The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage.

These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells for Parkinson’s disease, and oligodendrocytes resulting from embryonic stem cells to heal spinal cord injuries.

The key to success is to detect the best mechanism to transfer these cells.  For example, cell-based therapy is employed to treat osteoarthritis of the knee, where the damage to cartilage and the subchondral bone produces less fibro cartilage repair than the mechanical properties of articular cartilage.  The majority of patients develop an acute degenerative joint disease, and over 250,000 knee replacements are done in a year.  In this case, injecting a suspension of autologous cultured chondrocytes into the problem area won’t work effectively because the cells have the tendency of forming fibro cartilage and of losing their round shape.  The best way to treat osteoarthritis of the knee is to embed the chondrocytes in the cartilaginous matrix that wears away just as the cartilage does.

If the chondrocytes are enveloped in gels, this permits the cells to maintain their rounded shape, and the properties of the gels can be controlled to let the tissue regenerate.  The mesh has to be small enough to hold up the cells, and open enough to get water and nutrients.  Equally, the gel structure has to disintegrate at the right rate so that the extracellular matrix that is secreted is not limited only to the area that surrounds each chondrocyte.

The cartilage tissue that is engineered can replicate the structural characteristics of native cartilage to such an extent that the cell orientation and the regenerated cartilage look like native cartilage.  The cells that are enveloped in this kind of matrix can migrate to and from the cartilage at the surface.

A vital matter brought up by cell-based therapy is how to make the most of the utility of cells delivered to an environment that is passive or tolerant, where there is context for the kind of cell required but in which very few biological signals are produced to support normal cell function.

In the end, bioengineers picture a material system in which the embedded cells emit a signal so that deeper cells form bone white cells close to the surface form cartilage.

Regenerative medicine anticipates several things:

-A rising impact of cell-based therapies in clinical medicine

-Methods that make it easy to regenerate skin, bone, cartilage, bladder, and trachea from bone marrow stem cells, and also the regeneration of blood vessels and heart valves

-The restoration of function in complex tissues like the spinal cord

-Going after the goal of regenerating more complex tissues and neo-organs

-Tackling big challenges, like the identification of cell sources and clinically relevant cell numbers, the integration of new cells into existing tissue matrices, and the accomplishment of functional properties of tissue equivalents using expanded range of biomaterials

Contact your life sciences consulting group for more information and guidance on how to make the most of the regenerative medicine market.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves.

Kinds of inspections

-The most common FDA inspection is the ‘routine inspection’, prompted by a New Drug Application (NDA) submission.  The typical candidates for a routine inspection are clinical sites that enroll the majority of patients in the NDA’s critical clinical  trials.

-‘For Cause inspections’ are not common, and are prompted when the FDA receives a report of, or becomes aware of, suspicious behavior.  Here are some reasons that may bring about such an audit:

_ The carrying out of many clinical trials

_ The carrying out of clinical studies outside of your specialization field

_ The reporting of much better effectiveness, less unfavorable effects, or different laboratory results from other sites studying the same drug

_ Having noticeable access to a large number of patients with a specific disease state for the setting

_ Complaints from a patient or sponsor in regards to regulations, protocol, or human rights violations

-Customer complaints that may trigger a product recall

How it all starts

It all starts with a phone call.  The FDA will call to program an inspection at a time that is agreed between both parties and that does not interrupt the site’s activity.  Nevertheless, they will only give you between 5 to 14 days notice, and will spend around 2 to 3 days on site.

You are entitled to ask what study they are going to inspect and who should be available during the visit, and contact the study sponsor immediately, because this sponsor can give you good suggestions and they are not directly notified by the FDA about clinical site inspections.

Before the inspection, gather these documents for the study in question:

-Protocol

-Investigator’s brochure and IND Safety Reports

-Form FDA 1572 with accompanying CVs

-IRB correspondence, including approval documentation and final report to IRB and Sponsor

-IRB-approved Informed Consent form

-IRB-approved advertising

-Correspondence related to the study, excluding investigator agreement and financial information

-Monitor sign-in log

-Laboratory certification documents

-Drug accountability records

-Each subject’s signed informed consent

-Assess support areas, like pharmacy or lab, to make sure they are properly prepared.  The FDA may tour the facility

Be ready to answer these questions:

-    Where was the study done?

