By government mandate, the FDA is required to conduct regular cGMP inspections every year, at different manufacturing establishments that have association with FDA regulated companies.  Because pharmaceutical production and quality control is one of the most important functions of the FDA, the government has created Compliance Program Mandate 7346.832 requiring that regular cGMP inspections be carried out, by the strictest means necessary, in full compliance with cGMP standards and requirements. This includes pharmaceutical laboratories, or any other manufacturing area that is being used for in-process or finished product testing.

The cGMP inspection may be limited to specific issues regarding your pharmaceutical operation, or may encompass a complete evaluation of your laboratory’s total compliance with cGMP regulations.  Whatever the specific objective for your cGMP inspection is, it will be thoroughly explained to you in great detail, before the inspection has taken place.  At the minimum, each pharmaceutical quality control laboratory should receive a comprehensive GMP evaluation at least every 2 years as part of your statutory inspection guidelines.

These cGMP inspections may be specific to the methodology being used to test a new product, or a specific aspect of your operation. Or it could be a complete assessment of your entire laboratory’s compliance with cGMP regulations and guidelines.  Whatever your cGMP inspections may include, the most important thing your company can do is to be prepared. cGMP inspections can be some of the most difficult, and heavily scrutinized inspections by the FDA, and they are not to be taken lightly.  For your company to succeed in its cGMP inspection, it must be adequately prepared.

The best thing your company can do when making preparations for its cGMP inspection is to consult with an outside pharmaceutical consultancy firm, for the best preparation strategies when dealing with your cGMP inspection.  They will be ready to instruct you on the best inspection readiness strategies, as well all the cGMP guidelines and restrictions you should be aware of.  They will also help to train your staff, so that they are better suited to answer questions effectively during your cGMP inspection.  Adequate preparation cannot be delayed until the last minute when preparing for your cGMP inspection. Your company will need at least 6-12 months of preparatory planning.

It is important to remember that is it the cGMP inspectors job to approach the inspection with the specific job of making sure that your laboratory is achieving consistency and uniformity with all cGMP regulations, as well as being a safe working environment for employees.  With this in mind, your company will know exactly what to do, and what needs to be done, to sufficiently pass all cGMP regulations.  If your company doesn’t take all the preparatory steps necessary, is not ready for the inspection, and fails it, it could cost your company millions in lost product, and could hurt your company’s credibility in the long run.  To make sure this doesn’t happen to your company, preparing your staff as soon as possible, gives you your best chance for success.

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Successfully managing a cGMP inspection begins first with developing a clear cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection.  Because the FDA can arrive at your company without any prior notification, it is important that you thoroughly, and regularly train and prepare all personnel, so they will be ready to act if an unannounced inspection takes place.  But how do you thoroughly plan and prepare your company for a cGMP inspection audit, and what do you do if they show up one afternoon at your front door?

The FDA inspector must present some form of notice of inspection (FD-482), and should offer proper FDA credentials upon your company’s request.  If the FDA inspector cannot supply you with the proper credentials, then it is within your company’s legal right to not begin the investigation until the person can authenticate their FDA status.  Any persons accompanying the investigator should be able to provide proper identification as well, and also explain their purpose for requesting entry and authority to enter your premises.  Upon presentation of these formal documents, entry can not be refused as long as it’s under normal business hours.

Once the inspectors have been verified, your company representative shall notify a designated individual, who will then notify all the relevant managers and department heads and let them know that there is an FDA inspector on the premises.  Once you are ready to begin the FDA inspector will notify your company the exact purpose for the inspection, and roughly how long it will take for them to complete their audit.  You will want to supply the inspectors with an office room, or conference room, so that they can set up a base of operation, and review their records and files.

The inspection itself, usually involves a combination of physical plant inspection, as well as possibly document and record review.  This may also include any recent complaints, production records, and possibly storage and shipping records as well.  All employees should cooperate with the investigation in any way they can, while assuring that their conditions meet your proper code of conduct that you have set forth.  Your company representative must accompany the investigator at all times during his investigation, as well as keep detailed notes, including record of dates, times, areas inspected, questions or remarks from the investigator, and any observations made.

Your best chance of having a successful cGMP inspection, is to thoroughly prepare for it.  Even if the audit is unannounced, your company and personnel should know exactly what protocol to have, and a plan already in place.  The best way to prepare for a cGMP inspection is to first hire an outside pharmaceutical consultancy firm that can help your company to make the adequate preparations.  They will be able to thoroughly guide your company on the best course of action your company can take, and teach you how to properly put them in place.

