Author Archives: Sentry

PIC/S Committee Meeting

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee met recently on February 9-10, 2017.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as a non-binding, informal co-operative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. PIC/S presently comprises around 50 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia) including the U.S. FDA, Australia’s Therapeutic Goods Administration (TGA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA), and the EMA is a recognized partner of PIC/S working closely with the group to provide training and develop harmonized guidance documents. A committee of the participating authorities’ representatives (PIC/S Committee) supervises the organization’s activities and all decisions are taken unanimously.

PIC/S intent is to harmonize inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating cooperation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.

At the meeting in February, the PIC/S Committee reviewed a strategic plan (Road Map) for 2017-2019 which includes an objective to and ensure the full implementation of the PIC/S Inspectorates’ Academy (PIA).

The PIA is a PIC/S initiative to set up a web-based educational center under the PIC/S umbrella, which aims at harmonizing and standardizing GMP training at an international level through a certified qualification system. PIA delivers not only general or advanced training but also serves as a platform for discussion and sharing among regulators. It offers a single point of access to all PIC/S training activities and is being implemented in various stages.

The training of GMP inspectors has been at the core of PIC/S activities since its inception, however, PIC/S has also opened some of its training tools to inspectors active in other areas such as Good Distribution (GDP) and Good Clinical Practices (GCP).

In addition to the PIA, PIC/S offers an annual Training Seminar for inspectors, with each Seminar dealing with a specific topic. The Seminars are hosted by a different PIC/S regulatory authority each year and results in the setting up of a Drafting Group, which develops new or amends existing GMP guidance documents.

Other avenues for training and exchange supported by the organization include the PIC/S Joint Visits Programme which teams up inspectors from three different countries to observe GMP inspections in each country, as well as “Expert Circle” groups to enable inspectors to discuss and exchange information on specific technical areas of GMP, develop draft guidance documents, and to provide for training opportunities in their field of expertise. Expert Circles on Human Blood, Tissues, Cells and Advanced Therapy Medicinal Products (ATMPs), Computerised Systems, Active Pharmaceutical Ingredients (APls), Good Distribution Practices (GDP) and Quality Risk Management (QRM) are currently active and meet regularly.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The focus of our post this week is Parkinson’s Disease and treatment.  Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

DEA Warns Public of Extortion Scam by DEA Special Agent Impersonators

Sentry BioPharma Services is helping the Drug Enforcement Administration to warn the public about criminals posing as DEA Special Agents or other law enforcement personnel as part of an international extortion scheme.

The criminals call the victims (who in most cases previously purchased drugs over the internet or by telephone) and identify themselves as DEA agents or law enforcement officials from other agencies. The impersonators inform their victims that purchasing drugs over the internet or by telephone is illegal, and that enforcement action will be taken against them unless they pay a fine. In most cases, the impersonators instruct their victims to pay the “fine” via wire transfer to a designated location, usually overseas. If victims refuse to send money, the impersonators often threaten to arrest them or search their property. Some victims who purchased their drugs using a credit card also reported fraudulent use of their credit cards.

Impersonating a federal agent is a violation of federal law. The public should be aware that no DEA agent will ever contact members of the public by telephone to demand money or any other form of payment.

The DEA reminds the public to use caution when purchasing controlled substance pharmaceuticals by telephone or through the Internet. It is illegal to purchase controlled substance pharmaceuticals online or by telephone unless very stringent requirements are met. And, all pharmacies that dispense controlled substance pharmaceuticals by means of the internet must be registered with DEA. By ordering any pharmaceutical medications online or by telephone from unknown entities, members of the public risk receiving unsafe, counterfeit, and/or ineffective drugs from criminals who operate outside the law. In addition, personal and financial information could be compromised.

Anyone receiving a telephone call from a person purporting to be a DEA special agent or other law enforcement official seeking money should refuse the demand and report the threat using the online form below. Please include all fields, including, most importantly, a call back number so that a DEA investigator can contact you for additional information. Online reporting will greatly assist DEA in investigating and stopping this criminal activity.