-    What special equipment was used?

-    Who assisted in doing the study?

-    What were each person’s specific responsibilities?

-    Describe the sponsor’s monitoring procedures and your interaction with the monitor.

-    How did you account for the drug received, distributed to, or returned from subjects?  Were all drugs returned to the sponsor?

Train your personnel to relate to the FDA.  You must show you are a professional and should answer questions in a direct way, without giving information they haven’t requested.

When the inspector arrives

First, check his ID, because you don’t want an unauthorized person checking your files.  The inspector will fill a Notice of Inspection (FDA Form 482) and will hand it to you.

1.The inspector will begin by determining the nature of the investigator’s conduct of the study.  He may want to tour the facilities and talk to everyone who took part in the study.

His intention is to establish the level of delegation of the investigator’s authority, where specific procedures were performed, where and how the data was gathered, and where the drug was accounted for and stored.

These things are normally checked:

-Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports

-Totality of accountability documentation for the receipt, storage, administration, and return of test article (drug, device, etc.)

-Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor

-Aptness of the informed consent process

-Timely and full reporting of adverse events to the IRB and sponsor

-Compliance with the record retention requirements and that the investigator had instant access to the study records during the trial

-Ample monitoring of the site and communication with the sponsor

2.The inspector will move on to audit the data.  He will compare the data submitted to the FDA with the medical charts and source documents that support it.

He will review data from before and after the subject’s participation to make sure the subject had the medical condition under treatment and that excluded medications were not given to him or her during the study period.

3.After finishing the audit, the inspector will meet with the investigator to talk about the results.  Any inconsistencies will be registered on FDA Form 483, of which you will receive a copy.

4.The inspector will write an Establishment Inspection Report (EIR) that will be sent to the FDA for evaluation.  You will receive a letter after this evaluation is finished.

This letter may show one of three scenarios:

-It may simply recognize that the inspection was done and that nothing significant was found.

-It may list deficiencies found during the inspection, but may point out that no response is necessary.  Nevertheless, it is important that the site acts on these deficiencies in view of future inspections.

-It may point out serious negative discoveries.  The site and the data are at risk here, and you must answer immediately to clarify what steps you will take to solve the situation.

Get the help of your sponsor, because the pharmaceutical company has lots to lose too, and contact your pharmaceutical consultant for guidance and support.

If you do not respond correctly, you may be banned from performing other studies; your study data, or even the whole marketing application, can be rejected; and you may even face criminal charges.

The EIR is available, upon request, to the site, sponsor, and general public, after 4 to 6 months through the Freedom of Information Act.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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There are two types of diabetes:

-Type 1, which accounts for 5 to 10% of worldwide diagnosed diabetes cases.
-Type 2, which accounts for 90 to 95% of the totality of diagnosed cases.

The treatment for Type 1 diabetes depends on diabetic medical supplies, above all, diabetes drugs and insulin, while Type 2 diabetes is normally treated by getting involved in the patient’s life.

The World Health Organization estimates that there will be over 350 million diabetics by 2030.  This huge number clearly shows that the diabetes market will be strongly influenced, particularly the market related to diabetes drugs, which includes injections like the insulin and exenatide types, and oral drugs like Metformin, Sulfonylureas, Thaizolidinediones, Dipeptidyl inhibitors, Meglitinides, Alpha Glucosidase inhibitors, and combination medications.

Presently, cases of diabetes are growing all over the world at a very fast pace.  The causes for this incidence are several, among which we can name:  increased life expectancy, inactive lifestyles, and rising rate of obesity.

The majority of developed and developing countries worldwide suffer from these three factors, and this is why diabetes is becoming an epidemic.

In Brazil, the diabetes drug market is permanently showing a double-digit growth rate.  The insulin market in Russia is expected to grow drastically due to the 20 million Russians that are presumed will become diabetic by 2025.

China is currently the country with more diabetics, and it is expected to have over 71 million people with the illness by 2025; but India will soon top the list, and this is why many pharma companies in India have already launched insulin versions that are easy to use, in hopes of dominating the diabetes market in this country.