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Until recently, standard treatment methods for serious bone loss due to bone fractures and bone disorders, have been limited at best.  Standard treatments for serious bone fractures would encompass basically two treatment options: either face amputation, or face long periods of disability.  While prosthetic implants, on the other hand, have proven equally as frustrating over recent years, and are proving more inefficient in the long term.  Because of these problems, something needed to be done, and at the Hebrew University of Jerusalem, researchers are claiming they have found the solution.  And the solution, surprisingly enough, is connected with using stem cells.

Until very recently, patients with severe bone loss trauma, or serious bone fractures had limited options when choosing a treatment regimen that would live up to their needs.  But researchers from Hebrew University have developed a new way of growing back bone fractures, through the use of cutting edge stem cell technology.  This stem cell technology uses stem cells isolated in the bone marrow, for the purpose of regenerating bone tissue in the patient.  Sounds a little far fetched, but this technology has already been used several times by doctors and researchers in the University Hospital in Jerusalem, with surprising results.  It actually worked.

In the last decade or so, there have been promising advances world-wide in stem cell technology, as well as biological therapy for the treatment of complex bone fractures and bone loss.  With more concentrated advancement of multi-potent stem cells in the last few years, stem cell technology is becoming or adaptable everyday in treating real life health issues.  Because of this differentiation between various stem cell types, scientists are able to isolate specific adult stem cells that in this case have the ability to repair injured tissue, such as bone, tendons, cartilage, and even the heart muscle.

This new stem cell technology, known as immuno-isolation, can work with almost any tissue in the body, and so far it has shown promising results.  This technology thus far is showing great progress in human studies, and it has already been shown to be successful in regenerating tissue such as bone, heart, and tendon, in a study on lab animals.  Because of these recent ground-breaking discoveries, scientists from all over the world are joining forces, so to speak, to establish a clinical grade protocol for the use and advancement of such immuno-isolated stem cell technology.

But before this technology is widely administered to the general public, experts in the pharmaceutical consulting industry are saying it could be decades before we start to see any real benefits from this science.  This is due to several reasons.  One is that MSC Stem Cell isolation technology is considerably lengthy, not to mention extremely expensive.  MSC isolation technology can also be possibly harmful to the quality of the stem cells, because of the long growth time required inside incubators.  Whatever the drawbacks may be, there is no doubt that emerging stem cell technology, like MSM isolation therapy, is at the very forefront of a technology that could realistically, and maybe indefinitely, change the way society looks at medicine forever.

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Ever since the Swine Flu scare of 2009, governments all over the world aren’t pulling any punches in the inevitability of a real pandemic event.  The potential public-health risk posed by a real pandemic event would be altogether catastrophic in many parts of the world, especially in third world countries.  The only hope for governments to stand any chance against a serious influenza outbreak would be to have a multitude of vaccines already available to the public, to fulfill their needs if the worst were to happen.

However, for governments all over the world to have the financing for all that this would entail, as well as be able to prepare for an ever-changing and evolving virus, would be pretty much impossible.  So what are the governments’ plans around the world for such an outbreak, but more importantly, are there any plans at all?

Governments around the world do have standing procedures to follow if an influenza outbreak, like the one of this magnitude, would break out.  Their standard procedural plans include trying to quarantine as many sick people as possible, and try as fast as they can to administer a working vaccine.  However, in pandemic cases like these, the new virus could spread so quickly that much of the population could be infected in a matter of weeks.  This is why it is so vital to your health care options to be able to have vaccines in place that can take on the viruses of the future.

Scientists all over the world are scrambling everyday to advance viral biology in such a way that pandemic outbreaks like these could be things of the past.  Scientists today are developing wide ranging viral technology that could help increase infection response vaccinations, if a large event were to break out.  Scientists hope in the next 20 years to have enough viral technology that in the case of any large viral outbreak, they would be ready for it.  But is this even a possibility concerning the wide variety of diseases and viruses that could break out at any time?  Some experts aren’t so sure.

Experts in the pharmaceutical industry don’t necessarily feel the same enthusiasm.  They know for a fact that for the process of any vaccine to be created at such a wide scale, it could take months to years in testing and production, especially at that magnitude.  Any pharmaceutical consulting firm will tell you, it’s just not a feasible plan.  The only hope for such an event would be for the pharmaceutical industry and governments around the world, to have an active and ready plan with vaccines already made and ready to be distributed.

The only problem with this is being able to have enough different varieties of vaccines available, to be able to have the right vaccine needed, already in stockpile.  This is, however, unlikely.  But with the latest breakthroughs in modern science, and a new attitude towards disease preparedness, governments and the public may have reason to be hopeful as we move into a new technological age.