Suspicious activity  may also be reported on-line by visiting the DEA’s website:

https://www.deadiversion.usdoj.gov/pubs/pressreleases/extortion_scam.htm

Sentry urges the public to use the link above to learn more about what basic pieces of information will help the DEA investigate extortion scams.

For more information about how Sentry can meet safety and regulatory demands for packaging, storage, global drug distribution and disposal of controlled substances, contact Sentry via email or by phone at 1-866-757-7400.

CDC’s 2016 National Influenza Vaccination Week (NIVW)

The Centers for Disease Control and Prevention’s (CDC’s) National Influenza Vaccination Week (NIVW) is scheduled for December 4-10, 2016.  The CDC established National Influenza Vaccination Week (NIVW) in 2005 to raise public awareness about the importance of flu vaccination.  The 2016 national awareness week focuses on highlighting the importance of influenza vaccination and continuing flu vaccination through the holiday season and beyond.  To learn more about what is new for the 2016-2017 flu season, view the CDC’s Factsheet by clicking HERE.

It's National Influenza Vaccination Week (NIVW)! Did you know that flu season can begin as early as October, it usually peaks between December and February, and it can last as late as May? As long as flu virsues are spreading, it's not too late to get a flu vaccine to protect yourself and your loved ones through fall, winter and into spring. #GetAFluVax

NIVW Timing

Flu vaccination coverage estimates from past years have shown that influenza vaccination activity drops quickly after the end of November.

CDC and its partners choose to December for NIVW to remind people that even though the holiday season has arrived, it is not too late to get your flu vaccine.  As long as flu viruses are spreading and causing illness, vaccination can provide protection against the influenza virus and should continue.

Even if you haven’t yet received a vaccine and have already gotten sick with one flu virus, you can still benefit from vaccination since the flu vaccine protects against three or four different flu viruses (depending on which flu vaccine you get).

Flu Vaccination for People at High Risk

Another goal of NIVW is to communicate the importance of flu vaccination for people who are at high risk for developing flu-related complications.  People at high risk of serious flu complications include young children, pregnant women, people with certain chronic health conditions like asthma, diabetes, heart disease or lung disease, and people aged 65 years and older.  For people at high risk, getting the flu can mean developing serious flu-related complications, like pneumonia, or a worsening of existing health conditions, which can lead to hospitalization or death.

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

To contact CDC by phone call (800) 232-4636 (800-CDC-INFO) or visit the website at

www.cdc.gov/flu/nivw .

FDA’s Know Your Source: Protecting Patients from Unsafe Drugs

Beware of Rogue Wholesale Drug Distributors

Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day.

While the U.S. health care supply chain is one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.

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Reduce the Chance of a Potentially Unsafe Drug Reaching Your Patients

In order to protect your patients from unsafe or ineffective drugs, the FDA urges health care professionals to verify that their supplier is licensed by the state. Drugs from rogue wholesale drug distributors may harm your patients and expose them to unknown risks or side effects.  The FDA advises health care providers to know the source for prescription drugs.

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Verify that Your Wholesale Drug Distributor is Licensed in Your State

map

http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

For more information about Sentry’s pharmaceutical licensing, registration and international compliance program, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

DoD | Human Trials Begin for Army-Developed Zika Vaccine

By Cheryl Pellerin, DoD News, Defense Media Activity / Published Nov. 8, 2016

A clinical trial began yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists developed earlier this year, Walter Reed officials announced today.zika

Laboratory-confirmed Zika virus disease cases reported to ArboNET by state or territory as of Nov. 2, 2016. ArboNET is a national surveillance system for arthropod-borne virus diseases in the United States, such as those from ticks and mosquitoes.

The Phase 1 trial will test the safety and immunogenicity — the ability of the vaccine to trigger an immune response in the body — of the purified, inactivated Zika virus vaccine called ZPIV. The vaccine is being tested at WRAIR’s Clinical Trial Center in Silver Spring, Maryland.

“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement.

Efficacy refers to the vaccine’s ability to demonstrate a health effect when tested in a clinical trial.  “All of this,” he added, “was done in 10 months.”

