Considerations of melanocytic nevi in children

A paper of interest:

The incidence of melanocytic nevi is increasing, and nevocytic nevi are commonly encountered in childhood. Therefore, the study of these tumors, particularly those that are likely to become malignant, represents an important issue. This paper presents clinical, statistic and structural data on the melanocytic nevi in children, and of adjacent areas when the nevi were surgically excised. The study was made possible by collaboration with the specialty medical stuff of Children Clinic Hospital Braşov. The analysis of the melanocytic nevi was retrospective in relation to 30 patients. These cases were selected from the cases investigated in the first half of 2013. The pathological anatomy diagnosis was conducted following a biopsy of the fragments of melanocytic nevi excised by surgery. This took place within the plastic surgery department of the Children Clinic Hospital Brasov.

The reference is:

Cheşcă, A., Luculescu, M.C., Sandle, T. (2015) Considerations of melanocytic nevi in children, Annals of the Romanian Society for Cell Biology, 19 (2): 19 - 22 doi: 10.ANN/RSCB-2015-0001:RSCB

The paper can be accessed here.

Posted by Tim Sandle

Patterns of microbial diversification

James O'Dwyer  (Carl R. Woese Institute for Genomic Biology) has produced a series of microbial family trees with distinct evolutionary patterns. He has sorted sequence data into a new kind of family tree (phylogenetic tree) that displays patterns of diversification. Diversification includes 22 microbial communities, chosen to represent a breadth of habitat types: plant, marine, and human gut and skin.

For further details see:

James P. O’Dwyer, Steven W. Kembel, Thomas J. Sharpton. Backbones of evolutionary history test biodiversity theory for microbes. Proceedings of the National Academy of Sciences, 2015; 112 (27): 8356 DOI: 10.1073/pnas.1419341112

Posted by Tim Sandle

Free webinar on ISO 14698

ISO 14698: Learn about general principles and methods of biocontamination control in cleanrooms according this ISO norm and also about the validation of an agar plate active microbial air sampler.

The ISO 14698 part of the webinar is led by Dr Tim Sandle

The air-sampler validation part is led by Anne Connors, Field Marketing Manager, Merck Millipore.

The webinar will allow time for questions.

To sign-up for the event, see Merck Millipore.

REGISTER TODAY!

Live webinar on the validation of an agar plate active microbial air sampler according to ISO 14698

Posted by Tim Sandle

Nanoscale antimicrobials

North Carolina State University researchers have developed an effective and environmentally benign method to combat bacteria by engineering nanoscale particles that add the antimicrobial potency of silver to a core of lignin, a ubiquitous substance found in all plant cells. The findings introduce ideas for better, greener and safer nanotechnology and could lead to enhanced efficiency of antimicrobial products used in agriculture and personal care.

In a study published in Nature Nanotechnology, NC State engineer Orlin Velev and colleagues show that silver-ion infused lignin nanoparticles, which are coated with a charged polymer layer that helps them adhere to the target microbes, effectively kill a broad swath of bacteria, including E. coli and other harmful microorganisms.

As the nanoparticles wipe out the targeted bacteria, they become depleted of silver. The remaining particles degrade easily after disposal because of their biocompatible lignin core, limiting the risk to the environment.

The researchers used the nanoparticles to attack Escherichia coli, a bacterium that causes food poisoning; Pseudomonas aeruginosa, a common disease-causing bacterium; Ralstonia, a genus of bacteria containing numerous soil-borne pathogen species; and Staphylococcus epidermis, a bacterium that can cause harmful biofilms on plastics — like catheters — in the human body. The nanoparticles were effective against all the bacteria.

For further details see “An environmentally benign antimicrobial nanoparticle based on a silver-infused lignin core” - Nature Nanotechnology (2015)DOI: doi:10.1038/nnano.2015.141

Posted by Tim Sandle

Antimicrobial copper delivers safer healthcare to South Africa's remote villages

South Africa’s so-called ‘Miracle Trains’ – Transnet’s Phelophepa I and II, which provide healthcare to rural communities across the country – have harnessed the antimicrobial copper to help deliver safer healthcare to millions of people.

The 18-coach trains travel for 35 to 36 weeks of each year, visiting a different community every one to two weeks, and with more than 300,000 people using the facilities annually, infection prevention is a high priority. Consequently, they have been equipped with bacteria-killing antimicrobial copper door handles to help provide a more hygienic environment for patients and staff.

Antimicrobial copper cupboard doors will soon be added to the kitchen facilities, and plans are also underway to install antimicrobial copper table tops in some of the clinics.

As reported by Cleanroom Technology. For further details see: CT.