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Although your company may prepare itself sufficiently, even going over and above the necessary steps in preparing for your FDA audit inspection, there is still a chance that your company may not pass the test.  So what then?  So what happens if all your pre-inspection preparation is all for nothing, and you failed your inspection anyway?  Well it doesn’t exactly mean that you’ll get thrown in jail, or have your company wiped off the books anytime soon, but it may cause serious problems to your company in the event of an inspection failure.  Here are some consequences your company might face if you fail your FDA Inspection.

One severe consequence of this is that the news will very likely become public, which could damage your reputation as a company.  This may result in a loss of consumer confidence, your stock prices could very well go down, and your business partners and investors may lose faith in your company.  This could result in millions of lost investment, sales, and value in your company.  The best thing your company can do when preparing for an FDA inspection is to hire an outside pharmaceutical consultancy firm that can help you fix any mistakes you might have had, and to fix all the paper work accordingly to prepare for your next inspection.

Another problem with failing an inspection is that it will only lead to more rigorous inspections down the line.  Any discrepancies you may have during the second or third time around will be much more closely scrutinized than it would have been during the first inspection.  They will also want to verify any new data you may have, including any revised procedures, and may even visit the clinical investigators working for you.  They will want to check, and double check all the company information and data registered by your clinical investigators very closely, and make sure there is no discrepancy in either report.  Failing an even more scrutinized inspection can further lead to more inspections, which won’t get any easier.

One problem you might face in the wake of more and more failed inspections is the possibility of being disbarred.  This means that the FDA can debar you from having any activity in the company, or any company, with a pending or approved NDA or ANDA.  This could not only put your individual career on the shelf for quite a period of time, but can hurt your company in further tests down the line.  In fact, before any company with a submitted NDA or ANDA try again in the testing process, they must verify that no debarred individuals took part in the testing, or it will automatically fail.

Another concern of failing too many inspections is the possibility that your company could be brought up on fraud.  If your application is being denied time and time again, and you’re failing each and every inspection, the FDA is within legal right to sue you for an attempt at fraud.  They then could invoke the Applications Integrity Policy, which will closely scrutinize every part of the company’s dealings including its own internal audits, clinical records, and where the money is going.  Your company could then be forced with a wrong acts, or fraud lawsuit and your company could be closed down permanently.

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Recent reports coming out of Europe and the United States are all showing that the pharmaceutical industry, at large, is taking tremendous steps into “Going Green”, so to speak.  Because of the recent economic decline, as well as market uncertainty, and overall economic uncertainty plaguing the Big Pharma industry, many pharmaceutical companies are doing whatever it takes to cut costs, and that includes looking for cheaper alternatives.  Recent studies indicate, that many large pharmaceutical companies such as Johnson and Johnson, and Pfizer, are taking drastic steps all across the board, to cut spending, and one of them is an adoption of green manufacturing, known as green chemistry.

With the pharmaceutical industry facing looming expiring patents of some of their biggest blockbuster drugs, as well as the proper candidates to replace them, uncertainty looms in the pharmaceutical industry.  Because of this economic uncertainty in the pharmaceutical industry, many companies are looking for ways to completely shift their agenda to a greener agenda, to further cut costs, and win better publicity for their company.  And as leading pharmaceutical companies are beginning to follow suit, it seems like everyday there is more and more pressure among everyone in the industry to look for new and innovative ways to go green.  And one of these ways that happens to be picking up steam is green chemistry.

Green chemistry is a sophisticated approach being taken by some in the pharmaceutical industry to not only cut costs, but be more environmentally responsible.  Green chemistry is a practice of using commonly used chemicals, with natural reagents, minimizing not only the energy use, but cutting costs down as well.  The natural solvents replace organic solvents with water, thus making it invariably cheaper to perform.  Pharmaceutical sales consultants, as well as others in the industry are noting that savings at lab scale alone could help any struggling company save money.  But when talking about green chemistry on a large manufacturing scale, the savings could be in the billions.

Many pharmaceutical consulting firms and large pharmaceutical companies, such as Pfizer, and Johnson and Johnson, are doing everything they can to bring green chemistry into the forefront.  Companies like these, and others in the pharmaceutical industry, are starting to put green projects way up on their priority lists.  Many have speculated over the years that going green is more expensive, and it just wasn’t practical in these economic times.  But recent studies are starting to show that not only is going green often the cheaper option, but may help companies survive longer as the nature of business changes in the 21st century.

