GMP Compliance Basis Blog

Caraco’s Detroit plant gets quality warning

November 4th, 2008

read a 483 letter sometime…they are very informative…

Caraco Pharmaceutical Laboratories, in which India’s Sun Pharmaceuticals holds a 76 per cent stake, has joined the list of generics manufacturers issued with an FDA warning on quality control issues.

The warning letter, which was sent on October 31, blocks the approval of any pending abbreviated new drug applications (ANDAs) submitted by Caraco. The document relates to a US Food and Drug Administration (FDA) inspection of the firm’s facility in Detroit in May.

The following month, the FDA issued Caraco with a Form 483 detailing a list of quality observations that it needed to address. While the firm said that it had moved to correct all the shortcomings within 15 days, the FDA’s latest warning lists several “repeat observations” suggesting that Caraco still has work to do.

Although the October 31 letter has not been published in full, Caraco’s November 3 Form 8-K filing with the Securities and Exchange Commission (SEC) listed “the inadequate and untimely investigation by our quality control unit of certain incidents” among the problems that the agency considers are unresolved.

Earlier this year Caraco faced its first manufacturing setback when it was forced to withdraw several batches of its version of the generic diabetes drug metformin after it emerged that some of the tablets did not meet with approved specifications.

In an interview with India’s Business Standard, a Sun Pharmaceuticals spokesperson claimed that the FDA’s latest warning would not have a major impact on its US revenues, explaining that only 19 of its 96 pending ANDAs had been filed by Caraco.

However, given the difficulties already encountered, coupled with the fact that US generic sales represent about 40 per cent of its annual turnover, Sun is likely to seek a quick resolution in an effort to maintain Caraco’s position in the country’s booming non-branded drug market.

Caraco’s share price fell 68 cents, or 6.7 per cent, to $9.49 in morning trading on the New York Stock Exchange on the day of the announcement.

link to full article

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FDA awards contract for QbD research

November 3rd, 2008

The FDA has awarded a $1.19m contract for the development of quality by design (QbD) guidance for pharmaceutical manufacturers.

Under the contract the National Institute for Pharmaceutical Technology and Education (NIPTE) will develop design specifications.

NIPTE is a nonprofit consortium of 11 pharmaceutical engineering universities, including Purdue that will receive $300,000 to utilise its expertise in pharmacy, engineering and biological sciences to develop guidance.

Alan Rebar, senior associate vice president for research at Purdue, said: “With this FDA funding, Purdue will collaborate with other strong universities to develop this emerging area where we can focus on improving the science of drug development itself.

“This team also will study how to make the drug-manufacturing process more modern, helping improve efficiencies and the effectiveness of the pharmaceutical industry.”

Research by the consortium will start this year and is predicted to finish in September 2010, after which the information gained will be made public.

By the end of the contract the US Food and Drug Administration (FDA) is hoping to have furthered development its QbD initiative, which aims to take a more scientific approach to pharmaceutical development and manufacture.

link to full article

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Sugar Coater

October 15th, 2008

Scene 1 Lou Da’ Cris was on the phone…talking really fast…”Are you sure that’s the biggest one you make?…the other vendor said they might be able to make a bigger one…” Lou’s desk is covered with piles of paper…and on his computer screen is a document titled “Bid Tabulation and Technical Analysis”…it’s mostly blank… Lou has several documents in his hand, but it doesn’t look like he is reading them…His eyes are shut tight…and he’s grimacing…”I have to find the biggest one I can…” Del Lusional comes into Frank’s office…”What are all of these procedures for?…What are User requirements?…I’ve never even heard of a Traceability Matrix!!!…” Lou is grabbing for a bottle of Ibuprofen…”But I just want to place an order…why do I need to tell you what I want?…OK, I’ll call back this afternoon…” Lou hangs up the phone and looks at Del…”What we going to do…they won’t take my order…He said something about “not after last time…” Del looks just as panicked “What are we gong to tell Frank? What are Lou and Del looking for?…and why is it so important? They’re looking for a “sugar coater”… And it’s important because Dr. Frank personally asked for it…. Fade to Black… Scene 2 Dr. Frank was making a tour of a lab with his group of senior staffers following him around… In one lab a junior scientist is developing a new method for coating tablets…He tries to explain the new ideas he is using to develop and test the various formulations… Since this would require paying attention, Frank mind starts to wander…He spots something shiny sitting on the lab bench. Frank interrupts the scientist…”And what is this device used for?”, he asks. “That’s our test coater, we are using to test the various sugar formulations and the coating process” “I guess that makes it your Sugar-Coater?” Frank jokes…the senior staff all laughs, as it was the funniest joke they ever heard…Frank continues right along (the presentation from the scientist now totally forgotten…) Dr Frank was overheard saying he “could really use one of those” and that “he needed it in time for his next shareholders/ board of directors meeting” and one of his sycophant senior staff members agrees…”Great idea, Frank…” to which Frank replies…”Only it would need to be bigger…, to handle the load we’re going to throw in it…”

