Pharmig News

The latest edition of Pharmig News has been published (issue 52). The current issue includes a discussion about genotypic identification by Vikki Mitchell; the latest on the revision to the biocontamination standard ISO 14698; a regulatory update; details of Pharmig training courses…and more.

The newsletter has been sent to Pharmig members. Copies can be purchased via the Pharmig office, please contact: Pharmig

Posted by Tim Sandle

New 'defined' medium for Lactobacilli

Texas A&M University System scientists from the departments of nutrition and food science and poultry science have developed a new medium for the cultivation of lactobacilli.

Prior to the development of the new medium, the nutrient compositions of media that are traditionally used to cultivate lactobacilli have been largely undefined. This lack of definition complicates the use of media when trying to identify nutrients to stimulate the growth and metabolic activity of these important microorganisms.

To develop the new medium, the overall contribution of undefined components, such as peptone, yeast extract and beef extract, was reduced by 70 percent in the final formulation.

For further details, see the following research brief.

Posted by Tim Sandle

New ecological map of the human body

An interesting paper has been published in Nature by Keisha Findley et al, titled: "Topographic diversity of fungal and bacterial communities in human skin". The paper has been published in Nature.

The abstract reads:

"Traditional culture-based methods have incompletely defined the microbial landscape of common recalcitrant human fungal skin diseases, including athlete’s foot and toenail infections. Skin protects humans from invasion by pathogenic microorganisms and provides a home for diverse commensal microbiota1. Bacterial genomic sequence data have generated novel hypotheses about species and community structures underlying human disorders2, 3, 4. However, microbial diversity is not limited to bacteria; microorganisms such as fungi also have major roles in microbial community stability, human health and disease5. Genomic methodologies to identify fungal species and communities have been limited compared with those that are available for bacteria6. Fungal evolution can be reconstructed with phylogenetic markers, including ribosomal RNA gene regions and other highly conserved genes7. Here we sequenced and analysed fungal communities of 14 skin sites in 10 healthy adults. Eleven core-body and arm sites were dominated by fungi of the genus Malassezia, with only species-level classifications revealing fungal-community composition differences between sites. By contrast, three foot sites—plantar heel, toenail and toe web—showed high fungal diversity. Concurrent analysis of bacterial and fungal communities demonstrated that physiologic attributes and topography of skin differentially shape these two microbial communities. These results provide a framework for future investigation of the contribution of interactions between pathogenic and commensal fungal and bacterial communities to the maintenance of human health and to disease pathogenesis."

One interesting thing from the paper is in relation to fungi. The team found an average of 50 species of fungi living on the feet of 10 healthy adults. For the study, the scientists also swabbed other body part of the volunteers. Sites selected included behind the ear, between the eyebrows, and on the chest, back, nostril, scalp, and various parts of the arm.

However, fungal communities were most diverse on the foot. The diversity was not such in numbers and types for any one moment in time, for when the researchers re-sampled the study volunteers a couple of months later they found that the fungal communities had changed and different species were found. This is unlike other parts of the body, where the fungal types were relatively stable.

The parts of the foot showing the greatest diversity were the plantar heel, toenail and toe web.

For further details about this study, see Pharma Micro.

Posted by Tim Sandle

Automated Microbial Identifications: A comparison of USP and EP approaches

Microbial identification places an important role in pharmaceutical processing. Microbial identification can be defined as “microbial characterization by a limited spectrum of tests pre-chosen and appropriate to the problem being studied”.

Whilst the pharmaceutical microbiologist now faces a somewhat bewildering array of different test systems, once the selection has been made it is important, from a GMP perspective, that the system is validated. For this, both the United States Pharmacopeia and European Pharmacopeia offer some guidance. In general, the two approaches share more similarities than differences. There are, however, some aspects which are not in agreement. These are important to understand for those working for global pharmaceutical organizations, where inspections from different national regulators may occur.

To explore this further, Tim Sandle has written a paper for the AmericanPharmaceutical Review.

The reference is:

Sandle, T. (2013). Automated Microbial Identifications: A comparison of USP and EP approaches, American Pharmaceutical Review, 16 (4): 56-61

The paper can be viewed online here.

Posted by Tim Sandle

Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products

The FDA have issued a new guidance document entitled ‘Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products’.

