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Purified Water Monograph: New Draft in European Pharmacopoeia 9.4

12/17/2017 07:31:57 AM

A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities:“Elemental impurities: If purified water in bulk does not meet the requirement for conductivity ...

Strain Collection for Improved Expression of Outer Membrane Proteins

12/16/2017 07:00:14 AM

An article of interest in Frontiers in Cellular and Infection Microbiology. Here is the abstract:Almost all integral membrane proteins found in the outer membranes of Gram-negative bacteria belong to the transmembrane ?-barrel family. These ...

How Helicobacter pylori causes gastric cancer

12/15/2017 08:00:07 AM

Gastric cancer is one of the five most fatal types of cancer. According to the statistics of the World Health Organization (WHO), about 750,000 patients die each year after developing the disease. The main cause is thought to be the bacterium ...

Possibility of pumping antibiotics into bacteria

12/14/2017 08:00:26 AM

Researchers have discovered that a cellular pump known to move drugs like antibiotics out of E. coli bacteria has the potential to bring them in as well, opening new lines of research into combating the bacteria.Cells must bring in and remove ...

Mapping the microbiome of ... everything

12/13/2017 08:00:04 AM

In the Earth Microbiome Project, an extensive global team has collected more than 27,000 samples from numerous, diverse environments around the globe. They analyzed the unique collections of microbes -- the microbiomes -- living in each sample ...

Novel antibiotic resistance gene in milk

12/12/2017 07:30:00 AM

A new antibiotic resistance gene has been found in bacteria from dairy cows. This gene confers resistance to all beta-lactam antibiotics including the last generation of cephalosporins used against methicillin-resistant Staphylococcus aureus. ...

Gut bacteria linked to age-related conditions

12/11/2017 06:30:43 AM

New research shows for the first time that an imbalance in the good and bad bacteria in the gut of old mice causes inflammatory responses in young mice -- responses that are linked to age-related conditions such as stroke, dementia and card ...

WHO’s Global Tuberculosis Report 2017

12/10/2017 08:00:35 AM

Statement from Mel Spigelman, president and CEO of TB Alliance“TB is still, tragically, the world’s most deadly infection. And yet, efforts to curb this ancient disease remain woefully under-resourced.“We need new tools—new drugs, d ...

Antibiotic resistance infographic

12/09/2017 07:30:07 AM

Acording to the Centers for Disease Control and Prevention (CDC), up to 30 percent of antibiotics prescribed in America are unnecessary. The figure is based on a study that analyzed the use of antibiotics in emergency departments and doctors’ ...

Pharmig News #69

12/08/2017 07:30:53 AM

A new edition of Pharmig News has been issued, edition 69. In this issue:Industry reflections by David Keen.Part 2 of Pharmig’s industry review of culture media practices.Review of MHRA deficiencies – trends and topics.Regulatory round-upNew ...

5 Keys To Aseptic Processing Improvement & Efficiency

12/07/2017 07:30:46 AM

Today, life science products should also be affordable to patients and a reasonable business proposition for manufactures. These objectives can present challenges to manufacturers as they strive to gain production and process efficiencies.Hal ...

Data-Driven Risk Management For Quality By Design

12/06/2017 08:00:46 AM

The main hope of ICH Q8-Q10 pertaining to operational excellence is to enable (bio)pharmaceutical companies to achieve product realization. The goal is to do so by establishing and maintaining a state of control and facilitating continual i ...

Novel therapies for multidrug-resistant bacteria

12/05/2017 07:30:21 AM

Scientists at the University of Surrey in collaboration with research partners at the University of Sheffield and University of Würzburg, Germany, have developed novel antimicrobials, which could be used to treat infections, caused by mult ...

EMA expands list of excipients that must be disclosed

12/04/2017 08:00:22 AM

The EMA has expanded the list of excipients that drug firms must declare on product labels in a bid to address safety concerns about undeclared components.For further details see: In-PharmatechnologistPosted by Dr. Tim SandlePharmaceutical ...