Posted by Tim Sandle

EMA consults on antibiotics and farm animals

The European Medicines Agency is currently running an important public consultation on how best to assess the risks of antimicrobial resistance passing from food animals to human. The consultation is open until 31st August.

Draft guidelines have been prepared which are designed to help regulators assess the risks associated with individual antimicrobials when they are licensed or their licenses are reviewed.

There are several associated concerns, as previously reported. These include risks to human health (some of the antibiotics used on farm animals could cause harm.) A second reason is that the use of such antibiotics unnecessary promotes antibiotic resistance among certain types of bacteria, especially given that the administration cannot be securely controlled in relation to the external environment.

A third concern is that farm workers can become exposed to antibiotic resistant strains of bacteria, especially via the nose, and that these can be taken by the farm workers home to the their families.

The consultation is based around a draft paper "Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food producing animals."

Posted by Tim Sandle

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH has issued a final version of its questions and answers relating to ICH Q7. According to ICH:

“The Guideline reached Step 4 of the ICH process on June 2015. Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.”

To access the document, go to: ICH.

Posted by Tim Sandle

FDA guidance on Size, Shape, and Other Physical Attributes of Generic Tablets

FDA has issued final guidance regarding Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.

The guidance is intended to address concerns that differences in size, shape, and other physical characteristics between generic tablets/capsules and the reference listed (brand) drug (“RLD”) may affect patient compliance and acceptability of medication regimens or could lead to medication errors.

According to the guidance:

“While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.”

To access the guidance, see FDA

Posted by Tim Sandle

FDA draft guidance on injectable volume excess

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance document. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.

The guidance can be accessed here: FDA

Posted by Tim Sandle

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

This book provides pharmaceutical microbiologists with everything they need to know, from regulatory filing and GMP information, to laboratory design and management, compendia tests, and the risk assessment tools and techniques for both sterile and non-sterile products.

Pharmaceutical Microbiology by Tim Sandle

Posted by Tim Sandle

Cleanroom Microbiology Book

Cleanroom Microbiology by Tim Sandle - for a copy, see PDA

Posted by Tim Sandle

Guidance for importers of medicinal products

The European Medicines Agency has issued a new concept paper “Guidance for importers of medicinal products.”

The paper poses and addresses the following problem statement:

“The increased complexity of supply chains and the observation that most GMP non-compliance statements uploaded into EudraGMDP pertain to third country manufacturers have created new areas where further guidance is desired by both the regulators and the industry. In particular, the requirements applicable to importers of medicinal products and concerning the application of GMP requirements, which are traditionally oriented to activities performed at true manufacturing sites.”

To review the paper, go to EMA.

Posted by Tim Sandle

FDA Releases Isolate-Level Data for Common Gut Bacteria

FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS).

For more details see: Regulatory Affairs Professionals Society

Posted by Tim Sandle

New links between gut microbes and mental health in children

Interesting microbiome news from Genscript:

As we learn more about the human microbiome, evidence keeps mounting that the 'Gut-Brain Axis' enables our intestinal bacteria to influence our mood and mental health:

•	A recent study in Brain, Behavior, and Immunity finds that differences in gut microbiome composition are associated with differences in temperament in healthy toddlers.
•	A new study in Pediatric Research finds an association between early probiotic intervention and the risk of neuropsychiatric disorders (ADHD and Asperger syndrome) later in childhood.
•	A new review discusses new evidence from epidemiology an animal studies on bidirectionality of gut-brain communication across development and efforts to prevent or treat psychological disorders by modifying intestinal flora.

Posted by Tim Sandle

Road Map for Addressing Quality and Manufacturing Challenges

The primary difficulty pharmaceutical companies are forced to grapple with is how to accelerate the time it takes for a product to get from R&D to patients in need. In an effort to face this challenge, prominent pharmaceutical companies are placing increased emphasis on manufacturing and quality management improvements. In fact, most pharmaceutical manufacturers are finding that a holistic, comprehensive approach to quality can transform a company’s quality management system (QMS) from a burdensome necessity to a competitive advantage. To help you achieve similar goals, LNS Research has produced a free, comprehensive eBook that serves as a guide through the numerous impediments your company deals with every day in the struggle to manage an efficient and compliant quality system.

To address these issues, LNS Research has put together an eBook. To access the book, go to: Road Map.

Posted by Tim Sandle

Identification of anaerobic Actinomyces species

Public health England has issued “UK Standards for Microbiology Investigations ID 15: identification of anaerobic Actinomyces species.”