The brief for the document reads: “This document provides guidance to industry and FDA staff on the applicability of current good manufacturing practice provisions to combination products as defined under 21 CFR 3.2(e). Such provisions apply to the manufacture of combination products to ensure that the product is not adulterated; the product possesses adequate strength, quality, identity, and purity; and the product complies with performance standards as appropriate for the marketed combination product.”

For further details, see A3P

Posted by Tim Sandle

Blue light for treating bacterial infections

Blue light can selectively eradicate Pseudomonas aeruginosa infections of the skin and soft tissues, while preserving the outermost layer of skin, according to a new study published in the journal Antimicrobial Agents and Chemotherapy.

For further details see:

T. Dai, A. Gupta, Y.-Y. Huang, R. Yin, C. K. Murray, M. S. Vrahas, M. Sherwood, G. P. Tegos, M. R. Hamblin. Blue light rescues mice from potentially fatal Pseudomonas aeruginosa burn infection: efficacy, safety, and mechanism of action. Antimicrobial Agents and Chemotherapy, 2012

Posted by Tim Sandle

Enterococcus faecalis

The bacterium, Enterococcus faecalis, is the second-leading cause of hospital-associated infections in the U.S. E. faecalis is naturally found in the gastrointestinal tract of humans and other mammals. But outside the intestinal walls, the bacteria can cause bacteremia, urinary tract infections and endocarditis. It has been suggested that the bacteria are 100 to 1,000 times more resistant to lysozyme than other bacteria (lysozyme is an infection-fighting substance that humans produce and is found in numerous body tissues, such as tear film, the urinary tract and saliva).

As part of the fight against this dangerous pathogen, researchers have discovered how a regulatory system helps this bacteria resist a host's innate immune defense -- a finding that may help develop novel drug compounds to fight the bacteria.

By understanding the bacteria's regulatory network, the researchers hope to develop novel drug compounds that can block the bacterium's ability to sense and respond to the presence of lysozyme and other stresses during infection.

To read about this important step, refer to the following paper:

S. Varahan, V. S. Iyer, W. T. Moore, L. E. Hancock. Eep Confers Lysozyme Resistance to Enterococcus faecalis via the Activation of the Extracytoplasmic Function Sigma Factor SigV. Journal of Bacteriology, 2013; 195 (14): 3125 DOI: 10.1128/JB.00291-13

Posted by Tim Sandle

New Device Traps Particulates, Kills Airborne Pathogens

A new device called a soft x-ray electrostatic precipitator protected immune-compromised mice from airborne pathogenic bacteria, viruses, ultrafine particles, and allergens, according to a paper published online ahead of print in the journal Applied and Environmental Microbiology. The SXC ESP device multiple potential uses, and Washington University is working on licensing the technology.

"Small particles are difficult to remove, and our device overcomes that barrier," says Pratim Biswas of Washington University, St. Louis. "The device not only captures particles with a high level of efficiency that has never before been achieved; it also inactivates them. Even bioterror agents are blocked and completely inactivated."

The range of potential uses includes indoor protection of susceptible populations, such as people with respiratory illness or inhalation-induced allergies, and young children; protection of buildings from bio-terror attack; protection of individuals in hospital surgical theaters (for example, during open organ surgery); protection in cleanrooms for semiconductor fabrication; removal of ultrafine particles in power plants; and capture of diesel exhaust particulates.

The device could be used in homes, with a cost similar to that of high efficiency air cleaners. It could also be added into stand-alone indoor air cleaners, or incorporated into HVAC systems in homes, offices, and aircraft cabins. In the study, the device exceeded standards for high efficiency articulate air filters, which must be capable of removing particles larger than 0.3 micrometers with 99.97 percent efficiency.

The SXC ESP works by placing a charge on the particles and then using an electrical field to trap the particles. The SXC unit then also completely inactivates biological particles by irradiating them and photoionizing them—as UV light does, only more energetically.

Source: American Society for Microbiology

Posted by Tim Sandle

Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements

This draft guidance describes FDA current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to CGMP. In particular, it describes how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. This guidance applies to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), finished drug products, combination products, and biological drug products.

For further details, see FDA

Posted by Tim Sandle

GMP Guide for Cosmetic Products (FDA)

The US FDA has published a Good Manufacturing Practice Guide for Cosmetic Products. This is a draft Guideline, and it includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, handling of complaints and reports of adverse events as well as on conducting recalls.