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FDA publishes final rule on cGMP amendments

September 11th, 2008

The US Food and Drug Administration (FDA) has published its latest amendments to current good manufacturing practice (cGMP) regulations.

Changes to the regulations were initiated after the FDA received “significant adverse comments” in response to the proposals that it published in December 2007.

The report states: “We strive to give manufacturers latitude to determine how to achieve the level of control necessary for cGMP compliance, recognising that, in some instances, more direction from the FDA is necessary to provide a uniform standard to the entire industry, minimise the potential for harm, or achieve some other cGMP objective.

“We periodically reassess and revise the cGMP regulations to accommodate advances in technology and other scientific knowledge that further safeguard the drug manufacturing process and the public health.”

Reassessment of cGMP began in 1996 to ensure regulations were inline with industry practice and incorporated suitable elements of standards adhered to in the European Union.

However, owing to the FDA adopting an incremental approach to modifying its regulations the 1996 proposals were never finalised. The FDA’s latest amendments will be effective from December 8.

link to full article

link to FDA document for rule changes

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FDA warns Sandoz on unvalidated manufacturing

September 3rd, 2008

Begin with the End in Mind…

Don’t you love the people who state, after the fact, that they will fully comply to blah, blah, blah…

The FDA says that Sandoz, the generics arm of Swiss drug major Novartis, failed to validate manufacturing processes used to produce metoprolol succinate ER tablets at its plant in Wilson, North Carolina. In its letter to Sandoz CEO Bernhard Hampl the Food and Drug Administration (FDA) said that a March inspection of the facility had revealed significant deviations from good manufacturing practice (GMP) standards.

The agency said that Sandoz had used data from unrelated batches of the drug to validate required content uniformity and dissolution tests and added that it had failed to record tablet press speed and hardness results in production records.

The FDA also identified several documentation issues associated with the manufacture of 25 and 50mg dosages of the hypertension drug, which is a generic, extended-release version of AstraZeneca’s Toprol XL.

The FDA said that it is concerned “that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations.”

The agency suggested that Sandoz implement the Trackwise automated investigation management system that is already in place at many of the firm’s other manufacturing facilities.

link to full article

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A blog for GMP Tips…

July 16th, 2008

GMP Training and Implementation Tips

This appears to be a blog for a service provider..training in this case…

I don’t normally link directly to commercial sites or service providers, but you might find this interesting…

Posted in Blog of the Week | 1 Comment »

FEP in a book?…

July 9th, 2008

Check out this post from the Biotech Blog!!!…

Convert a 102 page screenplay into a book. The topic is the development of a biotechnology company. Looking for a creative non-fiction writer who can write a compelling story. The CEO is available for input and is actively interested in developing the book, but has very limited time availability.

I don’t have 102 pages written for the FEP series, but I’m close…I was all over it until I saw the “non-fiction” requirement…

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Site Updates

June 23rd, 2008

Coding errors have been corrected for the Information Flow Diagrams

Check out Engineering here and and Construction here

Validation Flow Diagram to follow shortly…

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Test Post

May 12th, 2008

I seem to be missing the last 18 months or so of my posts…they are still available from the links in the sidebars and from the archive links…what a pain…I will see what I can do to get this cleaned up…

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Endless Summer- Part 7

April 30th, 2008

Justsay Kno was bragging on her summer intern program. Dr Frank seems very interested in how the young students are doing…in particular how they seem to know what needs to get done, and what it takes to do it…

Dr. Frank asks Bob Andweave if he has been providing training for the summer interns…”Training?” Bob asks…”for who?”…He remembers who he is talking to, and instantly agrees with Dr. Frank. “Training is a great idea…we should start a training program…we have training …we do lot’s of training…” Bob finally stops, perhaps when he realizes he is starting to sound pretty desperate.

Justsay senses blood in the water…”We have a Summer Intern Hire Training Program…the kids are doing validation work…” I would have thought you knew about it…” Justsay just smiles, knowing that Bob is squirming in front of Dr. Frank.