The genus Actinomyces currently contains 46 species and two subspecies that have been characterised by phenotypic and molecular methods1. Twenty four of these species are associated with humans and five have been recently assigned to other genera. The genus comprises 17 species that are known to be the cause of a wide spectrum of clinical diseases in animals.

The document provides guidance about the identification of these organisms. To access the document, see Public Health England.

Posted by Tim Sandle

Hospital tap water scheme

Tap water in hospitals can be an area of microbiological contamination, if not correctly controlled. Public Health England has issued guidance for testing.

The guidance is titled “Hospital tap water scheme: intended results for distribution HTW4.” The document states: “This external quality assessment (EQA) scheme is particularly suited to laboratories in the water testing and clinical microbiology sectors that examine hospital tap waters.” The examination covered refers to Pseudomonas aeruginosa.

To access the document, see Public Health England.

Posted by Tim Sandle

Pollutants: do they contribute to an increase in antibiotic resistance genes?

Maintaining resistance plasmids in bacteria generally requires a strong selective pressure such as a high concentration of an antibiotic. But new research by Gullberg et al. suggests that these selective pressures do not need to be strong to be effective; antibiotics and heavy metals at very low levels are sufficient to maintain a multiresistance plasmid. This could have serious implications for how environmental pollution and antibiotic treatment affect development of drug resistance.

Further details have been posted by PCR Pathways

Posted by Tim Sandle

FDA opens up review into hand disinfectants

There is a vast array of different products on the market. Few are manufactured and sold specifically for pharmaceuticals; most are developed for the healthcare sector and sold across both healthcare and pharmaceuticals. Generally, given the similarity in disinfectant efficacy testing standards, the cross use of such products is not problematic with the exception that products used in higher grade pharmaceutical cleanrooms need to be sterile. Although many products are available, the US Food and Drug Administration (FDA) is concerned about their effectiveness and the federal agency has opened a review in relation to healthcare use.

Because of the cross marketing and limited range of active ingredients in such products, this review will cut across the pharmaceutical sector. The use of hand disinfectants embraces a number of GMP concerns.

In light of this, Tim Sandle has written an article about the review and the implications for the pharmaceutical sector. The article is published in the GMP Review.

The reference is:

Sandle, T. (2015) FDA opens up review into hand disinfectants, GMP Review, 14 (2): 8-9

If you would like to review a copy, please contact Tim Sandle

Posted by Tim Sandle

Emerging Methods for Virus Detection

A new publication of interest - PDA Technical Report No. 71 (TR 71) Emerging Methods for Virus Detection

The report describes and critically assesses methods currently used for the detection of potential adventitious viruses in biomedicinal products or their production processes.

Although current methods for detecting adventitious viruses have provided a generally good safety record of biological medicines over the years, these methods may not detect latent or occult viruses, novel viruses, and even some known viruses. Emerging nucleic-based methods have demonstrated the potential to fill these gaps for virus detection.

This Technical Report details and discusses new methods that have been recently developed as a result of technological advances in molecular biology, mass spectrometry and genomics, that offer the potential for known and novel virus detection.

For further details, see: PDA

Posted by Tim Sandle

Hijacked Journals

Interesting post via Scholarly Open Access

Sometimes someone will create a counterfeit website that pretends to be the website of a legitimate scholarly journal. The website creators then solicit manuscript submissions for the hijacked version of the journal, pocketing the money. In some cases the legitimate versions of the journals are only published in print form and they may not have websites.

In the table below, the hijacked journal is listed in the left column; the corresponding authentic version of the journal is on the right. In cases where no website can be found for the original journal, a link is made to a bibliographic record for the journal.