A key aspect to green chemistry is minimizing or eliminating the use of all unnatural or hazardous chemicals.  Many companies such as Pfizer are finding innumerable ways to cut down on harmful chemicals by just creating cheaper, natural solvents in their place.  This is not only saving drug companies millions of dollars in development and distribution, but is potentially saving its consumers of potentially hazardous, cancer- causing chemicals, as well as sustaining an environmentally responsible attitude that hopefully will lead the way for other pharmaceutical and manufacturing companies for decades to come.

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Preparing your company for an FDA inspection is no easy task, but if you do all the adequate preparation necessary and know all the key points your company will be inspected on, your company has a much better chance of success.  Like it or not, if your business is involved in any way with the FDA, sooner or later, your company will face inspection.  If your company is not adequately prepared your company or its products can be seized, penalized, or even brought up on charges. Instead of running from this, or trying everything you can to avoid it, there are simple steps your company can take to be as ready as you can when a surprise FDA inspection comes your way.  Here is how.

One of the most important steps you can take when preparing for an FDA inspection, is to give your company enough time to prepare itself.  If your inspection is happening in a few weeks, then it will be almost impossible to prepare your company properly for the lengthy inspection.  Planning for an FDA inspection must take place over the long term, and a few weeks of half-hearted planning will just not suffice.  In order to prepare your company adequately you will need at least 6 months give or take, of research and planning to be able to be thoroughly prepared for the audit.

One of the preparatory steps you can take for an FDA audit is hiring a pharmaceutical consultancy firm that will run mock audits until your company is adequately prepared.  They will thoroughly test your facilities in such a way that you will better understand your strong points, as well as your areas of concern.  They can update you about any new rules or regulations that you may encounter in your FDA audit, as well as give your organization advice on the best way to operate your facilities.

Another thing you will want to do when preparing for your FDA inspection is to take some time and familiarize yourself with the FDA procedural list.  Knowing what kind of questions your FDA inspector will ask in advance and can be a great advantage to your company when preparing for the inspection.  Also, doing some preparation on the FDA inspection procedures will enable you to feel more confident when the inspection comes around, as well as give you an element of control over the situation.  Whatever type of questions may be asked, you’ll be ready for them.

Another smart thing to do is to have a trusted note taker alongside of you during the entire length of the inspection.  This is important if there should be any disputes arising during the inspection, or in case you would like to dispute something down the line.  Your note taker should also be one of the more knowledgeable employees in your company, one who could possibly assist you if questions arise.  If you prepare your company thoroughly, and if you know the inspectors’ procedures inside and out, then you have little to fear in your upcoming FDA inspection, and you should pass everything with no problems.

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The H1N1 flu virus, or better known to the public as the Swine Flu virus, swept across televisions sets all over the world, when in March of 2009 a swine flu frenzy took shape.  Airports closed down all over the world, and a fear of a new and apocalyptic super virus became a real concern to millions of people world-wide.  Although the “Super Virus” didn’t wreak havoc all over the world, like the news media claimed it would, it still affected millions of people world-wide, and was even life-threatening to some.  But what is the swine flu virus, and where did it come from? And is the miracle H1N1 swine flu vaccine really all that it has been made out to be.

The H1N1 virus is responsible for the dangerous flu strain that we know as the swine flu.  The H1N1 virus strikes quickly in infected patients, starting off with flu-like symptoms as well as respiratory problems.  However, what makes the H1N1 virus such a formidable opponent is that the influenza strain can quickly become more severe, and within hours you could be facing a very serious situation.  A person might start striking a very high fever, upwards to 103-104 degrees, and could suffer from dehydration or go into severe shock.  If your fever is spiking and you can’t explain why, it might be time to go in and see your doctor.

The Swine flu virus is also dangerous because it can affect your pets as well.  The H1N1 virus has been known to affect cats, dogs, pigs, turkeys, and even rabbits.  Now this is not altogether uncommon in influenza viruses, as many flu and cold viruses have successfully been passed to the animal kingdom before, such as people giving their dogs a cold or even a flu virus.  But what makes the swine flu virus so dangerous, is the rate at which this disease is being passed from pigs to humans.  This can be extra dangerous because during this transformation process between animals and humans, the virus can mutate and change it’s DNA into a different, more powerful flu strain altogether.

Some animal symptoms of H1N1 are very similar to a human’s symptoms such as coughing, sneezing, nasal discharge and heavy breathing.  As with humans, complications can occur after the onset of the H1N1 virus, and if your pet is not treated in time it can either pass the virus to you, or cause serious health problems to your pet, even death.  This is why it is important to take your pet into the veterinarian if it seems to have prolonged symptoms, as it could pass the virus to you, or become possibly fatal to your pet.