The new guidance can be viewed here: Cosmetics guidance for industry

Thanks to the ECA for the information.

Posted by Tim Sandle

Recommended Practices for Manual Aseptic Processes

The PDA have released a new technical report of interest: PDA Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes

The purpose of TR 62 is to outline methods and approaches for control and evaluation of aseptic processing operations for drug products/medicinal products which use all or partially manual procedures. TR 62 has value for hospital and formulation pharmacies where manual aseptic processing may occur. The guidance provided in this report may be applicable to operations including: vaccine preparation, cell culture, gene therapy, Investigational New Drug/IMP manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing.

For further details, see PDA

Posted by Tim Sandle

Pharmaceutical Regulatory Inspections - A Practical Guide

A new book of interest has been published. The book it titled 'Pharmaceutical Regulatory Inspections - A Practical Guide'.

The book provides a framework, coupled with in-depth analysis, of current issues pertaining to international pharmaceutical regulatory inspections. The book contains practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings.

The chapters are:

1. Basic Concepts of Global GMP Requirements by Tim Sandle & Madhu Raju Saghee
2. FDA Drug Regulation and Enforcement by Seth Mailhot
3. System Based Approach to Inspections by David Barr & Tim Sandle
4. Preparing for Preapproval Inspections by Ron Johnson
5. Effectively Managing and Surviving FDA Inspections by John Avellanet
6. Guide for Successful EU Inspection Management by Siegfried Schmitt & Nabila Nazir
7. Regulatory Requirements of Japanese GMP Inspections by Yoshikazu Hayashi
8. Preparing and Management of International Inspections by Andreas Brutsche & Tim Sandle
9. Handling and Responding to Post inspectional Observations by Tim Sandle, Madhu Raju Saghee & David Barr
10. Preparing for Regulatory Inspections of Sterile Facilities: The Focal Points by Tim Sandle
11. Preparing for Regulatory Inspections of API Facilities: The Focal Points by Siegfried Schmitt & Richard Einig
12. Optimizing your Regulatory Compliance by Mark Tucker

The book has been edited by Madhu Raju Saghee.

The book has been published by Euromed Communication, for details see: Pharma Book.

Posted by Tim Sandle

NHS QA Symposium for Technical Services (September 2013)

Details of an important course for those working in healthcare or quality assurance:

NHS Pharmaceutical Quality Assurance Committee

This annual event is aimed at pharmacy professionals, including technicians and pharmacists, working in pharmaceutical production and quality assurance environments. The symposium is aimed at both the NHS and commercial sectors.

The format encourages delegates to structure their own experience of the event around their individual needs and interests with a range of lead presentations, workshops and commercial presentations. The social aspect on the evening of day one allows opportunity for further discussion and networking. The exhibition provides a great opportunity to speak to pharmaceutical companies and equipment suppliers. All the companies you need to develop your service in one place.

Tuesday 24th – Wednesday 25th September 2013

The Crowne Plaza, Chester, UK.

For details, see the course brochure.

Posted by Tim Sandle

PDA 8th Annual Global Conference on Pharmaceutical Microbiology

PDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpuf

PDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpufPDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpuf

PDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpuf

PDA 8th Annual Global Conference on Pharmaceutical Microbiology

This annual conference is dedicated to advancing science and regulation for global pharmaceutical microbiology by introducing the best practices of today and innovations of tomorrow.

The PDA 8th Annual Global Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that our industry faces on a daily basis. The comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.

During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies.

For further details, see the refer to the course brochure. 

Posted by Tim Sandle

USP Seeks Submission of Proposals for Monograph Modernization

USP has embarked on a global initiative to modernize many of our existing monographs across all compendia. Having current monographs is tantamount to our mission of providing high-quality public standards. Towards that end, we are seeking industry collaborators to assist us in the development of these monographs. Please review the attached list. It contains the names of the top 428 high priority monographs requiring modernization.

USP intends to modernize these monographs as soon as possible utilizing one of two primary ways: traditional submission from a stakeholder (e.g. manufacturer of article) or USP’s internal laboratory efforts. Monographs for which USP fails to receive submissions by December 31, 2013 will be directed to our laboratory.

There are two ways in which you can help:

• Submit your current analytical methods
• Provide sample amounts of the article for USP’s internal lab development

For more information or to inform us of your participation, please contact the Standards Acquisition Department at stacq@usp.org

Posted by Tim Sandle