Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared.

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.

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Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

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).

Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

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).

Maintaining a top-functioning Quality System in regulated pharma environments can add serious problems to the company’s bottom line.  Nevertheless, the ROI can be significant with solutions that automate routine and administrative tasks related to Quality System maintenance.

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!

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A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.  The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.  This need for a closer monitoring of a vendor’s qualities and practices stems from an ever-evolving quality control market, and an industry where quality products are a necessity, not a luxury.

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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A study of almost 100 clinical trials that were stopped prematurely because they showed positive treatment effects has shown that a large number of those effects were exaggerated.

The study was published in the Journal of the American Medical Association and recommends that researchers do not fall for the temptation to end clinical trials prematurely but rather continue with them for longer periods of time before thinking about ending them.

Victor Montori, M.D., Mayo Clinic endocrinologist and one of the authors of the study, explained that they discovered that in the majority of cases where the clinical trial was stopped prematurely, the effects of the treatment were deceptive, and that these ambiguous estimations will most probably produce unwise decisions in regards to the estimation of the therapy’s risks and benefits.

He added that, “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials.  Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent.”

The clinical trials that were analyzed in the study were stopped prematurely due to a credible and normally large apparent difference between an experimental treatment and an established standard therapy.

The trials were stopped so that the people taking a placebo, or a medication that was less effective, could take the drug in trial.  In addition, this allowed doctors to prescribe the therapy earlier, since it would reach the market faster.

Dr. Montori explained that almost everyone doctors, researchers, investors, pharmaceutical firms, scientific journals, and even reporters benefits from the premature stop of a clinical trial; the only one that is affected is the patient, because he or she may wind up being treated with a therapy that is based on deceptive data in regards to its benefits.

The study investigated 63 medical questions about 91 trials that were stopped and compared them to 424 equivalent trials that remained active.  The discovery was that the trials that were prematurely stopped, especially small trials of a few hundred participants, showed effects that were exaggerated or deceptive, and these deceptive conclusions were aggravate over time because researchers wouldn’t go back to check what was previously considered a positive treatment.

It is recommended by the research team that clinical trials are stopped only when these are near the end and only for a very good reason, otherwise, patients, as much as doctors, will be making choices based on the wrong information and will be considering treatments that may not work as well as others.

The Medical Research Council of the U.K backed this study, and collaborated on it, together with Dr. Montori: Dirk Bassler, M.D.; Matthias Briel, M.D.; Qi Zhou, Ph.D.; Stephen Walter, Ph.D.; Gordon Guyatt, M.D.; and Diane Heels-Ansdell, all from McMaster University, Ontario; Melanie Lane, Mayo Clinic; and Paul Glasziou, M.B.B.S., Ph.D., University of Oxford, England.

Contact pharmaceutical consultants for more information, guidance, and to get the competitive edge you need to be the market leader in healthcare products.

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According to Mexican researchers, agave, the plant from which tequila is made, may help fight osteoporosis and other bone diseases through one of its components.

Agave, as well as artichokes, garlic, onions, and chicory, is a powerful natural source of fructans, non-edible carbohydrates that consist of molecules of fructose joined together into chains.

Experimental studies indicate that fructans could be helpful for patients with diabetes or obesity, to stimulate the immune system, to decrease levels of bacteria that cause intestinal illness, to relieve constipation, and to reduce the risk of colon cancer.

Fructans have also been shown to stimulate the growth of good bacteria in the large intestine, boosting the body’s assimilation of minerals, including calcium and magnesium, essential for bone growth.  So, even though it is not a tequila shot per se, fructans may do a lot of good to a sick person’s bones.

Mercedes Lopez, from the National Polytechnic Institute in Guanajuato, tested the agave fructans on mice bone growth.  The sample fed with agave fructans absorbed more calcium from food, expelled less calcium in their feces, and increased in 50% their levels of a protein associated with the development of new bone tissue, all three, conditions that were not observed in other mice.

The natural conclusion is that by enriching the mice’s normal diet with agave fructans, bone loss was prevented and bone formation was enhanced.  This suggests that agave fructans may play an important part in maintaining bone health.

Agave fructans can be used in many products for children and infants to inhibit several illnesses, and also used as a sugar substitute in ice cream.

Lopez clarifies that the conventional tequila shot is actually not an option, since fructans become alcohol when agave is processed into the drink.

