dr Frank asks Phil to handle the Investor Relations presentation for him…  Phil’s ego makes him accept… Phil is thrilled with the prospect of waxing prolific in front of the media…in his imagination he sees throngs of people in a conference room hanging on his every word… being taken to lunch on someone else’s expense account… beautiful financial correspondents begging him for an exclusive interview… 

Let’s fade to black now before it gets worse… 

This week’s episode begins with the Epilogue…
Scene 1- Fade up from black…

The Fun E Pharm administration building is in total chaos…The hallways are filled with people in suits talking on their cell phones…The main conference room is filling up with laptops and briefcases…every wall has sprouted 18 or so cell phones chargers daisy-chained together at each receptacle…it looks like giant black spiders are crawling up the walls…There are so many people in line trying to buy raspberry muffin tops (with walnuts) and Diet Tab that the employees can’t get into the Cafeteria…Lou Da’ Cris rushes into Del Lusional’s office…“Where did all those trailers come from???”…asks Lou…”Did we order those?”“That’s funny, the parking lot is full” says Del, who is staring out the window, “Don’t see that too often…””and there’s an 18 wheeler backing up to the loading dock”…blurts Lou…” We won’t be able to ship our latest batch of sample product samples…”Lou and Del rush out into the corridor…
Scene 2- outside the main conference room, there are lot’s of people walking around looking busy…
In their rush down the corridor, Lou and Del almost knock down Dr. Frank…
Dr. Frank N. Stein Chairman, CEO, and all-around good guy is making a rare appearance, but he seems quite upset, rather than his normal ‘I’m in complete control, even if I can’t remember anybody’s name’ image he so carefully portrays…
“Who are all these people?… what are they doing here?…how come they are all dressed alike?…and how come they keep handing me these envelopes???!!!…
Just then, a guy in a suit walks up and hands Dr. Frank a thick envelope, and says “We’ll be taking a look at these also…”
“Where’s Theelyre?…(he’s shouting now)…Has anybody seen Theelyre?…”
Everybody is busy ducking for cover, but since it’s Dr. Frank asking, they at least offer some feedback as cover as they squirrel off to their cubicles…
“He mentioned something about Safe Harbor…” somebody says
“I didn’t know he was going on a trip” replies someone else…
Lou and Del are stuck dead center in Dr. Frank’s sights…
“Safe Harbor…where’s that?” asks Del…
“I think it’s off the coast of Antigua”, Lou mumbles…
“Well, find him, Now!!!…Frank screams…
Lou and Del back away as Dr. Frank is losing it…
Fade to black…

Let’s meet our latest hero…Stewart (don’t call me Stu…) Piddity…
 

Stu has just flown in, fresh off his latest assignment over an ocean somewhere…and he is going to show everybody how he is going to manage the Supply of Management Chains…too bad he can’t manage anything else…Stu has an accent, a snotty attitude, and a passport.  His has the impression that only twelve people in the whole world have traveled on business, and he expects to be treated like the true star that he his, because he flew on Bulgarian Air Transport to some god-forsaken hole last year for an overseas project… but that’s another story…
 

Also, as Stu likes to remind you, he is the Senior Director/ Managing Vice President…
 

The action starts when Stu attends his first project meeting…imagine a crowded conference room, where the 57^th weekly project meeting is underway…
 

let’s see what happens…
 

Byersee Morse is trying to complete the procurement of a new process skid…
He is trying to get someone to cover the FAT for the skid, but can’t get anyone to agree to go…He is trying to avoid sending Bob Andweave to the FAT because last time Bob went near a vendor’s shop, he tried to have all the raw material validated against the Law of Gravity and all of the stainless steel pipe and fitting wound up with dings and dents before they managed to get him back on the airplane…but that’s also another story…
 

Anyway, Byersee is trying to get Del or Lou to go…and unfortunately, he mentions this at a meeting that Stu was attending…
 

Stu leaps into action…”I would like to review that PO…We need to comply with out new global policies regarding conforming to procedures and policies…”
 

Byersee is just trying to get the order placed and wrapped up… Fine”, he says…”I’ll e-mail the entire file to you…”  He knows this is something like 257 megs worth of paperwork…He figures it will buy him 2 weeks before Stu even gets it all printed out…
 

Stu is still babbling on…”We are currently negotiating a “Global Alliance Pricing Agreement” with all our current vendors…I’ll let you know if I have any questions”…Stu’s idea of alliance pricing is something along the lines of ”I might buy something from you next year, so you should give this one to me for free…”
 

Byersee has 12 other packages that are behind schedule because the engineering and design work is 27 months behind schedule…so he is glad to get something off his plate…
 

you can’t afford it…

We were discussing a new project the other day…a retro-fit required to address on-going production issues…sounds typical right?  the interesting part was the background…

In order to increase production capacity, the first train was “duplicated”…except for a couple of changes…most likely caused when someone suggested some “Value Engineering” ideas…a change to the pipe spec on a feed line, and a reduction in the physical size of the unit being driven by pipe slope…considered individually, both ideas sound like they could be justified…

let’s look at the impact, with some hypothetical numbers….yours may vary…

Original cost savings……….                                          ($100,000)

Original Engineering costs to review cost savings………..  $20,000

New retrofit project costs………                                   $2,500,000

New engineering fee……….                                            $250,000

Production losses (over 5 years)……….                        $2,500,000

Total Savings……..                                                         Priceless

No one wants to actually look at situations like this, it would be political suicide on the operations side…

The lesson?…beware of false economies…

It was getting to that time of the project…you know when everybody is trying to avoid discussing the validation plan, but they just can’t seem to hide from it any more…

Bob was not aware that Del Lusional, the Project Manager, was going to ask for a presentation about Validation and the strategy for the project…Had Bob been aware that he would be asked to answer a question, let alone make a presentation, he would never have shown up for the meeting.

Anyway, Del starts the meeting by informing the project team that Bob Andweave will be presenting his ideas on validation and the project strategy…let’s pick up the action as Bob walks in to the meeting late…

“Bob, glad you’re here” says Del…”We were just getting ready for your presentation…”

Bob falls into his chair…he wasn’t listening because he was too busy arranging his snacks for the meeting…(Bob never does anything at the meetings, so he needs a distraction)

“Presentation?!” Bob stammers…”What presentation?…I didn’t know we were having a presentation today!!!…”

“Not having one…Giving one…” Del is closing in for the kill once he remembers that he forgot to tell Bob about his request that a presentation be prepared to explain how the project would be validated…

“How about you get started? Del asks…”After your presentation, we need to review the budget for the complete Validation effort, including Commissioning, Qualification, Quality Plan, Validation Master Plan and protocols and process validation…”

Del has just used every buzzword he knew about Validation in a single sentence…

At this point, Bob has broken out into a cold sweat…His strategy to date for the project was to hire a contract employee to do the work before anyone realized he didn’t know all that much, or anything for that matter, about what it would take to validate a project…no time to let on now…

“Validation is a tricky issue…”Bob starts to stall…”with lot’s of complexities that everyday people like yourselves may not understand…”

“That’s OK, Bob” Del suggests, “we have you to explain the whole issue to us…in fact, why don’t you take this entire meeting and explain what validation is, why it’s important, and how we are going to approach it on our project?”…Del doesn’t want to have to admit that he doesn’t really know what validation is and he is just glad he can get someone else on the spot…(Del likes watching people squirm…)

Bob is working up to a full panic now, as the entire room is waiting for him to begin…

“Validation is like…like…like an…” Bob is stammering, it’s becoming obvious he doesn’y know where he’s going with this…He grabs at his snack, which happens to be an apple today…the inspiration strikes…

“like peeling an apple!!!” Having blurted this out, Bob stops for a quick bite of his apple, for emphasis…Unfortunately, this brief break allows the inane questions to start…

“like peeling an apple? or biting an apple?”…”A long skinny peel? or just chunky ones?…”

Lou DaCris is desperate to look like he knows what he is talking about, and weighs in with his two cents…”I was at an ISPE presentation the other day and the global director of BioPharm Validation from GSK was there…and he seemed like a real smart, knowledgeable guy with a good understanding of these issues, and he said he thinks validation is like an onion…”

“Or an onion…an onion would be good…” Bob agrees…

At that moment, in walks a Senior Project Manager…accompanied by a Junior Vice President…Del leaps to his feet to show he is in control of the meeting and explains that Bob was just comparing validation to fruit, or maybe vegetables…

The Senior Project Manager blurts out something along the lines of, “I heard that and I think we should implement that strategy on this project…

Bob Andweave plays right along…”Yes sir, I was just reviewing how our strategy would employ that very strategy…We will put that in our Validation Master Plan…”

