Friday, 5 February 2016

Reducing the Risk of Human Immunodefciency Virus Transmission by Blood and Blood Products

The U.S. FDA’s Center for Biologics Evaluation and Research released a Guidance for Industry this month titled “Revised Recommendations for Reducing the Risk of Human ImmunodefciencyVirus Transmission by Blood and Blood Products.” Recommendations address various considerations relating to the minimization of HIV transmission risk, including:

• Donor deferral
• Donor requalifi cation
• Product retrieval and quarantine
• Product disposition and labeling
• Testing requirements

This guidance finalizes a draft guidance of the same title dated May 2015, and supersedes a 1992 memorandum. Like other FDA guidance, this document describes the FDA’s current thinking on this topic, and does not establish legally enforceable responsibilities on the part of industry.

Posted by Dr. Tim Sandle

Thursday, 4 February 2016

Testing for High Containment Gloveboxes

High containment gloveboxes (HCG) have been used in the pharmaceutical industry for containment of potent compounds, along with providing specific environmental conditions, for years. These types of glovebox design fit well into the Class III Bio Safety Cabinet classifications but provide even better environmental attributes than the standard BSC designs.

Once you have decided on the best system and design, testing needs to completed. Testing methods are standard and can be applied to the HCGs. Testing of the HCGs would conform to the industry standard.

In relation to this, Controlled Environments has an article on this subject by Michelle Frisch. The article can be accessed here.

 Posted by Dr. Tim Sandle

Antimicrobial resistance (AMR): improving prescribing practice

The latest edition of Public Health England’s Health Matters says reducing unnecessary prescribing of antibiotics can play an important role in tackling antimicrobial resistance.

Antimicrobial resistance is a growing problem and represents a major threat to public health. We rely heavily on antibiotics and the pressure on healthcare professionals to prescribe is great, even when they are not needed. We need to conserve antibiotics and use them appropriately or we risk losing the power of these medicines.

This second edition of Health matters focuses on inappropriate use and overuse of antibiotics and sets out how local authorities and the NHS can work together to tackle one of the most significant threats to public health

For further details, see Public Health England

 Posted by Dr. Tim Sandle

Wednesday, 3 February 2016

Advancement of Emerging Technology Applications

U.S. FDA has published new guidance of interest. The guidance is titled “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry.”

The guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology to FDA.

The program is open to companies that intend the technology to be included as part of an investigational new drug application (IND) or original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance.

According to FDA:

“Issues in pharmaceutical manufacturing have the potential to significantly impact patient care in that failures in quality may result in product recalls and harm to patients. Additionally, failures in product or facility quality are a major factor leading to disruptions in manufacturing.

Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance. For example, contemporary aseptic manufacturing facilities that are highly automated and use isolators and other modern separation technologies have the potential to decrease the risk of contamination from the processing line. Encouraging the development of emerging manufacturing technology may lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle”

For details, see FDA


Posted by Dr. Tim Sandle

Tuesday, 2 February 2016

Raw materials of biological origin for the production of cell-based and gene therapy medicinal products

A new chapter has been added to the European Pharmacopeia (5.1.2) on raw materials of biological origin for the production of cell-based and gene therapy medicinal products. The chapter is for information only and not legally binding.

The chapter includes sections on the risk, origin, production of and quality requirements for raw materials of biological origin used for the production of cell-based and gene therapy medicinal products for human use.

The chapter aims to assist stakeholders in ensuring raw materials are of suitable quality and to foster harmonisation in the qualification practices and standards to be applied.

This chapter was published in the 9th Edition of the European Pharmacopoeia and became effective on 1 January 2017.

 Posted by Dr. Tim Sandle

Monday, 1 February 2016

Webinar - ISO 14644 Updates

This is FREE for 2016 Pharmig Members (membership needs to be confirmed on booking the free webinar)

Details for booking into the webinar are outlined below – please follow the links or copy and paste into your browser
Join us for a webinar on Feb 04, 2016 at 2:00 PM GMT.
Register now!
Led by Tim Sandle this session will cover:
  • Key points from the ISO 14644 Parts 1 and 2 update
  • What this means for cleanroom classification
  • Implications for routine monitoring of cleanrooms
  • Connection between ISO 14644 and EU GMP Annex 1
  • ISO 14644 and risk assessment
The presentation will run for 30mins with 15mins available for Q&A
£100 Non Member Rate
Credit card payments can be made via this website
Or Pharmig can send you an invoice
After registering, you will receive a confirmation email containing information about joining the webinar.