Ask your pharmaceutical consultant for more information or research on agave fructans; there’s no better source of valid information and advice in the pharmaceutical industry.

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Starting now, and for the next 10 years, developing countries will start receiving pneumonia vaccines from GlaxoSmithKline and Pfizer Inc.

GAVI Alliance, the public-private partnership based in Geneva, recently announced this new commitment.  The program GAVI established to treat pneumococcal disease initially received $1.5 billion in funding, which came from the Italian, U.K., Canadian, Russian, and Norwegian governments, and from the Bill & Melinda Gates Foundation.

This new development promises to put new affordable vaccines in the hands of people that need them urgently.  GAVI states that the pneumococcal disease, which includes pneumonia, kills 1.6 million people per year, 800,000 of which are children under the age of five.  Over 90% of the deaths take place in developing countries, where pneumonia ends the life of one in every four children.

GAVI established the ‘Advance Market Commitment’ program to make drugs available to people in need, affirming that vaccines that are affordable could save 900,000 lives by 2015 and 7 million lives by 2030.

Glaxo will deliver 30 million doses and Pfizer an equal amount, for the next 10 years.

Pfizer is enhancing its manufacturing capacity to meet the global demand and to deliver Prevenar 13, which can be used in infants and small children throughout more than 40 countries.

Jeffrey Kindler, Pfizer Chairman and CEO, affirmed that, “Pfizer is dedicated to broadening access around the world to our medicines, and public-private partnerships such as the one involving the Advance Market Commitment are critical to achieving true inroads on this front.”

Glaxo announced it invested over $400 million to build a manufacturing plant in Singapore that will be devoted to producing hundreds of millions of doses of Synflorix, the drug it will be delivering, in the next years.

These vaccines will start being sold at $7 the dose, however, the price will drop to $3.50 and will remain so for the long run.  The vaccines will be paid by GAVI and the developing countries they will benefit.

According to GAVI, the total cost of the pneumococcal vaccines is only a fraction of their current cost in many industrialized countries.

Ask your pharmaceutical consulting firm for information and guidance to gain the competitive edge you need to be the market leader in healthcare products.

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The impact of influenza can only be reduced through a vaccine.  Today, the U.S. has only approved the use of inactivated influenza virus vaccines, and to be effective, these have to contain an H1N1, and H3N2, and a B virus component.  In the past, at least one of these components had to be modified due to antigenic drift of the strain circulating the human population.

Vaccines are prepared by growing viral strains in embryonated eggs, and then the virus is purified and turned noninfectious through chemical inactivation.  The influenza vaccines available today are effective depending on the antigenic ‘match’ of the circulating viruses with the strains used for vaccination, the person’s age, and his or her immune status.

Here’s what is expected in the future; ask your pharmaceutical consultant for further details:

1.    Cold-adapted influenza virus vaccine
This type of live vaccine has been used successfully in Russia to protect millions of children.  The U.S. has been trying to develop such a vaccine for over 20 years, but the license has not been approved yet.

There are several important advantages here:

-    Live-virus vaccines can be administered through nasal spray, which is easier and less costly than the intramuscular option.

-    These can induce local neutralizing immunity and cell mediated immune responses, which could result in a longer-lasting and better cross-protective immunity.

-    Overall protection may improve for certain age groups, for example, kids 6 months to 9 years of age, with evidence of a massive reduction in secondary bacterial infections causing otitis media.

The more live influenza virus vaccines are used, the more benefits, risks, and economic consequences of this approach will be known.

2.    Genetically engineered live influenza virus vaccines
The introduction of techniques to engineer site-specific changes in the genomes of negative-strand RNA viruses has allowed the consideration of new vaccine approaches.  It is possible now to create strains with unique properties that lead to reduction.

3.    Live influenza virus vaccine candidates expressing altered NS1 genes
Now it is possible to rescue influenza virus vaccine candidates from cells transfected with plasmids.  This allows for the engineering of deletions in genomes of influenza viruses for better stability.

4.    Use of replication-defective influenza viruses as vaccine candidates
This is a promising approach, the construction of virus particles that undergo only a single cycle of replication.  These induce a protective antibody response and stimulate a strong cell-mediated immune response without allowing the replication of infectious virus.

5.    DNA vaccination
This involves the administration of plasmid DNA encoding one or more of the influenza virus proteins.  Studies have been limited to animal samples with very promising results; however, this type of vaccine may be better for diseases like AIDS.  Further studies may present a universal approach to generating protective humoral and cell-mediated responses to different foreign antigens, resulting in the development of effective vaccines.