How much does life weigh?

12/03/2017 07:30:07 AM

From earthworms and sunflowers to human beings, we are all made up of cells, so it's no surprise that researchers are hard at work investigating these building blocks of life. They have already discovered many of their secrets, but until now, ...

Mechanism bacteria use to attach to surfaces

12/02/2017 06:00:19 AM

In the article, "Obstruction of Pilus Retraction Stimulates Bacterial Surface Sensing," a group of interdisciplinary researchers show that in the case of the bacterium Caulobacter crescentus, a model organism that splits its life between swimming ...

Alternative antimicrobial compounds from wastewater

12/01/2017 07:00:24 AM

Biosurfactants are compounds produced naturally by bacteria, fungi or yeasts and they have been commercially utilised in shampoos, shower gels, and household cleaning products. They are also used in food, agriculture, cosmetic and medical industries ...

Hand surgeons provide update on wild animal bites

11/30/2017 06:30:22 AM

The article was prompted by the authors' experience in treating an elderly man who developed a progressive infection of the hand after being bitten on the finger by an opossum. The patient recovered after hospitalization including treatment ...

Bacteria Have a Sense of Touch

11/29/2017 06:30:15 AM

Bacteria may not have a central or sensory nervous system as we know it, but they can still physically "feel" the world around them, according to a new study.By MICHELLE STARRIt turns out the tiny microorganisms don't just respond to chemical ...

Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers

11/29/2017 02:45:04 AM

Did you realize that 90 percent of quality control microbiology remains reliant upon culture-based methods? Taking this fact into account, Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers serves ...

Role of gut microbiome in posttraumatic stress disorder

11/28/2017 08:00:23 AM

PTSD is a serious psychiatric disorder that can develop after a person experiences a life-threatening trauma. However, not everyone exposed to a traumatic event will develop PTSD, and several factors influence an individual's susceptibility, ...

Risk Based Approach to Environmental Monitoring (webinar)

11/27/2017 17:44:05 PM

Regulators frequently cite concerns with environmental monitoring and the lack of a well-thought out rationale. This shortfall can be overcome through the application of risk assessment and scientific approaches. The application of risk assessment ...

The people factor: investigating the gown

11/27/2017 07:00:26 AM

An effective environmental monitoring programme is designed to estimate the microbial content of the room air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within ...

Side-effect after antibiotics

11/26/2017 08:00:06 AM

Some bacteria are sensitive to penicillin, others are not. While patients swallow antibiotics to destroy harmful microorganisms, their own intestinal microbiota suffers changes. If the introduced unbalance leads to an overgrowth of bacteria ...

Hacking the bacterial social network

11/25/2017 07:00:00 AM

Scientists have determined the molecular structures of a highly specialized set of proteins that are used by a strain of E. coli bacteria to communicate and defend their turf.Whenever we use our smartphones to check social media, we face loads ...

Technical Guide for Design, Control and Monitoring of Single-Use Systems

11/24/2017 08:00:22 AM

The Bio-Process Systems Alliance (BPSA) announced today that its new technical guide to Design, Control and Monitoring of Single-Use Systems for Integrity Assurance is now available for download at http://bpsalliance.org/technical-guides.The ...

PHENOGENETIC MAP CREATED FOR STEM CELLS MODELS

11/23/2017 08:00:01 AM

In an effort to better understand neurological diseases like Alzheimer’s, Parkinson’s and ALS – and develop new ways to treat them – researchers at The Ohio State University Wexner Medical Center have performed the first meta-analysis ...

Justification of starting materials for the manufacture of chemical active substances

11/22/2017 07:30:10 AM

Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substancesThe EMA has revised and re-issued its reflection paper on API starting materials in order to further ...

Q&A production of water for injections by non-distillation methods

11/21/2017 07:00:27 AM

Q&A production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies – a new document of interest from the European Medicines Agency.The document states: “Production of water for injection ...