When dealing with the swine flu many doctors, as well as medical professionals and pharmaceutical consultants all agree: do not take any chances.  If you’re feeling a flu virus coming on, and your symptoms are getting worse, then don’t hesitate to go to the doctor and get checked out.  There are also prevalent swine flu vaccinations out there that can help you prevent getting the virus altogether.  Although the swine flu virus hasn’t been the global killer we were all lead to believe it was, it is still a very dangerous virus and should be respected as a formidable disease.

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With the announcement today of the pending retirement of Mickey Flynn, as President of  PA Bio the region is about to experience a significant change . Mickey has been a great advocate of the PA region’s biotechnology industry and Smart Consulting Group’s mission and we would like to acknowledge his contributions.

Congratulations and thank you on both counts and for your continued friendship and encouragement.

Pennsylvania Bio news release

MICKEY FLYNN TO STEP DOWN AS PRESIDENT OF PENNSYLVANIA BIO MID-YEAR, BOARD NAMES CHRIS MOLINEAUX HIS SUCCESSOR

Malvern, PA, February 2, 2010—The Board of Directors of Pennsylvania Bio announced today that Dennis M. “Mickey” Flynn will step down as president of the association on June 30, 2010, and named Christopher Molineaux, senior vice president of Pennsylvania Bio, as Flynn’s successor.

To facilitate a seamless leadership transition, Flynn will continue to serve the association for the remainder of 2010 as vice chairman of the Board of Directors and a member of the Executive Committee.  Molineaux will continue in his role as senior vice president for membership services and begin over the next five months to transition into broader operational responsibilities of the association.

Flynn is a founder of Pennsylvania Bio, the trade association for the bioscience industry in Pennsylvania, and served as a Board member and chairman before assuming the role of president of the association in November 2005. “Mickey Flynn has been a tireless advocate for our industry and an outstanding president of our association.  For more than 30 years, Mickey has been a leader in our community and most recently succeeded in making Pennsylvania Bio one of the largest and most effective trade associations in the country for our industry,” said Steven Nichtberger, M.D., Pennsylvania Bio chairman and president and CEO of Tengion, Inc.

Flynn has grown the organization to more than 375 members in his four years as president of the association, making Pennsylvania Bio one of the largest state-level trade associations for the bioscience industry in America.

“Through growth in programs and group purchasing opportunities for members, as well as extraordinary advocacy efforts in Harrisburg and Washington, DC, Mickey Flynn’s leadership at Pennsylvania Bio has had a tremendous impact on bioscience companies in the Commonwealth of Pennsylvania,” said Julie McHugh, vice chair of Pennsylvania Bio’s Board.  “We are fortunate to have someone of Chris Molineaux’s caliber and experience succeed Mickey as president of Pennsylvania Bio and are confident that he is the right person to lead our association to an even greater level of success in the new decade.”

Molineaux joined Pennsylvania Bio in September 2009 from Johnson & Johnson, where he most recently served as worldwide vice president of pharmaceutical communication & public affairs.  He began his Johnson & Johnson career as vice president of corporate communications at Centocor in Malvern. Molineaux brings to Pennsylvania Bio more than 18 years of experience in health care policy and advocacy, including industry and payor community expertise. He served as vice president of public affairs at the Pharmaceutical Research and Manufacturers Association (PhRMA), and for seven years prior to this, he worked with the Blue Cross and Blue Shield Association in roles of increasing responsibility in communications and policy. Molineaux also worked as a public affairs executive for both the federal Departments of Health and Human Services (HHS) and Agriculture.

“Throughout Pennsylvania, the biosciences are a cornerstone of our commonwealth’s economic future. The industry is responsible for more than 77,000 direct jobs and an economic impact in the tens of billions of dollars, making Pennsylvania a national leader in the development and sales of innovative products to patients in need.  I am proud to support the continued growth of the biosciences in our state and will work to ensure that Pennsylvania Bio continues to provide world-class services and advocacy to assist in the success of our member companies,” said Molineaux. “I look forward to expanding on Mickey’s wonderful legacy.”

“I am honored to have spent my career in an industry that is dedicated to improving the lives of people,” said Mickey Flynn.  “Serving as president of Pennsylvania Bio has in many ways been a wonderful capstone to my time in this industry. I am particularly proud to have worked with so many bioscience companies and dedicated professionals focused on providing new therapies for patients who suffer with health issues for which there is no help, but fortunately through medical advancements made by many of our member companies, there is now hope. Chris Molineaux has the experience and vision necessary to be an outstanding president of Pennsylvania Bio, and I look forward to working with him to ensure a successful transition.”