Diabetes is very rapidly becoming one of the most important areas in the pharmaceutical industry, and from 2010 until 2025, the market’s growth will speed up dramatically.

Following are some indicators that reveal the future of the diabetes market and that are the focus of pharmaceutical consultants and their top clients:

-The diabetes market will have access to highly superior diabetic products.

-Research and development for diabetes therapies will center on technologies that enhance clinical effectiveness, tolerability, and simplicity of use.

-Insulin has the largest market share among the treatments for this disease, with a piece of 45%, and it is expected to rule the market until the year 2025.

-The future influence of inhaled insulin in the market is not clear yet.

-Another important piece of the market is taken by pre-insulin, which has developed a lot of safer and novel diabetes therapies like the DPP-IV inhibitors and GLP-1 analogs.  These therapies’ comparative performance will probably shape the market 2013-2014, and in the long run, until 2025.

-After the new FDA guidelines were released in December 2008, pharma companies that work on diabetes drugs have had to perform more thorough studies to prevent ‘unacceptable’ cardiovascular risk.  They have to perform meta analyses for cardiovascular safety during Phase II and III trials, and must discard the chance of an increased cardiovascular disease risk by 80% or more.  What this means is that safer options of anti diabetes drugs are just around the corner.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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ZS Associates, a marketing consulting firm, has issued a report showing that just 58% of doctors are open to reps, meaning that they meet with 70% of the sales people who visit them.  This percentage shows a drop of 18% from last year.

In the same way, doctors that completely refuse to meet with reps account for 9% of the total, while last year they were 6%.  In one year, the percentage has doubled.

But the trouble doesn’t stop there.  The doctors that are open to sales reps are getting pickier, almost all of them are not willing to see reps more than once a month, not even their favorite ones.

According to this data, it is estimated that about 8 million planned sales calls are worthless, since companies are assigning reps to call on doctors who absolutely decline seeing them or who won’t see them as often as management would like.  To put it simply, this is a waste of time and money, more exactly, a waste of $1 billion a year.

How does this leave pharma marketing?

On one side, it kind of exonerates pharma sales reps, because management should be able to accept that doctors won’t open up just because they are forcing their reps on them.

On the other side, it is an indicator for the need of a more efficient sales model, where marketing efforts are adapted to local conditions.  In places where doctors are very unfriendly, it may be more beneficial to establish new strategies like online detailing, for example.  Doctors who want to see reps only once a month should be respected and contacted only within the time frame they consider acceptable.

Your pharmaceutical consultancy firm will confirm it; the worse you can do, image, money, and employee satisfaction wise, is to force yourself on others out of desperation; that will only bring you down faster and more painfully.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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You can base your selection on the criteria established by the FDA and on the type of work your company does; for example, a good option would be a crucial Phase 3 study that was recently completed and includes a good number of subjects, and it is also important to consider the accessibility of the data and the staff that will participate in a specific study.

First, choose a location and a study, and later develop a plan for your mock audit based on your SOPs and on the right FDA compliance program manual.

This plan should clearly state:

-The audit’s goals
-The project and location you chose
-The participants
-The time frames for completing the audit

Be very diligent when addressing the requests for information that the mock inspector will issue, taking into account the significant questions about regulatory knowledge, data validation, observance of SOPs, and compliance documentation.

Even more so, include an educational program into the mock audit process.  Define how and when the participants will be “debriefed”, and how you will follow up on the lessons learned from the exercise.

Once you start the mock audit, make it as real as possible.  Follow a clear plan and treat the mock inspector exactly as you would treat the real one.  Everyone must remain “in character” throughout the whole process to get the best out of the activity.

It can be educational to invite managers, executives, and members of other projects to observe the mock audit; and it is because of the educational aspect that the mock audit requires immediate and thorough review of the lessons learned after it is finished.

The review process has to include:

-Comments from the mock inspector in regards to what was done well and what needs improvement.

-Observations from the QA team and others who witnessed the activity.

-Input from the participants about what happened during the audit and about the value of the activity.

-The creation of an action plan to take care of compliance issues and organizational deficiencies that surfaced during the exercise.

-A follow-up report to make sure the action plan is put into practice.