Cleanroom Management in Pharmaceuticals and Healthcare - special offer

11/20/2017 16:56:07 PM

Dear Reader,Euromed Communications have recently brought out a new 2017 edition of the Cleanroom Management in Pharmaceuticals and Healthcare. Since the first edition of this book in 2013 there have been many changes to the approach and methods ...

Microbial Control of Pharmaceutical Water Systems

11/20/2017 07:00:12 AM

Tim Sandle has written an article for Pharmaceutical Engineering:Water needs to be microbiologicallycontrolled. Microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. An out-of-control water ...

Biocidal cleaners may spread multidrug resistance in MRSA

11/19/2017 06:30:23 AM

Multidrug resistance to MRSA and reinfection with MRSA, said corresponding author Jonathan Shahbazian, MPH, were the most important in this study. The study also showed that whether used in humans or companion animals, the antibiotic clindamycin ...

Examining the lifestyles of microbes

11/18/2017 08:00:00 AM

Scientists are identifying and characterizing more microbes each year using DNA sequencing technologies. As each new species is sequenced, scientists add it to the microbial "tree of life," creating a virtual census of what's there.Turns out ...

Bacterial signalling in sharper resolution

11/17/2017 08:00:12 AM

The complex signalling networks bacteria use to adapt to their environments have become clearer following new research.John Innes Centre researchers used a study of the plant-growth promoting bacterium Pseudomonas fluorescens to develop an advanced ...

ISO/IEC 17025 moves to final stage of revision

11/16/2017 07:30:20 AM

Calibration as well as testing and analysing a sample is the daily practice of more than 60 000 laboratories worldwide, but how can they reassure customers about the reliability of their results?Over the years, ISO/IEC 17025, General requirements ...

Past, present, and future perspectives on the LAL reagent

11/15/2017 06:00:14 AM

Q&A covering past, present, and future perspectives on the LAL reagentFrom American Pharmaceutical Review:Since the introduction of the LAL reagent roughly 50 years ago, three methods of testing have been primarily used. how has your company ...

FDA approves first ever ‘digital pill’

11/14/2017 14:36:34 PM

An innovative medical device, in the form of a pill containing a built-in sensor has been developed and been given approval, based on safety and efficacy data, by U.S. authorities.by Tim SandleWhat is being heralded as the world’s first ...

How Staph Cells Dodge the Body’s Immune System

11/14/2017 07:30:09 AM

For years, medical investigators have tried and failed to develop vaccines for a type of staph bacteria  associated with the deadly superbug MRSA. But a new study by Cedars-Sinai investigators shows how staph cells evade the body’s immune ...

Antimicrobial copper surfaces in hospitals

11/13/2017 07:00:00 AM

Infection control in hospitals is of paramount importance in order to reduce the potential for healthcare associated infections (an infection whose development is favored by a healthcare environment.) Infection control is concerned with eliminating ...

Millions of new genes in human microbiome

11/12/2017 08:00:28 AM

A new study of the human microbiome has uncovered millions of previously unknown genes from microbial communities in the human gut, skin, mouth, and vaginal microbiome, allowing for new insights into the role these microbes play in human health ...

Imagining a world without species

11/11/2017 06:30:01 AM

Categorizing species can get especially hazy at small, microbial scales. After all, the classical definition of species as interbreeding individuals with sexually viable offspring doesn't apply to asexual organisms. Examining shared DNA doesn't ...

Antibiotic Alternative Micreos wins Most Impactful Innovation

11/09/2017 07:30:05 AM

In the presence of former UN-Secretary-General Kofi Annan and Dutch minister Melanie Schultz of Infrastructure & the Environment, Micreos' alternative to antibiotics was chosen as the most impactful innovation of The Netherlands. Micreos will ...

Ensuring Product Safety & Effectiveness

11/08/2017 17:17:12 PM

The Role of Pharmaceutical Quality Assurance in Ensuring Product Safety & EffectivenessQuality Assurance – A Systematic Approach to Overcoming the Surge of Substandard Medical Products by Edward SimpsonQuality assurance entails all the a ...