For more details see: Pharmig

Posted by Dr. Tim Sandle

Current Developments with Disposable Technology and Single-Use Systems for Aseptic Processing

Pharmaceutical drug products are produced to be efficacious; however the presence of microorganisms or microbial by-products in these products may have adverse effects on their efficacy. Contamination of aseptically filled biotechnological products is costly and it can pose serious harm...

In relation to this technology, Tim Sandle has written an article for BioPharma Asia magazine. The reference is:

Sandle, T. (2015) Current Developments with Disposable Technology and Single-Use Systems for Aseptic Processing, BioPharma Asia, 4 (6): 5-11

See: BioPharma Asia

 Posted by Dr. Tim Sandle

Sunday, 31 January 2016

World Leprosy Day

Many of us might have lost the thought of the word ‘Leprosy’, thinking the disease eradicated long back. Unfortunately, suffering still remains. For over more than 60 years, last Sunday of January is observed as World Leprosy day across the world to increase public awareness of the disease.

French writer & humanitarian, Raoul Follereau, initiated this great thought with a vision to spread global awareness about the disease & ways to prevent & cure it.

It may also interest you to know that this day coincides with the assassination day of Indian freedom fighter, Mahatma Gandhi. He once said, “Eliminating leprosy is the only work I have not been able to complete in my lifetime.”

Leprosy is a disease caused by a bacillus, M. Leprae (Mycobacterium leprae, a relative of tuberculosis germ). It is chronic, affecting the skin & nerves – especially those going to the legs, arms & face.
Health Records
Leprosy is curable still we have millions suffering from this diseases. If detected early, disabilities can be prevented. It is curable with multi-drug therapy (MDT) which was developed in the early 1980s. MDT consists of 3 drugs: rifampicin, clofazimine & dapsone. Treatment takes from 6 months to 2 years depending on the severity of the case.

Posted by Dr. Tim Sandle

Pharmeuropa - Useful information

EDQM has published a document outlining useful updates edition 8.8 of the European Pharmacopeia.

Areas of change include:

2.2.3. Potentiometric determination of pH
2.2.46. Chromatographic separation techniques
2.4.22. Composition of fatty acids by gas chromatography
2.4.32. Total cholesterol in oils rich in omega-3 acids
2.6.8. Pyrogens

·         The text has been revised to include a reference to general chapter 2.6.30. Monocyte activation test as a potential replacement of the test for pyrogens, therefore avoiding the use of live animals.

5.1.10. Guidelines for using the test for bacterial endotoxins

·         A section has been added (section 2-4) to include aspects to be considered when establishing an endotoxin limit for a specific substance or product; also, the text has been revised to reflect the fact that an endotoxin limit is not always provided in a specific monograph.
·         Reference is made to general chapter 2.6.30. Monocyte-activation test as an alternative to the rabbit pyrogen test.
·         Reference is made to the use of alternative reagents to the Limulus amoebocyte lysate, such as recombinant factor C.
·         Method A is no longer declared as the reference method, and all methods A to F of general chapter 2.6.14. Bacterial endotoxins can be used.
·         The expression ‘threshold endotoxin concentration’ has been replaced by the more appropriate expression ‘endotoxin limit concentration’ to harmonise with general chapter 2.6.30. Monocyte-activation test.
·         A new entry has been included in Table 5.1.10.-1 for formulations administered per square metre of body surface.

5.3. Statistical analysis of results of biological assays and tests

5.4. Residual solvents

Radiopharmaceutical preparations (0125)

Substances for pharmaceutical use (2034)

Posted by Dr. Tim Sandle

Saturday, 30 January 2016

Software Identifies Drug Resistance from Bacterial Genomes

Scientists have developed an easy-to-use computer program that can quickly analyze bacterial DNA from a patient's infection and predict which antibiotics will work, and which will fail due to drug resistance. The software is currently being trialed in three UK hospitals to see whether it could help speed up diagnosis of drug-resistant infections and enable doctors to better target the prescription of antibiotics.