Dr. Kayvon Modjarrad, Zika program co-lead and associate director for emerging infectious disease threats at WRAIR’s MHRP, said the Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine “because of its extensive experience with this vaccine platform and longstanding investments in the understanding and mitigation of flaviviruses like yellow fever, dating back to the founding of WRAIR.”

DoD Zika Response

WRAIR officials say this study is part of the Defense Department response to the ongoing Zika outbreak in North and South America and Southeast Asia.

For service members, there are concerns about infection during deployment and travel, but also in the continental United States, where most military installations are concentrated in southern states. There, climate conditions and mosquito populations favor Zika transmission, WRAIR officials say.mosquito

Zika virus is transmitted to people primarily through the bite of an infected Aedes species mosquito — Aedes aegypti, shown here, and Aedes albopictus. The same mosquitoes spread dengue and chikungunya viruses. The mosquitoes typically lay eggs in and near standing water in things like buckets, bowls, animal dishes, flower pots and vases. They prefer to bite people and live indoors and outdoors near people. Mosquitoes that spread chikungunya, dengue, and Zika are aggressive daytime biters, but they can also bite at night. Mosquitoes become infected when they feed on a person already infected with the virus. Infected mosquitoes can then spread the virus to other people through bites. CDC photo by James Gathany

As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.

Zika infection during pregnancy, CDC says, can cause a birth defect of the brain called microcephaly and other severe fetal brain defects.

Other problems have been detected among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. And reports have increased about Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika, CDC says.

But even Zika infections without symptoms “can lead to severe birth defects and neurological complications,” Zika study principal investigator Army Maj. (Dr.) Leyi Lin said, adding, “A safe and effective Zika vaccine that prevents infection in those at risk is a global public-health priority.”

Zika and Other Flaviviruses

Flaviviruses like Zika are found mainly in mosquitoes and ticks and cause widespread morbidity and mortality worldwide. Other mosquito-transmitted viruses that are members of the flavivirus genus include yellow fever, or YF, dengue fever, Japanese encephalitis, or JE, and West Nile viruses, according to the CDC web page.

“We want to assess the safety and immune response of the ZPIV vaccine in JE and yellow fever YF vaccine recipients because these vaccines may alter the response to the ZPIV vaccine,” Lin said.

“Uniquely,” he added, “illness as a result of natural infection from JE, YF or Zika could be more severe when prior flavivirus infection or vaccination exists. Our study assesses co-vaccination to learn how to reduce risk when protecting against circulating flaviviruses.”

This is important for service members who are vaccinated against other flaviviruses and then stationed in or deployed to areas where Zika is becoming endemic, WRAIR scientists say.

Zika Vaccine Platform

WRAIR’s inactivated flavivirus vaccine platform was the same technology the institute used to create its Japanese encephalitis vaccine, licensed in 2009.

An earlier preclinical study found that rhesus monkeys vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus.

The National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing and is sponsoring the conduct of this trial.

WRAIR, NIAID and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, have established a joint research collaboration agreement to support the vaccine’s development.

The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger-scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure, according to the WRAIR release.

Other ZPIV Trials

WRAIR’s ZPIV candidate also will soon be part of an NIH trial that began in August. The NIH vaccine contains DNA that instructs volunteers’ cells to make certain Zika proteins that then illicit an immune response. As part of that study, WRAIR’s ZPIV vaccine will be given to volunteers as a booster after they receive the NIH DNA vaccine, WRAIR officials say.

Three more Phase 1 trials using ZPIV are scheduled to begin this year, the WRAIR release noted:

— St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.

— Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.

— The Ambulatory Center for Medical Research, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine’s safety and immune response in participants who have already been naturally exposed to Zika or dengue viruses.

The WRAIR trial that began yesterday is sponsored by NIAID and funded by the Army and the Defense Department.

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.defense.gov/DesktopModules/ArticleCS/Print.aspx?PortalId=1&ModuleId=753&Article=999584

CDC Report: First cases of Candida auris reported in U.S.