OptiBiotix moves into gut-brain axis area with ‘psychobiotics’

11/08/2017 07:30:10 AM

OptiBiotix, a world leader in microbiome modulation, has made a move into an exciting area of microbiome research, the gut-brain axis. The Company has signed an agreement with Taiwan-based Bened Biomedical Ltd., a leading Asian probiotic research ...

Thank you to Rapid Micro Biosystems

11/07/2017 14:35:53 PM

Rapid Micro Biosystems has been involved with the Pharmaceutical Microbiology Resources website and the Pharmaceutical Microbiology LinkedIn Group since the early days. These sites have helped to promote the concept of rapid microbiological ...

Birth of Marie Curie, sesquicentennial (1867)

11/07/2017 07:00:07 AM

No doubt the most famous Polish-born scientist since Copernicus, Curie was born in Warsaw on November 7, 1867, as Maria Sklodowska. Challenged by poverty, family tragedies and poor health, she nevertheless excelled as a high school student. ...

The future possibilities of graphene for microbiology

11/06/2017 07:30:01 AM

Graphene is the most widely researched new material. It is an allotrope of carbon and due to special properties the material is being tested out within the fields of consumer and medicinal electronics. While these applications have received ...

EDQM: Microbiological control symposium

11/05/2017 13:16:59 PM

A symposium on microbiology in the pharmaceutical sector was the opportunity for the EDQM to gather feedback from users of the European Pharmacopoeia on alternative testing methods for microbiological control and sterilisation processes. The ...

New drug effective against malaria

11/05/2017 07:00:13 AM

Researchers have developed a new drug that is effective against non-severe cases of malaria, according to results from an FDA-supervised clinical trial. The results are significant as public health experts have long warned that the parasite ...

Therapies to Combat Zika Virus

11/04/2017 07:30:12 AM

After the declaration of the Zika epidemic as an international public health emergency by WHO in February 2016, research on Zika Virus (ZIKV) has increased several folds. Previously, ZIKV, a mosquito borne virus, was considered to induce only ...

Interventions to influence antibiotic prescribing behavior

11/03/2017 08:00:02 AM

A new review, ‘Clinician-targeted interventions to influence antibiotic prescribing behaviour for acute respiratory infections in primary care’ published on September 7, 2017 in the Cochrane Database of Systematic Reviews.An overview of ...

What the FDA Guidance on Data Integrity Means for Your Lab

11/02/2017 08:30:03 AM

Dale Curtis Jr. is the President of Astrix Technology Group has written a review of data integrity requirements for the laboratory. Here is an extract:“Data integrity is the maintenance and assurance of the accuracy and consistency of data ...

Biocontamination control for cleanrooms - prEN 17141:2017

11/01/2017 06:30:03 AM

A new European cleanroom standard is in the early stages development: “Cleanrooms and associated controlled environments - Biocontamination control” prEN 17141:2017.The scope is: “This European Standard establishes the principles and basic ...

Drug Quality and Security Act and overseeing the safety of compounded drugs

10/31/2017 08:30:20 AM

In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It ...

Review of MHRA GMP deficiencies

10/30/2017 09:00:00 AM

Tim Sandle has written a review for GMP Review looking at recent MHRA inspectorate findings relating to sterility assurance.Reading and reviewing findings from regulatory inspections can help an organisation to develop best practices and to ...

HEPA Versus ULPA

10/29/2017 07:30:14 AM

There are two primary types of air filters used in BSCs: HEPA (High Efficiency Particulate Air), and ULPA, (Ultra-Low Particulate Air). Understanding the similarities and differences between HEPA and ULPA aids in selecting the filter which offers ...

World Stroke Day

10/28/2017 17:00:03 PM

October 29 is World Stroke Day, a time to spotlight the deadly condition, warning signs and how to prevent it. AliveCor, the creator of Kardia Mobile, a smartphone device that lets people like you and me get a full-picture of our heart health ...