“Validation?” Bob asks…”We outsouce our validation…we have consultants for that”

“Right” says Dr. Frank “I’ve been meaning to talk to you about the numbers you have in those budgets.”

Justsay moves in for the kill…”the summer intern program has been very affordable…and they’re getting good stuff done… I was reviewing they paperwork the other day”…(that last part was a lie of course, but Justsay couldn’t help herself…)

“We’ve received a lot of value form our consultants”, Bob protests…

“Let’s go review those numbers” says Frank…

Bob follows Frank and starts to sweat…

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Endless Summer- Part 6

April 29th, 2008

It turns out that Stewart (don’t call me Stu…) Piddity is in charge of the student intern program here at FEP…only he doesn’t seem to realize it…

The program shows up in his annual Tactics Planning Strategy Report…a very important document at FEP…Senior Management prepares reports religiously…(it’s just that nobody reads them…)

There is now a line item that appears on the budget page of Stu’s TPS Report under the title reading Student Hire Intern Team Development…

It seems to be about the same amount of money as last year…which means it gets automatically reallocated in his budget each following year…no one has asked Stu any questions about it…which is good because he wouldn’t have the foggiest idea how to get an answer on it… The up side is that the Summer Validation Crew is going to be able to come back next summer…

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Endless Summer- Part 5

April 27th, 2008

When Peter and his friends show up at FEP for the start of their “summer internship” nothing was in place…the HR Department didn’t even know that more people would be coming…Lou had never mentioned it to them…

Lou Da’Cris couldn’t even explain what they’re supposed to do…it has something to do with validating the new skid that FEP had installed last summer…but he seems a bit short on the details…”the manufacturing people can explain what they need”, Lou responds when Peter asked what they would be working on.

No one thinks to ask what has been happening in the 12 months from this summer to last…

Peter, however, is getting used to functioning in the “total chaos” environment that is typical at FEP…and he suggests they take a look around…Lou has long since managed to disappear.

They take a look at the equipment skid…it’s been sitting unused in a process suite. The contractor left a couple of months ago…the manufacturing people in the area are desperate to get the equipment up and running, but the Engineering Department has been holding then up.

Peter gathers the team and explains that they are most likely on their own…They decide to plunge in to the task at hand…they scope out what they’re going to do…and how they’re going to go about it…being the online generation, it doesn’t take to long before they find the JETT site, a well-known site about GMP Compliance, and some other information regarding validation, master plans, commissioning protocols and execution of validation procedures…

The students decide to each grab a part of the project and start learning what will be involved

Peter looks in to Validation strategies and the Master Plan document…
Jennifer finds some draft IQ protocols in the Vendor documentation… there are some commissioning documents that the Contractor who installed the skid left behind…
Dave gathers the documentation used by the Procurement Department to purchase the skid…
Steve talks to some of the people in the manufacturing group who are waiting for the equipment to be validated to find out what the skid is actually supposed to do…

After their first week, the Summer Validation Crew, as they have begun to call themselves has their first status meeting…

Dave outlines how the machine is supposed to operate
Jennifer has walked down the utility systems and outlines what needs to be done
Steve has called the skid vendor and gotten some recommendations for typical start-up procedures and testing.

Peter outlines requires for GMP documentation and execution of protocols.

They wind up performing a complete IQ/ OQ for a new process skid…and have the manufacturing personnel ready to undertake the PQ while they go back to school for their Fall semester and football season…

Once again, they submit copies of their paperwork to the Engineering Department, write up their final reports for their internship, and count up the money they made.

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CPR Rankings- Part 1

April 11th, 2008

CPR Rankings

“Have you seen it yet?…it’s hysterical…”

The buzz was filling the halls at FEP…Well, among some of the staff anyway…

Dr. Mollie Kewl was blazing down the hallway on her way to another of her endless series of meetings…She noticed several groups of people in the hallways talking and laughing…When she walked by she overheard some of the chatter…

“She’s a six…” and then lots of giggling…it was kind of like high school all over again.

Mollie was busy and didn’t really take much notice…

In the Hallway

A similar scene was repeating itself throughout the FEP HQ Building

“He’s a three…down from four…”

and the laughter would start…

“I can see why” someone else exclaims…

“Where you at that last meeting? What a joke!”