Hijacked Journal	Authentic Journal
ACADEMIE ROYALE DES SCIENCES D OUTRE-MER BULLETIN DES SEANCES	Bulletin des séances- Académie royale des sciences d’outre-mer
Afinidad	Afinidad
AGROCHIMICA	Agrochimica
Anais da Academia Brasileira de Ciências	Anais da Academia Brasileira de Ciências
Anare Research Notes	ANARE Research Notes
Archives des Sciences	Archives des Sciences
Aula Orientalis	Aula Orientalis
Ayer Also here	Ayer: Revista de Historia Contemporánea
Baltica Journal	Baltica
BEITRAEGE ZUM NATURSCHUTZ IN DER SCHWEIZ(Switzerland Nature)	Beiträge zum Naturschutz in der Schweiz
Bothalia Journal	Bothalia – African Biodiversity & Conservation
Bradleya	Bradleya
CADMO JOURNAL	CADMO
Cahiers des sciences naturelles	Les cahiers des sciences naturelles
CAHIERS DE PAIOLIVE	Les Cahiers de Païolive
Chemical and Process Engineering	Chemical and Process Engineering
Chemical Modelling Journal	Chemical Modelling: Applications and Theory
Ciência e técnica	Ciência e técnica vitivinícola
Comptes rendus de l’Académie bulgare des Sciences	Comptes rendus de l’Académie bulgare des Sciences
Contributions in Science	Contributions in Science
Doriana	Doriana : supplemento agli Annali del Museo civico di storia naturale “G. Doria.”
DU Journal Published By Verlad Niggli AG (VNA)	Du
Education Journal	Education
Emergencias	Emergencias
Ephemera Also here.	Ephemera: revue d’éphéméroptérologie
Epistemologia	Epistemologia
FABRERIES JOURNAL	Fabreries
FAUNA ROSSII I SOPREDEL NYKH STRAN	Fauna Rossii i sopredelʹnykh stran
FOURRAGES	Fourrages
GAIA-ATHENS Journal	Gaia
GAZI UNIVERTESI GAZI EGITIM FAKULTESI journal	Gazi University Journal of Gazi Educational Faculty
GMP Review	GMP Review
Hermes Journal France	Hermès
Hospital Materials Management	Hospital material$ management
Iheringia Série Botânica	Iheringia. Série botânica
Interciencia Association	Interciencia
International Review of Social Psychology	La Revue internationale de psychologie sociale
JOURNAL OF RENEWABLE NATURAL RESOURCES BHUTAN	Journal of renewable natural resources, Bhutan
Journal of Technology	Journal of Technology
Jokull Journal	Jökull
JNSS: Journal Namibia Scientific Society	Journal / Namibia Scientific Society
Kasmera Journal (Revista Kasmera)	Kasmera
LUDUS VITALIS	Ludus vitalis: revista de filosofía de las ciencias de la vida
MAGNT Research Report	MAGNT Research Report
Martinia	Martinia: bulletin de liaison des Odonatologues de France
MULTITEMAS	Multitemas
Nationalpark Berchtesgaden Forschungsbericht	Nationalpark Berchtesgaden: Forschungsberichte
Nationalpark-Forschung in der Schweiz	Nationalpark-Forschung in der Schweiz
Nautilus Journal	The Nautilus
Natura	Natura: orgaan der Nederlandsche Natuurhistorische Vereeniging
Mitteilungen Klosterneuburg	Mitteilungen Klosterneuburg
ODJELJENJA PRIRODNIKH NAUKA CRNOGORSKA AKADEMIJA NAUKA I UMJETNOSTI GLASNIK	Odjeljenje prirodnih nauka
Odonatological Abstract Service	Odonatological abstract service
OTECHESTVENNAYA ISTORIYA Journal	Российская история = Rossiĭskai︠a︡ istorii︠a︡
Pensee	La Pensée
PHILIPPINE SCIENTIST	Philippine scientist
PraeParator	Der Präparator
Reef Resources Assessment and Management Technical Paper	Reef resources assessment and management: technical paper
Research-Technology Management(Res Tech Manag)	Research-Technology Management(RTM)
REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES	Revue scientifique et technique
Saussurea	Saussurea, journal de la Société botanique de Genève
Scientia Guaianae	Scientia Guaianae : a series on natural sciences of the Guayana region
Scientific Khyber	Scientific khyber
Social Behavior and Personality: an international journal	Social Behavior and Personality: an international journal
Survey Methodology	Survey Methodology
Sylwan (English ed.)	Sylwan
Systems science journal	Systems science
TERAPEVTICHESKII ARKHIV	Terapevticheskiĭ arkhiv
TEKSTIL JOURNAL CROATIA	Tekstil
Veliger	The Veliger
VERIFICHE	Verifiche: Rivista di scienze umane
VITAE-REVISTA DE LA FACULTAD DE QUIMICA FARMACEUTICA	Vitae, la revista de la Facultad de Química Farmacéutica
Walia Journal	Walia, journal of the Ethiopian Wildlife and Natural History Society
WIWO Report	WIWO report
Wulfenia, Wulfenia	Wulfenia

Technical articles update

I've just updated the free technical articles available via this website, removing dead links and putting up some new content. Please feel free to visit.

Posted by Tim Sandle

Engineered Particles 'may become Antibiotics of the Future'

“Due to rising threat of antibiotic resistance, there is a pressing need for new approaches to fight harmful bacteria.” As reported via the Infectious Diseases Newsletter: “Now, researchers have been successful in developing engineered particles called "phagemids" that enter targeted harmful bacteria and release toxins that kill them. In a study, they developed a particle that works by targeting and killing specific bacteria without causing the cells to burst and release their toxins. These particles are "called phagemids" because they infect the target bacteria with plasmids.”