Pharmaceutical Microbiology Book

10/27/2017 08:00:00 AM

Pharmaceutical MicrobiologyPharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting ...

Theory and Practice of Disease Diagnosis

10/26/2017 14:16:06 PM

A new book of interest:The book provides theoretical and practical information for diseases diagnosis. It is a collaborative book to support IP Erasmus project MDHP, with partners from different countries from Europe. Thebook includes chapters ...

Pharmaceutical Microbiology: Current and Future Challenges

10/25/2017 08:00:16 AM

To meet regulatory expectations, the role of the microbiologist is essential. To add to this, the input from quality assurance personnel, engineers, and process specialists is required. Whilst there is a continuing need for monitoring of the ...

50+ FDA acronyms that matter to your business

10/24/2017 06:30:17 AM

The Vaisala Measurement & Monitoring Program is offering a list of useful FDA acronyms. For further details see: Vaisala.Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com

Assessment of Bacterial Endotoxin by Fluorescent Labeling

10/23/2017 08:00:11 AM

Tim Sandle has written a review of a new range of development tests that can detect bacterial species based on analysis of endotoxin. The review is published in American Pharmaceutical Review.New research in the field of bacterial endotoxin ...

An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments

10/22/2017 08:23:47 AM

Crystal Booth has written a useful article for Pharmaceutical Online looking at environmental monitoring and disinfection of aseptic processing environments. Here is an extract:“Microbial control is critical in cleanroom environments. Contaminated ...

Smartphone screen technology used to trick harmful bacteria

10/21/2017 07:30:02 AM

Conducting plastics found in smartphone screens can be used to trick the metabolism of pathogenic bacteria, report scientists. By adding or removing electrons from the plastic surface, bacteria may be tricked into growing more or less. The method ...

Puerto Ricans Suffer Drug Shortages After Hurricane Maria

10/20/2017 18:40:01 PM

Pharma Industry of Puerto RicoThe pharmaceutical industry of Puerto Rico is, well, huge. In 2016, nearly three-quarters of the island’s exports were pharmaceuticals, with a total value of $14.5 billion USD.A special guest post by Megan Ray ...

Bacterial in-fighting provides new treatment for hospital infections

10/20/2017 07:30:22 AM

A bacteria that is a leading cause of death worldwide from hospital acquired infections following antibiotic treatment looks set to be brought down through its own sibling rivalry. New research from the University of Sheffield shows that Different ...

Cilia: 'The bouncer' of bacteria

10/19/2017 07:00:20 AM

A new paper, from University of Southern California, elucidates the active role of cilia in regulating flow for bacteria filtering and enhancing chemical communication.The paper, published in the Proceedings of the National Academy of Sciences, ...

Microbiologist Wins International Prize for Biology

10/18/2017 08:00:05 AM

Rita Colwell, a Distinguished University Professor in the University of Maryland Institute for Advanced Computer Studies, has been named the 2017 laureate of the International Prize for Biology for her outstanding contributions to marine mi ...

How Listeria monocytogenes can survive in extreme environmental conditions

10/17/2017 07:30:17 AM

It is difficult to eliminate L. monocytogenes from post processing contamination of food production lines since this pathogen is common in various environments outside processing plants, and can endure in food processing environments. Listeria ...

New standards for cleanroom construction

10/16/2017 07:00:19 AM

Tim Sandle has written a new article for Cleanroom Technology around the subject of cleanroom construction. A new part of ISO 14644 – part 14 – came out last year which covers cleanroom equipment specification. Tim Sandle looks at why it ...

Solutions for the automated infeed and loading of medical products

10/15/2017 06:00:23 AM

Wolfertschwenden– Presentations from MULTIVAC at this year's Compamed will include solutions for the automated infeed and loading of medical products within the packaging procedure. In addition to a syringe infeed system for loading ...