On Friday, November 4, 2016 the U.S. Centers for Disease Control and Prevention (CDC) announced the first cases of Candida auris were reported in the United States (U.S.).candida_strain

A strain of Candida auris cultured in a petri dish at CDC.
Photo Credit: Shawn Lockhart, CDC

Thirteen cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally, have been identified in the United States, according to the CDC. Seven of the cases occurred between May 2013 and August 2016 and are described today in CDC’s Morbidity and Mortality Weekly Report (MMWR). The other six cases were identified after the period covered by the report and are still under investigation.

The following map displays where Candida auris cases have been identified in the United States as of November 4, 2016.

candida

Source of map: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

The report is the first to describe U.S. cases of C. auris infection. C. auris is often resistant to antifungal drugs and tends to occur in hospitalized patients. In June 2016, CDC issued a clinical alert describing the global emergence of C. auris and requesting that laboratories report C. auris cases and send patient samples to state and local health departments and CDC. Since then, CDC has been investigating reports of C. auris with several state and local health departments. The agency expects to continue to investigate possible cases as awareness of the emerging infection increases.

“We need to act now to better understand, contain and stop the spread of this drug-resistant fungus,” said CDC Director Tom Frieden, M.D., M.P.H. “This is an emerging threat, and we need to protect vulnerable patients and others.”

Among the seven cases detailed in the report, patients with C. auris were reported in four states: New York, Illinois, Maryland and New Jersey. All of the patients had serious underlying medical conditions and had been hospitalized an average of 18 days when C. auris was identified. Four of the patients died; it is unclear whether the deaths were associated with C. auris infection or underlying health conditions.

In two instances, two patients had been treated in the same hospital or long-term-care facility and had nearly identical fungal strains. These findings suggest that C. auris could be spread in healthcare settings.

Six of the seven cases were identified through retrospective review of hospital and reference laboratory records. Identifying C. auris requires specialized laboratory methods because it can easily be misidentified as another type of Candida infection, in which case patients may not receive appropriate treatment. Most of the patient samples in the current report were initially misidentified as another species of Candida.

Most of the C. auris strains from U.S. patients (71 percent) showed some drug resistance, making treatment more difficult. Samples of C. auris strains from other countries have been found to be resistant to all three major classes of antifungal medications. However, none of the U.S. strains in this report were resistant to all three antifungal drug classes. Based on laboratory testing, the U.S. strains were found to be related to strains from South Asia and South America. However, none of the patients travelled to or had any direct links to those regions. Most patients likely acquired the infections locally.

“It appears that C. auris arrived in the United States only in the past few years,” said Tom Chiller, M.D., M.P.H., chief of CDC’s Mycotic Diseases Branch. “We’re working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people.”

CDC recommends that healthcare professionals implement strict Standard and Contact Precautions to control the spread of C. auris. Facilities should conduct thorough daily and after-discharge cleaning of rooms of C. auris patients with an EPA-registered disinfectant active against fungi. Any cases of C. auris should be reported to CDC and state and local health departments. CDC can assist in identifying this particular type of Candida if needed.

In 2013, CDC issued a report describing antibiotic resistance threats in the United States that needed prompt action, including Candida infections. CDC’s Antibiotic Resistance Laboratory Network is providing additional lab support in four regional laboratories to test fungal susceptibility of Candida species and identify emerging resistance. CDC is also expanding tracking of this fungus through the Emerging Infections Program. Information gathered through these networks plays a key role in tracking resistance and informing policies and interventions.

The challenge of emerging antibiotic resistant threats like C. auris highlights the need for urgent, coordinated federal, state, local, and international public health response and the importance of CDC’s AR Solutions Initiative. The timely investments in the AR Solutions Initiative empower CDC to rapidly detect, investigate, and respond to emerging threats, like C. auris; prevent resistant infections from occurring and spreading across healthcare settings and the community; and innovate, supporting development of new diagnostics and drugs to test, treat, prevent infections, and save lives.