“Yeah, it was just the same old, same old”

“nothing but bullshit excuses and blowing smoke”

“Do they actually think anybody at all is buying it?”

and the laughing starts again…

In the Cafeteria

The best was the scene in the Cafeteria…Phil Thelyre was taking his tray to his normal table where the “senior managment” all sat around sucking up to Dr. Frank…(the “Psychophant Suck-Up Table” or PSUT, for short) crowds of people behind him were falling over laughing as he walked by…trays were flying…people were rolling on the floor and falling out of their chairs…

“What’s all the fuss?” Dr Frank wants to know. “Did we announce a new employee excercise program?”

“Haven’t you seen it?!!!…the new CPR Rankings just got published!!!”

“Phil’s latest score is listed as “the square root of negative one!!!…”

“the CPR Rankings?…never heard of it…what is it, some sort of industry metric?”

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Endless Summer- Part 4

March 22nd, 2008

Lou asks Peter if he can come back to work over the summer break…it’s more of Lou’s usual story…”it’s just some quick validation stuff…just coordinate with the vendor…”

Lou continues to desperately try to avoid having anyone find out he can’t the work done himself…

Except this time he happens to mention that Peter should try to find some friends who could “come along and help out…we’ll have it all set up when you get here”…

Now the ball is definitely rolling downhill…and starting to pick up some momentum…

Summer rolls around and Peter and his crew show up at FEP…over spring break, he talked 2 or 3 of his friends into signing up for the summer intern gig at FEP by promising them a relaxed work atmosphere and some easy money…

Only when they got there nothing was ready to go…

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The Endless Summer- Part 3

March 21st, 2008

Peter had left behind some pretty simple things for Lou Da’ Cris to follow up on…or so he thought…

Much to Peter’s surprise (and very little to our’s…) Lou seemed to be having problems tying up the loose ends…

At first it was a phone call or two…with a quick question…and Peter was glad to clarify something…soon it was more calls, the questions not so simple…Peter was still glad to help, but he was trying to concentrate on his school-work…

Peter was home from school one weekend…and stopped by to see how everyone at FEP was doing…just a quick social visit…until Lou spotted him in the hallway…

“Peter!, I heard you were!!!…Do you have a few minutes?”…

Peter was beginning to figure out what Lou meant by “a few minutes” or “a few questions”…it usually meant that Peter would wind up doing Lou’s job for him…

The only thing Peter couldn’t figure out was whether Lou was lazy or stupid…

It winds up that Lou asks Peter to come back and work over the winter break between semesters…”It will just be some basic validation questions”’ Lou says…”just coordinate with the vendor”… The ball has started to roll down the hill…

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The Endless Summer- Part 2

March 17th, 2008

Let’s go back to the beginning of the story…
Peter was finishing up his second year in college and he wanted to get a summer internship…he wanted something cool…something that would look good on his resume…something that paid…
Peter wrote well, and prepared a good package describing his interests and qualifications and inquiring as to summer positions. He spread it around through contacts he made with his instructors. It took a while to get responses, but he had several options for the summer…
He wound up at FEP…he didn’t realize what he was getting himself in for…
HR jumps in…
The HR group at FEP hadn’t been doing much lately, and needed something to report at the monthly management meeting. One of the recruiters was reviewing Peter’s resume when the head of the HR Department, Justsay Kno, walked by her cubicle.
“Anything on our new Senior Director of Vice Presidents?”, asked Justsay…FEP was recruiting another vice president that month…something they never seemed to get tired of…The HR group at FEP hadn’t been doing much lately, and needed something to report at the monthly management meeting. One of the recruiters was reviewing Peter’s resume when the head of the HR Department, Justsay Kno, walked by her cubicle. “Anything on our new Senior Director of Vice Presidents?”, asked Justsay…FEP was recruiting another vice president that month…something they never seemed to get tired of…
“No…” replied the recruiter…”just some college kid looking for and internship”…
Justsay raced off to her management meeting and was getting grilled on progress on monthly hiring metrics when, in an act of desperation, she blurted out that she had been reviewing a college internship program and that that had kept her from making much progress on hiring another executive type…

Actually, she had spent a grand total of 27 seconds on the topic…but let’s not quibble…
Dr. Frank said something along the lines of it being a good idea to get some new blood in the company, and indicated that he thought a summer student program might be a good idea….
Off went Justsay, with a new mission in life…
Peter reports for work…
Nobody was really expecting Peter when he reported to his first day at FEP… nobody knew about the program since Justsay forgot to mention it…Nobody was really expecting Peter when he reported to his first day at FEP… nobody knew about the program since Justsay forgot to mention it…
He was quite excited, and didn’t really notice that he was being bounced from department to department…
Most of the department heads were pretty slick, and they managed to move Peter along until he wound up standing outside the cubicle bullpen of the engineering group.
Del Lusional (Head of Engineering) was busy making up excuses for missing a meeting and wasn’t there when Peter arrived…the HR rep told Peter to find a cube and settle in…

the peg had found his hole…

by the time Del figured out he had a new staff member, Peter had been there a week or two…
The moment of truth…
By this time, Peter has figured out that the engineering group was just winging it…even a college kid could smell the fear exuded by the engineering group who were basically all terrified that someone might find out they had no idea what they were doing…but as long as they kept Del confused, they were OK… By this time, Peter has figured out that the engineering group was just winging it…even a college kid could smell the fear exuded by the engineering group who were basically all terrified that someone might find out they had no idea what they were doing…but as long as they kept Del confused, they were OK…
One day, Peter stops by Lou’s office on the possibility that there might be some actual to get done…Peter was getting bored…Lou Da’ Cris was busy charting his way to the top of the company and didn’t have much time for Peter…
In a moment of serendipity, Lou hands a box of binders to Peter and asks him to file them…
Being curious and not having anything else to do Peter skimmed through the manuals…
they appeared to have something to do with some new process equipment…Peter found the information interesting and quickly began to read more…the binder contained Turn-over information for a new process skid…it was, it turned out, a good package from a reputable company…lot’s of good information…flow diagrams, P+IDs, equipment lists, layout drawings, control diagram, the whole nine yards…
Peter was fascinated…
As he flipped back to the beginning of the binder he noticed some paperwork contained in the front section of the binder…cover letters addressed to FEP’s engineering group… they were address to Lou Da’ Cris, and they outlined a tale of woe and remorse…
To Peter’s surprise, the vendors were suggesting validation steps be taken for the equipment, but had not managed to get a response from the FEP engineering team….the equipment was installed…the supplier’s contract called for complete validation services…and they were trying to finish up the project…
Peter stops by Lou’s office and asks if he can call the vendor…Lou isn’t even listening…he nods his head and reminds Peter to invite him to any meeting that is going to have lunch served…particularly if the vendor is paying…
Peter finds his way…
Peter needs to write a paper about his internship in order to get credit for a summer course, and he hasn’t seen or done anything that he even remotely use…these vendor documents might be just the ticket…Peter needs to write a paper about his internship in order to get credit for a summer course, and he hasn’t seen or done anything that he even remotely use…these vendor documents might be just the ticket…
He decides to take the bull by the horns…a couple of phone calls quickly becomes a couple of meetings…
The vendor is thrilled to have someone actually respond to their requests for information…and they quickly adopt Peter as their sole point of contact with FEP for the validation effort they need to perform…In another stroke of luck, the local rep for the vendor takes a liking to Peter…When he finds him to be a quick study, but lacking some experience, the rep takes Peter under his wing and begins to explain the mysteries of the world of validation to him…
By summer’s end, Peter looks like a duck in water…and he has quickly become the resident expert at FEP…with the help of the vendor, he wraps up the loose ends for the validation effort for the new process skid, files the documentation with Lou, and writes his paper…He collects his credits, and counts up all the cash he earned…and heads back to school…
FEP fades from Peter’s memory, as he quickly gets caught up in the rush of another school year…
Oddly enough, he gets occasional phone calls from Lou asking these really simple questions about some of the work he did over the summer…and he happens to mention it to his current professor…
Peter’s instructor tells him to stay in touch with FEP…it always helps to know people in the industry…Peter doesn’t give it much thought, but sends off an e-mail to the HR and Engineering departments thanking them for his internship…Without really thinking about it, Peter includes some mumbo-jumbo about “future opportunities to gain additional experience with FEP”…
Little does Peter know that FEP will play a major role in shaping his future…

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ASTM E 2500-07

March 15th, 2008

You’ve got another document to buy/ read!!!…

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

Scope- (from the ASTM website)

1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.

1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.

1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.

1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation.

1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.

This standard does not address employee health and safety, environmental, or other non-GxP regulations. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

There’s a good article covering the basics in the Nov/ Dec 2007 Edition of ISPE’s Pharmaceutical Engineering- Volume 27, Number 6

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The Endless Summer (at FEP)…

March 12th, 2008

It was a special time…that summer that never seemed to end…

maybe you remember what it was like…

It was a time of great change, cultural upheaval, people questioning “the system”…and new ground was being broken…new discoveries were being made… people learning things they never thought they would get a chance to do…experiences that could form the memories of a lifetime…

Some of us did not get to experience that time…you may not have been in the right age group…maybe it was a little before your time…maybe it was a little after…

Think back…Let’s try to remember what it was like…

The first thing you notice is the music…it was loud, and very different from what was being heard on the “the Pop music” scene…

The next thing you might notice was the lights…lots of flashing lights…a lot of different colors…flashing seemingly at random…if you try to concentrate on them too hard you might get a headache…eventually they seem to kind of blend in with the music…

Then there was the hair…you might find yourself looking at the various people in the Process Room and thinking, “What kind of hairstyle is that?…Is that really their hair?!!!…How do they get that inside their gown?…”

Next you might notice the flowers…and the other stickers…symbols of an alternative culture…silent protests against a complacent society of apathetic people just going through the motions, unthinking, never questioning the activities deemed important by an uncaring management…they cover most every surface of the process equipment in the room…

Gowning?…Process Room?…Equipment?…What is going on here? Who are these people and what are they doing in a pharmaceutical manufacturing facility? This is an outrage!!!…or is it?…

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Invasion of the Document Snatchers- the story begins to unravel…

February 25th, 2008

There are two meetings going on at FEP…

Big, important, fancy meetings… with rooms full of highly paid people… where intense discussions are taking place… discussions which will impact the future of the company…

Unfortunately, the conversations sound like two very different sides of the same story…

Dr. Frank dances with the investors

Dr. Frank is meeting with the investors regarding the next big round of financing…everybody wants to be a part of the “next big thing” and they have brought bags of money to prove it…
Frank is wandering the meeting room like a beautiful woman filling her card at a dance full of ugly old men…investors are lining up to get a shot at giving their pitch…only to be told that there is “someone else” who might garner Frank’s attention…

It’s a reverse feeding frenzy…

The highlight of the meeting is the visiting Chinese delegation… they tell Dr. Frank that they want to buy a symbol of “the next great American Business Juggernaut”…or, at least that’s what the translators think they are saying…
(Remember when the Japanese bought Rockefeller Center in the 80s… they’re probably just trying to keep up)…

Frank is collecting investor by the million…

Things are looking good…

Dr. Mollie listens to the science

It’s another in a long line of dreary Statistically Highlighted Investigational Techniques Review Meeting…(They haven’t quite managed to get their oddly named review meetings together yet…but that will not stop them from trying…)
The various teams each present their current research projects and development issues…some of the work presented is quite good, and would be considered excellent progress at most any other company…(unfortunately, the rudderless approach that defines FEP’s research program makes any real progress almost impossible…)

Dr. Mollie is watching the various scientific teams give their presentations… and she is starting to get worried…

It’s all good stuff, but it doesn’t match the bill of goods that was sold to the investing public during Phil’s escapade… She hasn’t heard anything that even vaguely resembles the glistening promises of that fateful day…
Mollie is scheduled to provide a summary report of scientific progress to the investors gathered in the other room with Dr. Frank…

The pressure is on now…and things aren’t looking too good…

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FDA Forum Moderator

February 8th, 2008

FDA.com is looking for a Forum Moderator…

The contact e-mail is listed as jcuspilich@fda.com

If your not interested in moderating, at least check out the discussion forums

Posted in Qualification, Uncategorized | No Comments »

GMP Compliance Basis Blog

Caraco’s Detroit plant gets quality warning

Caraco Pharmaceutical Laboratories, in which India’s Sun Pharmaceuticals holds a 76 per cent stake, has joined the list of generics manufacturers issued with an FDA warning on quality control issues.

FDA awards contract for QbD research

The FDA has awarded a $1.19m contract for the development of quality by design (QbD) guidance for pharmaceutical manufacturers.

Sugar Coater

FDA publishes final rule on cGMP amendments

FDA warns Sandoz on unvalidated manufacturing

A blog for GMP Tips…

FEP in a book?…

Site Updates

Test Post

Endless Summer- Part 7

Endless Summer- Part 6

Endless Summer- Part 5

CPR Rankings- Part 1

Endless Summer- Part 4

The Endless Summer- Part 3

The Endless Summer- Part 2

ASTM E 2500-07

The Endless Summer (at FEP)…

Invasion of the Document Snatchers- the story begins to unravel…

FDA Forum Moderator

GMP Compliance Basis Blog

Fun E Pharm

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