Klebsiella species share drug resistance genes

10/14/2017 07:30:27 AM

Three different species of Klebsiella bacteriacan cause life-threatening infections in hospital patients and that all three share genes that confer resistance to the most commonly used antibiotics, new research shows. The study improves physicians' ...

WHO Specifications for Pharmaceutical Preparations

10/13/2017 07:00:14 AM

The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations meets now annually and their reports (Technical Report Series) include all adopted guidelines in the form of Annexes. The 51streport has now ...

Microbial Identification strategy for pharmaceutical microbiology

10/12/2017 08:00:03 AM

Microbial identification represents an important part of the microbiology function. This includes screening products for objectionable organisms, profiling the environmental microbiota, and investigating out-of-limits events with a view to assigning ...

A new estimate of biodiversity on Earth

10/11/2017 07:30:30 AM

To date, about 1.5 million species have been formally described in the scientific literature, most of them insects. Proportionally, bacteria comprise less than 1% of all described species.Scientists generally agree that many more species exist ...

A Guide to Applying the Four Pillars of ICH Q10

10/10/2017 06:00:04 AM

A white paper of interest from Pharmaceutical Manufacturing:This White Paper will detail not only the applications of the four pillars and their corresponding QMS applications, but also additional QMS functions that help to ensure ICH Q10 c ...

Sterilization: Practical Approaches

10/09/2017 07:30:00 AM

A new e-book has been published: Sterilization: Practical Approaches offers practical approaches to sterility testing, Gamma Irradiation for single use disposables, sterilization using EtO and dry heat, ophthalmic preparations and contamination ...

Digital colony counters making microbiology easier

10/08/2017 07:30:22 AM

For microbiologists the process of counting bacterial colonies can be tedious and mistakes can happen. Laboratory managers are turning attention to automated, digital devices to streamline processes.Technology review by Tim SandleThe ‘lean’ ...

Understanding Biosafety Levels

10/07/2017 07:00:11 AM

The handling of any biological agent requires an understanding of the agent and the risk of exposure to personnel, the facility, and the environment. The U.S. CDC and the NIH have used risk assessment to develop four ascending biosafety levels ...

Europe and U.S. Regulators Increase Cooperation on Inspections

10/06/2017 07:00:08 AM

The European Commission, the FDA, and the European Medicines Agency (EMA) have signed a new confidentiality agreement that allows regulators on both sides of the Atlantic to share non-public and commercially confidential information, including ...

Epigenetic drugs show promise as antivirals

10/05/2017 08:00:03 AM

Some epigenetic pharmaceuticals have the potential to be used as broad spectrum antivirals, according to a new study. The study demonstrated that histone methyltransferases EZH2/1 inhibitors, which are being used in cancer clinical trials, have ...

Matrix Approach for the Qualification of a Pharmaceutical Facility Autoclave

10/04/2017 07:30:12 AM

The validation and verification of the sterilization process requires careful planning, and this includes selection of the loads (pre-defined configurations of items to be sterilized). For the validation or qualification approach different ...

Understanding antibiotic resistance

10/03/2017 07:30:25 AM

Researchers have uncovered new insights into how bacteria respond to stress. When deprived of nutrients, strains of the bacterium Streptococcus pneumoniae mount a coordinated defense. When exposed to antibiotics, the bacterial response is highly ...

Sterilization: Establishing the Process

10/02/2017 08:00:09 AM

A new e-book has been published: Sterilization: Establishing the Process discusses compliance, regulatory inspections, containment system sterility, test failure investigations and many other basics.The content is:Compliance Aspects of Sterility ...

The Internet of Things (IoT) Within The Laboratory

10/01/2017 08:00:07 AM

Getting real value out of IoT it can be viewed as a ‘perfect storm’ in the sense that it presents “a rare combination of circumstances with the potential to result in an event of unusual magnitude.” IoT can be defined as physical objects ...