For more information about how Sentry can implement a custom solution to meet your unique pharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

For more information: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

Features & Benefits of Sentry’s Pharmaceutical Labeling & Packaging Services

Sentry BioPharma Services specializes in pharmaceutical and medical device packaging projects of varying scale, complexity and sensitivity to time and temperature. Sentry’s  full service light manufacturing through Food & Drug Administration (FDA) compliant pharmaceutical labeling and custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions to clinical sites and commercial customers across the global. This one-stop shop structure married with Sentry’s Foreign Trade Zone (FTZ) offers optimal flexibility and cost effective solutions to even the most intricate of drug development projects.

sentry-lp-photo-1

Sentry Labeling and Packaging

Features of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

GMP operation compliant with FDA regulations

o    FDA labeler code (3007066137)

o    Segregated labeling and packaging area

o    Total label operation accountability (line clearance)

 

Diverse Clinical Trial Labeling & Packaging Support

o    Open and blinded

o    Multi-lingual

o    Peel-off / Perforated

o    Serialized

 

Pharmaceutical & Medical Device Packaging

o    Bulk

o    Double-blind

o    Package inserts

o    Single / Multi-dose cartons

o    Tamper evident seals

On-Demand Services

o    Configurable stock management

o    Expiration management of individual kit components

o    Extend expiration

o    Pharmaceutical kitting

o    Reduce at-risk inventory

 

Adaptable Scheduling

o    Batch or lot specific

o    Batch size

 

Benefits of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

Streamlined Production throughout Drug Development Phases – Avoid cumbersome logistics among vendors with Sentry’s full scope services from GMP pharmaceutical storage, biopharmaceutical labeling and packaging and extensive distribution.

Accurate Inventory Control from Bulk to Finish –  Sentry’s compliant, validated inventory management system and batch record process allow for accurate tracking of inventory levels during clinical trials and commercial launch.

Cost Effective Manufacture – Reduce pharmaceutical drug development costs with Sentry’s flexible storage, labeling and packaging offerings before, during and after FDA approval.

For more information about how a coordinated GMP storage, packaging and distribution model may reduce risk and strengthen the structure of your supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Promotes Diabetes Awareness Month

November is well known for Thanksgiving in the United States, but did you know that it also national diabetes awareness month?world_diabetes_day

Sentry BioPharma Services invites individuals, health care professionals, organizations, and communities from across the country to join the National Institute of Diabetes & Kidney Disease (NIDKD) in spreading the word about diabetes in an effort to raise awareness and have a conversation about its impact on millions of Americans.

This year, the National Diabetes Education Program’s theme is: Managing Diabetes – It’s Not Easy, But It’s Worth It. This theme highlights the importance of managing diabetes to prevent diabetes-related health problems such as heart attack, stroke, kidney disease, vision loss, and amputation. The theme also serves as a reminder to people who may be struggling with the demands of managing diabetes that they are not alone.

The statistics about diabetes and prediabetes warrant global attention.  According to the American Diabetes Association, diabetes remains the 7th leading cause of death in the United States in 2010, with 69,071 death certificates listing it as the underlying cause of death, and a total of 234,051 death certificates listing diabetes as an underlying or contributing cause of death.  Further, 1.4 million Americans are diagnosed with diabetes every year.

In 2012, 29.1 million Americans, or 9.3% of the population, had diabetes.  Approximately 1.25 million American children and adults have type 1 diabetes.   Of the 29.1 million, 21.0 million were diagnosed, and 8.1 million were undiagnosed.   The percentage of Americans age 65 and older remains high, at 25.9%, or 11.8 million seniors (diagnosed and undiagnosed).

Diabetes is serious and can be a hard disease to manage. Having a plan and setting goals can help you take small steps to prevent diabetes-related health problems in the future.   A component of your plan may include disease management with medication.