Take advantage of the debriefing process to ask the participants about any negative feelings that came up during the mock audit.  A mock inspection may upset people, make them feel they were treated unfairly or criticized, or that the issues uncovered could be held against them.

Managers and executives who participated must make sure everyone understands that the results will not affect anyone’s job; otherwise, future mock audits will lose effectiveness due to employee fear.

Mock audits must be a regular practice of any pharmaceutical company’s training program; thus, it requires full management support and staff participation.

Pharmaceutical consultants believe that when these exercises are held at regular intervals, more and more people share the learning experience, and the company can regularly improve its level to face real audits as well as its operational systems.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention our Pharmaceutical Consultancy blog as the original source).

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The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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Within the pharmaceutical industry, it is not easy to find a Quality System model that offers a meeting point for agreement, be it direct or indirect, with the FDA’s cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies.

However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites.

The quality systems model proposed by the FDA is divided into four major categories:

1.Management responsibilities
2.Resources
3.Manufacturing operations
4.Evaluation activities

Here, we’ll discuss the first category, Management Responsibilities, and how many administrative chores related to pharmaceutical Quality Systems management could be automated.

According to the Quality System model proposed by the FDA, management staff in pharmaceutical environments has two main responsibilities:

-First responsibility: “Senior management must show commitment to developing and maintaining their Quality System.”
Developing a Quality System is a task that takes time and requires dedication.

Even if a quality manager knows a lot about the difficulties and particulars of different Quality System models, he or she will most definitely have to show commitment to developing the Quality System itself.

The management staff also holds the responsibility of maintaining the Quality System.  There are five stages linked to Quality System maintenance:

1.Observation of the Quality System
2.Identification of deviations and nonconformance events
3.Reporting
4.Analysis
5.Appropriate action

Management has to be accountable for every stage of Quality System maintenance and normally will hold the biggest responsibility in regards to data analysis and later decision making.

In spite of this, it is common to see managers spending most of their energy on the first three levels, which are the ones that pose the heaviest burden and are also the ones that are perfect for automation.

The benefits of automation are very clear:

_More time for analysis and associated research
_Less administrative responsibility

There are software options that act as an “observer” of the company’s quality system, and with these, quality management staff in regulated pharmaceutical environments can benefit from the advantages of automation.

These solutions should offer data and trending technology that simplify the identification of Quality System deviations and nonconformance events, as well as sophisticated auditing capabilities, and should allow for the effortless creation of reports that show data trends.

With good automation technology in place, management will still hold the major responsibilities in regards to Quality System maintenance, but timely and uninteresting administrative chores disappear from the picture.

-Second responsibility: “Quality System plans should be aligned with a manufacturer’s strategic plans to ensure that the system is part of the manufacturer’s mission and quality strategies.”
A Quality System is not an entity unto itself, it meddles in everyone’s business, and this is why it is crucial that the Quality System be linked to other pharmaceutical systems and processes’ goals and realities.

Nevertheless, it may not be easy to line up Quality System management with the other processes and departments because these have a tendency to be disorganized and subjective.

Good automation will let pharma companies connect quality, compliance, and everyday routine processes with solutions that take-off from one platform.  This sole platform offers two benefits:

-Faster and more effective communication between departments
-Less quality system errors due to manufacturing and quality disconnects

Within pharmaceuticals, the aspects of management responsibility seem countless, but there are modern quality management solutions that have been designed to consolidate and greatly simplify the job of pharma management staff.

Your pharmaceutical consulting firm has powerful inside information to guide your choice of quality management solutions for your company.  They are there to help you make the right choices!

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

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The conference was hosted by the Children’s Mercy Hospitals and Clinics, and its goal was to apply genomic tools to medical problems so as to tailor treatments to the unique requirements of children patients in order to improve results.

The conference’s organizer, Stephen Spielberg, MD, PhD, Director of the Children’s Mercy Center for Personalized Medicine and Therapeutic Innovation; Marion Merrell Dow Chair in Pediatric Pharmacogenomics; and Professor of Pediatrics, University of Missouri- Kansas City School of Medicine, stated that personalized medicine utilizes the latest developments in genomics and molecular data so that they can give the correct medication to the correct patient, in the correct dosage, and at the correct time.