Fungi are key players of the deep biosphere

09/30/2017 07:30:09 AM

In addition to the life on the surface of Earth and in its oceans, ecosystems have evolved deep under us in a realm coined the "deep biosphere" which stretches several kilometers down into the bedrock. Down there, the conditions are harsh and ...

Study contradicts widely held belief on length of antibiotics use

09/29/2017 07:30:13 AM

A new study emerged, published in the BMJ has countered this by suggesting that this direction is not based on evidence.The study actively argues against the “complete the course” mantra, suggesting that patients should instead stop taking ...

Bacteria busting detergent

09/28/2017 07:00:27 AM

Advertorial:There seems to be no shortage of ways to stay fresh and clean these days—in recent news, everything from MIT biofabrics that leverage living bacteria, to T-shirts made from coffee beans, are claiming to answer the ever-growing ...

Yeast helps hunt for new medicines

09/27/2017 07:00:03 AM

Scientists have developed a new way to predict potentially useful drugs from a pool of undefined chemicals. They were able to more quickly identify leads that could be used to treat a range of diseases, from infections, to cancer to Alzheimer's. ...

Written procedures for new applicants for Wholesale Dealer Authorisations

09/26/2017 07:30:23 AM

The MHRA blog contains an article of interest for those involved with regulatory activities. The blog is titled “Creating written procedures for new applicants for Wholesale Dealer Authorisations (WDA)”, and it is written by Steve Todd. ...

Community acquired pneumonia in children

09/25/2017 08:00:00 AM

Pneumonia in children of all age groups has a strong association with morbidity. This highlights the importance of studying the clinical and diagnostic aspects of community-acquired pneumonia. For those suffering from pneumonia, general biological ...

How bacteria maintain and recover their shape

09/24/2017 07:30:15 AM

Bacteria have an extraordinary ability to maintain and recover their morphology even after being twisted out of shape. Shape plays an important role in how bacteria infiltrate and attack cells in the body. The helical shape of Helicobacter pylori, ...

How S. aureus spreads resistance to antibiotics

09/23/2017 08:00:19 AM

Infection by S. aureus is a serious threat in hospitals worldwide. Now, scientists have identified a key component of the machinery that allows Staphylococcus aureus to transfer genes that confer antibiotic resistance. Halting the spread of ...

Key Factors for Producing Error Free Pharma Packaging

09/22/2017 07:30:10 AM

The pharmaceutical industry stands for one of the fastest growing and the most profitable industries in the world. An increase in sales and growth of the work amount, apart from the high profit, can bring some unwanted problems and challenges ...

Analysis Of FDA Warning Letters

09/21/2017 07:30:04 AM

Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. This is the focus of a review of FDA warning letters and data integrity concerns, conducted by Barbara Unger, ...

Cases of superbug Clostridium difficile increase

09/20/2017 13:40:17 PM

The most troubling cases of C. difficile infection, termed multiple recurring C. difficile infections (mrCDI), are becoming more common, according to a new university research study.The study comes from the University of Pennsylvania School ...

GLP Inspections metrics reflections

09/19/2017 14:10:13 PM

An MHRA blog post by Martin Reed looks at collation of the 2015 inspection metrics data.According to Reed, these data have "highlighted some common themes which I am going to illustrate by sharing some examples with you. All of the situations ...

Design and control of pharmaceutical water systems

09/18/2017 08:00:04 AM

Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, an out-of-control water system can cause harm to the patient or adulterate pharmaceutical products. Purification ...

Magnetized viruses attack harmful bacteria

09/17/2017 08:00:04 AM

Antibacterial phages combined with magnetic nanoparticle clusters effectively kill infectious bacteria found in water treatment systems. A weak magnetic field draws the clusters into biofilms that protect the bacteria and break them up so the ...

Plan for the introduction of the safety features on medicinal packaging

09/16/2017 08:00:03 AM

The European Medicines Agency (EMA) has issued a new guidance document titled “Implementation plan for the introduction of the safety features on the packaging of centrally authorized medicinal products for human use.”Certain aspects of ...

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