Not to be outdone, the Junior Vice President adds ” I thought I heard that Validation was like a banana peel, be careful you don’t slip up on it…

Bob thinks the JVP went for the joke and laughs…unfortunately everybody just stares at him when they all realize Mister Junior Vice president was serious…

Bob then reveals his fatal flaw…he will always agrees with the most senior person in the room at the time…no matter how many about-face manuevers that takes…

“Yes, sir, the banana strategy…We’ll issue an update to the VMP to document that approach…

The Senior Management bustles out of the room…obviously they have too many big important issues to discuss to be bothered watching the little people work…that plus they don’t really know anything about validation beyond the fact that it seems to cost a lot at their company and it seems to take along time too…

Bob Andweave collapses into a sweat-soaked puddle while muttering about the VMP updates…

Del adjourns the meeting…He is proud he managed to get somebody else under the microscope…He starts looking foward to next week, and starts trying to figure out who he can catch next…

No one even bothers to think about the implications of project strategy being based on a fruit…

Another week off the project schedule, another week at an amazing burn rate…

Another perfect day, back at the Fun E Pharm…

The engineering crew- Del Lusional and Lou Da’ Cris 

QA Guy- Bob Andweave 

Procurement Department- Byersree Morse 

Equipment Supplier- Laydas Usual 

Marketing Salesman- Phil Theelyre 

Financial Guy- Cassius King

Contract Engineer- Kelly Services 

Consultant-  Terry Ratso 

Consultant- Wayne ScottValidation- Edie Itt 

The Contractor- Joe “Putz” Putinskistanovichowitz 

Project Scheduler- Connie Venient 

Foreman- Bobby Dahpiper 

Other miscreants and hangers-on who appear out of nowhere as needed to fill out the story line…just like in the real shows 

the blond bombshell/ love interest- 

Fun E Pharm’s head of continuing research… 

spends half her days attending conferences functioning as Dr. Frank N. Stein’s unofficial public relations crisis manager…she deflects any technical questions her colleagues may ask Frank and her looks keep the investors at bay…  

Back at the lab she spends the rest of her time trying to re-create the results of what she thinks is the most dramatic breakthrough in the history of pharmaceutical research…if only Frank could remember what it was… 

uses her science background to wind Frank around her little finger… 

The company founder- Dr. Franklin (Frank) Nunez Stein…

a grey-haired senior scientist turned CEO…well-respected in the industry, although no one is quite sure why… Frank thought he may have invented something in his garage a long, long time ago, and got $800 million dollars in funding from a confused angel investor who thought Frank had re-invented the internet… 

Frank doesn’t remember what he was working on (specifically) and never wrote the exact process down, but he gives great presentations… He spends his days making introductions at various conferences, moderating panel discussions, and playing golf with Wall Street Analysts and SEC investigators…who, obviously, haven’t caught on yet that Fun E Pharm doesn’t have a product, or even the possibility of developing one…but Frank is fine as long as the funding holds out… 

Frank hasn’t seen the inside of a lab in 17 years… 

Frank doesn’t like his middle name, and so uses his initial…   

Cleaning Protocols…

14/06/2007 - Just over a week after Roche was forced to initiate a Europe-wide recall of HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com considers the contamination case and the pharmaceutical cleaning process that was blamed for the incident.

The recall was prompted after reports from patients that their medication had a strange odour;  six patients from three different countries made the complaint within a week or so of each other, with two experiencing nausea after taking their medication.Following investigations by Viracept’s manufacturer Roche, samples of the tablets were found to contain abnormally high levels of ethyl mesylate, a harmful genotoxic substance.  On discovering the contamination, the company initiated a recall of all Viracept products manufactured by Roche across the whole of Europe.

The contamination was tracked down to a manufacturing plant in Basel, Switzerland, where a reaction between the drug’s active ingredient, nelfinavir, and chemicals used as part of cleaning processes at the site were blamed for the toxic substance found in the tainted drugs.

Ethanol present in the cleaning products is thought to have reacted with the API to form the harmful molecule, according to Roche’s investigations.

“The contaminant is actually usually present at very low levels in the drug, the upper threshold in the manufacturing process is around three parts per million,” Dr Herath, associate head of medical affairs in virology and transplants at Roche UK explained to in-PharmaTechnologist.com.

“However, as part of the maintenance programme at the site there may have been a cleaning error which resulted in more ethanol being present, and therefore higher levels of the molecule.”

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