He added that right now, a lot of medications work just for about 50% of the patients who take them, thus, personalized medicine shows high potential to transform the way in which they treat diseases.

During the conference, different experts from academia, government, and the private sector in the US, Canada, and Japan shared their knowledge of clinical applications, bioethics, and the development of pediatric personalized medicine programs.

Some of the clinical applications that were discussed were from the research programs being run at the Children’s Mercy, which tackle significant patient challenges like:

-Applying genomic strategies to improve the safety and efficiency of medications employed to treat cancer in children.

-Improving the effectiveness and benefit/risk percentage of a common therapeutic agent in treating Juvenile Idiopathic Arthritis, where inter-patient inconsistency causes 40% of the patients to fail to see results.

-Revealing genetic and developmental factors that contribute to the risk of serious adverse drug reactions in children.

-Identifying a non-invasive marker for inflammation concerning asthma, allowing doctors to predict correctly if the patients will respond to steroid treatment, and if not, guide them in the direction of better therapies.

-Utilizing genetic biomarkers to forecast which newborns are in danger of developing hyperbilirubinemia, which is the most common reason why newborns are hospitalized; up to 85% of readmissions during the first two weeks of life are due to this condition.

The occasion also prompted exchanges that help address crucial concerns created by personalized medicine, for example:

-Genetic discrimination
-Cost-benefit analysis
-Universal standards for managing genomic information in electronic medical records
-Biobanking
-Strategies to educate practitioners and patients

Children’s Mercy Hospitals and Clinics is a national leader in pediatric personalized medicine, and they are about to launch two new programs to increase medication safety:

-The outpatient Personalized Medicine and Therapeutic Innovation Clinic

-An inpatient adverse drug reaction program

Both programs will deliver first-class drug therapies, encouraging the use of discoveries to impact treatment decisions.  The clinics will be open to referrals of patients that show diagnostic and therapeutic challenges and are not responding to a therapy in progress or have had a sudden, unfavorable reaction to a certain medication.

The personalized medicine clinic will offer better therapies for children by using various approaches, which include genomic technologies and the cooperation between clinical pharmacologists and pediatric subspecialists.

Contact your life sciences consulting firm for more information about the future of personalized medicine.

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One reason why organizations use audits is to reduce cost and improve quality control.  They do this by creating the leverage of expertise of product and service providers as an alternative, instead of building equivalent capabilities in-house.  This way of outsourcing partnerships between pharmaceutical companies and external pharmaceutical vendors has reached the top of many companies’ strategic imitative plans in recent years.  This system of vendor auditing is being used by different companies, in different industries all over the world, but has really gained ground as a reliable business principle in the pharmaceutical industry.

The FDA requires that all inherent systems used to support agency regulated activities need to be validated and compliant with FDA rules and regulations.  In more precise words, the system administrator is responsible for demonstrating that the application that was developed and tested is operating and maintained according to FDA quality control standards.  In addition to this, the system administrator needs to be able to demonstrate the proper use of the procedural and technical controls, and that all applicable regulations are met.

The primary areas that need to be evaluated in a vendor audit are vendor viability, management responsibility, system accuracy, and data integrity.  The main objectives for a vendor audit are to assess the quality management of the whole organization, through its procedures and data processes.  It is an assessment of quality control measures taken by the vendor to assure that their products and services are acceptable for business transaction.  During this audit they will also verify computer systems developed or used by the vendor, make sure they meet all of the regulatory requirements, as well as have the testing documentation requirements.

A vendor audit should not be only limited to making lists of good or bad things.  It should be looked at more as an overall assessment of finding, from which you can draw your own conclusion.  A vendor audit should be conducted to help your organization make quality decisions about services, products, vendors, and quality practices.  It will provide your company a means to verify that third party vendors meet the applicable FDA laws and regulations, while reducing liability and effort on your part.

When done correctly a vendor audit can provide a great value to your company and organization, especially, in the system implementation and validation process.  It allows for vendors and buyers to quickly establish relationships that will not only increase product quality, but reduce duplicated testing efforts, and start a new and constructive dialogue between buyer and vendor.  To learn more about how to properly administer vendor audits in your company, contact a leading pharmaceutical consultant in your area.

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