The Mykrobe Predictor software, developed by Dr. Zamin Iqbal and colleagues at the Wellcome Trust Centre for Human Genetics, University of Oxford, runs on a standard laptop or tablet without the need for any specialist expertise. The program can analyze the entire genetic code of a bacterium in under 3 minutes, once a bacterial sample has been cultured and its DNA sequenced.

A study on more than 4,500 retrospective patient samples, published in Nature Communications, shows that Mykrobe Predictor accurately detects antibiotic resistance in two life-threatening bacterial infections: Staphylococcus aureus (one form of which causes MRSA) and tuberculosis (TB).

The paper is titled “Rapid antibiotic resistance predictions from genome sequence data for S. aureus and M Tuberculosis.”

Posted by Dr. Tim Sandle

Friday, 29 January 2016

EN 14885:2015

A European Standard, providing an overview of disinfectant testing, has been updated and published. It is EN 14885 and it is titled “Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics.”

Key words are: Disinfectants, Antiseptics, Cleaning materials, Disinfectant tests, Microorganisms, Bacteriocide-activity determination, Bacteriocides, Viruses, Fungicides, Eumycophyta, Testing conditions, Medical equipment, Veterinary science, Food industry, Industrial, Domestic, Marking, Terminology.

The standard was last revised in 2006.

See: EN 14855

Posted by Dr. Tim Sandle

Thursday, 28 January 2016

A Practical Approach to the Selection of Cleanroom Disinfectants

Cleanrooms play an important role in hospitals, from special environments for the preparation of medicines in pharmacies to providing clean air zones for operations. Cleanrooms are designed with special air filters (high efficiency particulate air) to provide ‘clean air’, have positive pressure differentials to prevent the ingress of less clean air, and have strict entry and clothing requirements for personnel. Nevertheless cleanroom surfaces can become contaminated with microorganisms, transported in from consumables and equipment or shed from personnel. Surfaces pose a risk if they harbour high numbers of bacteria and fungi as such microorganisms can be readily transferred. Thus, an important part of contamination control within a cleanroom requires the use of cleaning and disinfection agents. A second risk arises within hands. Hands, whether gloved or ungloved, are one of the main ways of spreading infection or for transferring microbial contamination and the use of hand disinfectants is also part of the process of good contamination control.

In relation to this, Tim Sandle has written an article for Pharma Focus Asia.

The reference is:

Sandle, T. (2014) A Practical Approach to the Selection of Cleanroom Disinfectants, Pharma Asia Online.

The article can be accessed for free here

Posted by Dr. Tim Sandle

Wednesday, 27 January 2016

Antibiotic Resistance and You

Public Health England wants to hear from members of the public about their views on antibiotic resistance. This public event is taking place in London on 24th February at the UCL John Hunbury Theatre, Russel Square, London.
  • This free to attend event will cover:
  • antibiotics and why they are so valuable
  • what is antibiotic resistance and how it affects you and your family
  • what we can all do to help solve the crisis of antibiotic resistance
You, your friends and family are invited to book your free spot today.

Posted by Dr. Tim Sandle

Bromate Determination in Water

The determination of the bromate content of water is a challenge that can be met either by using an elaborate ion chromatography system or a photometric method. Both approaches demand careful handling and a critical appraisal of the result that is yielded. If the necessary working steps are carefully followed, photometry constitutes a true alternative to chromatography for those laboratories that do not possess ion chromatography systems.

Laboratory Manager is offering a free white paper on this subject, which can be requested here.

Posted by Dr. Tim Sandle

Biocidal Products Regulation

The European Chemical Agency has issued “Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants”. This legislation will affect the number and types of disinfectants registered in the European Union.

The document states: “This Transitional Guidance deals with the evaluation methodology of efficacy tests for disinfectants for the national and Union authorisations of products under the EU Biocidal Products Regulation 528/2012 (BPR).”

The types of efficacy claims made for a disinfectant/ biocidal product depend upon, among other things, the types of micro-organisms the disinfectant targets (e.g. fungal spores, yeasts, mycobacteria, bacteria or bacterial spores) and the disinfectant’s intended use (e.g. in hospitals, in contact with food, in animal houses, in homes). Label claims and recommendations for use, including concentration and contact time, must be supported by the results of bactericidal, fungicidal, etc. tests appropriate to the area of application, which are normally performed on the basis of the specific standards. Complete instructions for use are an integral part of the label.

The document can be accessed via the ECA.

Posted by Dr. Tim Sandle