For further details, see Infectious Diseases.

Posted by Tim Sandle

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH has issued a final version of its questions and answers relating to ICH Q7. According to ICH:

“The Guideline reached Step 4 of the ICH process on June 2015. Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.”

To access the document, go to: ICH.

Posted by Tim Sandle

FDA guidance on Size, Shape, and Other Physical Attributes of Generic Tablets

FDA has issued final guidance regarding Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.

The guidance is intended to address concerns that differences in size, shape, and other physical characteristics between generic tablets/capsules and the reference listed (brand) drug (“RLD”) may affect patient compliance and acceptability of medication regimens or could lead to medication errors.

According to the guidance:

“While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.”

To access the guidance, see FDA



 Posted by Tim Sandle

Continuing Gaps in High-Risk Sterile Compounding Practices

Hospital and health-system pharmacists must ensure that both internal sterile compounding staff and external sterile compounding facilities meet high standards of practice to ensure patient safety, according to an article and accompanying editorial in the August 1 issue of AJHP. A national certification or credential to verify competence in sterile compounding personnel may be needed to achieve this goal on a broad scale, according to the editorial.

PRESS RELEASE

Ongoing, chronic national drug shortages are forcing hospitals to seek other sources for medications that meet patients’ clinical needs, including external compounding facilities. The AJHP editorial urges pharmacy managers and directors to ensure that the proper risk mitigation procedures are in place if they conduct their own compounding or outsource to a compounding facility. Pharmacy leaders also should evaluate the risks and benefits associated with switching to another commercially available product.

The editorial, which accompanies a practice report, “Laboratory Replication of Filtration Procedures Associated with Serratia Marcescens Bloodstream Infections in Patients Receiving Compounded Amino Acid Solutions,” recommends that administrators ensure the credibility of external compounding facilities before contracting with them.

The practice report details a March 2011 high-fatality outbreak of Serratia marcescens bloodstream infections at six Alabama hospitals among patients who had received total parenteral nutrition (TPN). Because the 15% amino acid solution used in the TPN was part of a national drug shortage, the hospitals had contracted with a compounding pharmacy to prepare and filter-sterilize their supplies.

Once the outbreak occurred, personnel from the Alabama Department of Public Health and the Centers for Disease Control and Prevention found a number of problems with the way the solution had been compounded. They identified deviations from USP chapter 797 standards, including the following:

• The compounded solution was allowed to sit for up to 48 hours before filtration.
• There was no use of a prefilter before use of the sterilizing filter, despite excessive particulate matter in the solution.
• Sterilizing filters were changed during filtration slowdown or clogging without replacing the entire tubing set.
• Insufficient volumes of postfiltration solution were used during sterility testing.

The investigating team also discovered that harmful bacteria were able to pass through 0.2- and 0.22-µm filters intended for sterilization of the amino acid solution. However, the bacteria did not pass through 0.2-µm filters when a USP-recommended 0.5-µm prefilter was used.

The creation of USP chapter 797 — a set of regulations that governs a wide range of pharmacy policies and procedures, including compounded sterile preparations — has reduced instances of preparation contamination, but many gaps still remain, according to the article authors.

The findings by study authors Heather Moulton-Meissner, Ph.D.; Judith Noble-Wang, Ph.D.; LCDR Neil Gupta, USPHS, M.D.; LCDR Susan Hocevar, USPHS, M.D.; CDR Alex Kallen, USPHS, M.D.; and Matthew Arduino, Dr.P.H., are critically important for patient safety, according to AJHP Editor in Chief Daniel Cobaugh, Pharm.D., FAACT, DABAT.

“Choosing to use an outside sterile compounding facility can reduce a pharmacist’s ability to directly ensure competence and diligence in preparing the medication,” Dr. Cobaugh said. “Pharmacists must be vigilant and knowledgeable when evaluating both the facility and the compounding processes that are used to ensure that risks are minimized.”

The editorial, authored by Ross W. Thompson, B.S.Pharm., M.S., FASHP, director of Pharmacy Services at Tufts Medical Center, and Caryn Belisle, B.S.Pharm., M.B.A., director of Pharmacy Regulatory Compliance, Quality, and Safety at Brigham and Women’s Hospital, notes that the pharmacy profession has no universal standard for establishing sterile compounding credentials or competency. The editorial goes on to state that “perhaps the time has come for the pharmacy profession to develop a nationally recognized certification or other credential to validate the expertise in the practice of sterile compounding.” 

Posted by Tim Sandle