6.    New adjuvant approaches
Current influenza virus vaccines are administered by intramuscular injection.  To improve their immunogenicity, liposome-like preparations have been developed, which contain cholesterol and viral particles that are very effective in mice when delivered subcutaneously or in intranasal form.  More tests are needed to confirm how it will work in humans.

7.    Universal vaccine
This has been the focus of increased attention due to the current necessity to develop a new vaccine every year given the influenza virus’ continuous antigenic change.  Even though some virus components are more conserved than others, a good approach to a universal vaccine based on these conserved elements is still pending, because these are minor antigens, and thus, are less immunogenic and less likely to create a protective response.

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Laboratory personnel are exposed to a high risk of injury due to repetitive movements during normal lab procedures like pipetting, microscope use, operating microtomes, using cell counters and video display terminals.  This type of injury develops with time and it happens when the muscles and joints are stressed, tendons are swollen, nerves are pinched, and blood flow is restricted.  Another health risk for lab workers comes with standing and working in uncomfortable positions in lab hoods and biological safety cabinets.

Here we show you several ways to control some of these risk factors and to ensure your personnel is working in a comfortable, productive, and safe lab environment.

1.    Pipetting
This task involves various ergonomic strains like thumb force, repetitive movements, and awkward postures of the wrists, arms, and shoulders.  In order to alleviate these hazards follow these tips:

-    Use pipettes that fit comfortably in the user’s hand and that have triggers that need less force to be activated. Also, aspirate with the pointer finger and dispense with the thumb.

-    Use an electric pipette with mixing function to mix and aliquot, and use multichannel pipettors for big aliquot jobs.

-    Use shorter pipettes that decrease hand elevation.

-    Use low profile waste containers for used tips.

-    Take 3-5 minute breaks for every 20-30 minutes of pipetting, exercise and stretch your hands and arms while resting.

-    Clean pipetters regularly.

-    Adjust the workstation so that the employee can work with arms close to the body.

-    Rotate pipetting with other lab tasks and people.

-    Use thin wall pipette tips that fit correctly and eject easily, and use minimal force when applying them.

-    Maintain samples and instruments within easy reach.

-    Use an adjustable chair when sitting at a lab bench.

-    Use anti-fatigue mats when you need to stand for an extended period while pipetting.

2.    Computer workstation
Some researchers spend long hours entering data with a keyboard and mouse over a very high bench, making the person elevate the arms excessively.  This is what you need to do:

-    Install adjustable keyboard trays under the benches, and monitors at viewing distance between 18 and 30″ and with top of screen at eye level.

-    Locate computers away from doors, entrances, and passageways.

-    Use adjustable seating.

-    Hold documents adjacent to and in the same plane as the screen.

-    Install foot rests.

-    Offer different keyboards and mouse attachments for personnel with muscle problems.

-    Order 2-5 minute breaks for every 20-30 minutes of computer use.

-    Do not go from keyboarding to pipetting or vice versa without resting at least 15 minutes.

3.    Microscopy
Microscopy workstations must be adjustable to fit every size of person:

-    Don’t use a microscope for more than 5 hours per day.

-    Locate the microscope on the edge of the table to achieve an upright position.

-    Use a cut-out work table.

-    Elevate the microscope and place it at an angle at which you can look directly into the eyepiece.

-    Keep neutral spine.

-    Give arm rests for while using the adjustment knobs.

-    Use an ergonomic chair with good back support.

-    Ensure there is enough room under the table so that the person can pull the chair up to the ocular.

-    Install footrests and avoid foot rings on stools.

-    Provide sit-stand seats for areas with little leg room.

-    Order regular breaks.

-    Use television systems instead of binocular eyepieces.

4.    Overhead Lifting
Lack of space can force you to store equipment and supplies on overhead shelves, if this is so, follow these tips:

-    Store heavy objects on lower shelves.

-    Use a stable stool or ladder to reach overhead shelves.

-    Do not twist while you lift.

-    Use rotating carrousels to store materials close to the worker.

The well being of personnel is vital for the good functioning of any laboratory.  Any pharmaceutical consultant will agree that people are a pharmaceutical company’s strongest asset; by caring for their health you are taking your company far ahead in the 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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