While there is no cure for diabetes, there are treatment options available.  Insulin, a hormone that controls blood sugar, is commonly used to treat diabetes.  The types of insulin and brands of insulin approved by the FDA include:

Type of Insulin Brand Names
Rapid-Acting Lispro (Humalog)
Aspart (Novolog)
Glulisine (Apidra)
Short-Acting Regular (R) humulin or novolin
Velosulin (for use in the insulin pump)
Intermediate-Acting NPH (N)
Long-Acting Insulin glargine (Basaglar, Lantus)
Insulin detemir (Levemir)
Ultra-Long-Acting Insulin degludec (Tresiba) 30-90 min.
Humulin 70/30
Novolin 70/30
Novolog 70/30
Humulin 50/50
Humulog mix 75/25

 

During National Diabetes Month, make a plan to manage your diabetes. Pick non-medicinal things that you want and believe you can do. Small changes, such as walking 15 minutes, twice a day, or replacing sugary drinks with water, are small steps that can go a long way.  Ask for help from friends or family.  Managing your diabetes is not easy, but it’s worth it.  You can also visit the National Diabetes Education Program at www.ndep.nih.gov  to learn more.

For more information about how Sentry’s GMP warehouse and best-in-class processes can help you manage your insulin inventory and global drug distribution, contact Sentry via email or by phone at 1-866-757-7400.

Links:

Sentry Completes NABP’s VAWD Triennial Reaccreditation Process in Record Time!

Today, Sentry BioPharma Services, Inc. announces completion of the National Association of Boards of Pharmacy’s (NABP) Verified-Accredited Wholesale Distributor (VAWD) triennial reaccreditation process in record time.

vawd

Sentry first earned VAWD accreditation in May of 2007.  The initial certification was valid for a three-year term providing a surveillance process is successfully completed each year between triennial reaccreditation.  After the initial certification, Sentry successfully completed the triennial reaccreditation process in 2010 and 2013, respectively.vawd

Mr. Randall Higgins, Sentry’s Senior Manager of Validation and Compliance elaborates, “Sentry has been a VAWD-accredited facility for nearly 10 years now.  However, this reaccreditation cycle was different.  On August 03, 2016, Sentry submitted the first response to the Policy & Procedure review to the NABP.  On Monday, October 24, 2016, the company received formal notice from the NABP that our facility was approved.”  Mr. Higgins emphasizes, “We completed the reaccreditation process – initial submission to approval – in less than three months (11 weeks)!  That timeline is unheard of in this industry.”  He continues, “Successful completion of the VAWD triennial reaccreditation process in such a short amount of time is a testament to the team effort and caliber of talent employed by Sentry.  Sentry is very proud of the depth of knowledge and experience our leadership team possesses; the dedicated and cooperative employees capable of following strategic direction and standard operating procedures; and the 10 years of maintaining a squeaky-clean compliance record.  All of this while delivering a high-quality service offering 24/7/365.”

The NABP is a 501(c)(3) nonprofit association that protects public health by assisting its member boards of pharmacy and offers programs that promote safe pharmacy practices for the benefit of consumers.  The state boards of pharmacy play an important role in regulating the drug supply chain. State laws and regulations that the boards develop help protect the public from receiving medications that have been contaminated or counterfeited.

Currently, 24 states recognize VAWD accreditation.  Many of these states recognize VAWD as a means of implementing the licensing provisions of new laws, while mitigating the fiscal and operational impact on their board.  Of the 24 states that recognize VAWD, Indiana, North Dakota, and Wyoming require VAWD accreditation as a component of licensure.

The VAWD accreditation program was developed for wholesale drug distributors with the primary objective of protecting the public from contaminated, diverted, or counterfeited drugs.

To become VAWD-accredited and display the VAWD seal, facilities must undergo a criteria compliance review, which includes: a rigorous review of their operating policies and procedures; licensure verification; a survey of a facility’s operations; and screening through the NABP clearinghouse.

VAWD accreditation plays a pivotal role in preventing counterfeit drugs from entering the United States (US) drug supply: it helps protect the public from drugs that have been contaminated, diverted, or counterfeited. The US supply of prescription drugs is produced and delivered to patients via a complex drug distribution path, and VAWD accreditation helps ensure that the wholesale distribution facility operates legitimately, is licensed in good standing, and is employing security and best practices for safely distributing prescription drugs from prescription drug manufacturers to pharmacies and other institutions.

For more information about Sentry’s pharmaceutical licensing, registration and international compliance program, contact Sentry via email or by phone at 1-866-757-7400.

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