Pharmig Guide to Bacterial Identification

Pharmig’s latest publication is a guide to bacterial identification. The guide discusses why identification is important and what needs to be identified, answering the often-challenging questions of ‘what’, ‘when’ and ‘how often’?

There are several text books on identification. These, however, err towards the clinical. Texts on identification approaches for pharmaceutical microbiology are not common and guidance on understanding the appropriate level of identification is difficult to obtain.

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 probable point of origin. In deciding what and when (and subsequently to what level) to identify, and by the way of which methods, requires an identification strategy. This is a document each microbiology laboratory should develop.

Many parts of pharmaceutical microbiology are outlined in compendia or in guidance documents issued by regulators; included within these are the importance of bioburden assessments of intermediate and finished products, and the need to monitor the environment using standard environmental monitoring methods. What is less clear is expectation with regards to microbial identification. For identification, there are established and emerging methods, based around the microbial phenotype or genotype, yet the choice between systems is not straightforward and the selection depends, in part, on what needs to be identified. Deciding which types of samples to identify; what level of identification is appropriate (morphology, genus, or species); and what can be done with the collected information needs careful thought.

Written by Dr. Anna Lovatt (GSK) and Dr. Tim Sandle (BPL), the guide discusses different methods for phenotypic and genotypic identification, and the latest rapid methods. Troubleshooting sections and case notes are included with each section. The guide comes with a foreword from Andrew Hopkins of the MHRA.

The reference is:

Lovatt, A. and Sandle, T. (2018) Guide to Bacterial Identification, Pharmig, Stanstead Abbotts, UK

For details contact Pharmig

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration

FDA has issued new draft guidance: “Use of Liquids and/or Soft Foods as Vehicles for Drug

Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments Guidance for Industry.”

The introduction reads: “This guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids3 18 and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications. This guidance addresses the approaches recommended for suitability determination of vehicles intended for use with specific drug products by providing the following…Considerations for selection of liquids and/or soft foods as vehicles…Standardized in vitro methodology and data recommendations for drug product quality assessments to qualify vehicle(s) for drug product administration… Recommendations to communicate acceptable (qualified) vehicles in drug product labeling. If certain foods are found unacceptable, they should also be included in the labelling.

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM614401.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmig Annual Conference 2018

Pharmigs 26th Annual Conference Programme Interactive 2018 Final (1) by Tim Sandle on Scribd

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

James Vesper and Tim Sandle have a new book – ‘GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry’, Fifth Edition, Revised and Expanded.

The Long-Awaited Revision and Update of GMP in Practice is Here!

Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth edition, Revised and Expanded.

As companies strive to harmonize global requirements for quality systems, the 5th edition of this text provides an overview of the 34 essential global cGMP requirements that are typically included in a modern pharmaceutical quality system, including data integrity and how they have evolved. Explore risk-related questions, delve into several expectations for each quality system element encompasses, and review real-world examples from cGMP regulations from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH).

If you're looking for an enhanced understanding of GMP in practice, this text is a must-have for your reference collection.

See: https://store.pda.org/ProductCatalog/Product.aspx?ID=4511

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Avoiding environmental monitoring ‘false negatives’

In addition to selecting the right culture media, the use of an appropriate neutraliser is important in relation to surface, and some personnel, monitoring. Neutralisers are required to overcome any residues left by disinfectants, as can be found on cleanroom surfaces or on the gloved hands of personnel. The use of a neutraliser within the culture media formulation is also necessary to overcome residues from antimicrobial compounds so that a false negative is avoided.

The use of a neutraliser is recommended in the biocontamination control standard ISO 14698;3 and, outside of pharmaceuticals, the cosmetics microbiological test standard ISO 21149 contains some useful advice on neutraliser selection.

Tim Sandle has written a new paper on the topic of neutralisers for culture media. The introduction reads:

“The selection of an appropriate neutraliser is not straightforward. The neutraliser must be non-toxic to the microorganisms expected to be recovered; be able to stop residual disinfectant activity; and, in use. This latter requirement often proves the most challenging. This article examines the most common neutralisers used; some of the problems associated with their selection; and the complexities around using the most appropriate neutralisers in the culture media most commonly used in the environmental monitoring programme.”

The reference is:

Sandle, T. (2018) Avoiding environmental monitoring ‘false negatives’: overcoming disinfectant residues with culture media neutralisers, European Pharmaceutical Review, 23 (4): 18-21

The article can be accessed here: https://www.europeanpharmaceuticalreview.com/wp-content/uploads/epr418-EnvMonitoring-IDF.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Working with Biohazards

Working with human pathogens or biohazards poses serious risks, not only for employees, but for the public and communities as well. Infectious agents such as microorganisms, viruses, recombinant or synthetic nucleic acid molecules, and biological toxins present a potential for severe or lethal disease, adverse health effects, or contamination. Any unplanned exposure or release has the potential to cause extensive harm or damage to people, the environment, and society.

Vince McLeod has written an interesting article for Laboratory Manager. Here is an extract:

“The foundation for safe handling and research with infectious/biohazardous agents is an effective exposure control plan (ECP). This article discusses the basic elements of a comprehensive exposure control plan, what each element should address, and advice for successful implementation.

The ECP is essentially a biohazard safety manual developed to address the unique conditions of the current research, facility design, and personnel operations necessary to carry out the laboratory’s mission. One excellent free reference is the CDC’s Biosafety in Microbiological and Biomedical Laboratories1 (BMBL), which contains comprehensive information on biological risk assessment and summary statements on many common infectious agents.”

To access the article, see: https://www.labmanager.com/lab-health-and-safety/2018/05/working-with-biohazards

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology