Tuesday, 30 June 2015

Bioprocessing and Sterile Manufacturing


Pharmaceutical Technology has issued a new e-book called “Bioprocessing and Sterile Manufacturing.”

According to the blurb: “The editors examine novel technologies for the development, manufacture, purification, and delivery of small- and large-molecule drugs, including single-use systems, lyophilization, andmicrobial monitoring. Aging facilities and the future of aseptic processing are featured topics.”

Topics covered include: The Future of Aseptic Processing; Disposable Technology versus Traditional Stainless Steel; Controlled Nucleation for a mAb Formulation; Evaluating and Validating a Rapid Microbial Monitoring System; Sterilization and Its Impact on Elastomers in Self-Injectable Syringes; Bioburden: Testing, Monitoring, and Prevention; Issues with Aging Facilities.

To access a copy, go to PT.

Posted by Tim Sandle

Monday, 29 June 2015

Real time biological particle counting


Spectrophotometric particle counters measure the number and size of inert and biologic particles from a volume of air (and thus enable ‘real-time’ microbiological assessment.) Such systems operate in a similar way to conventional particle counters, which measure inert particles as part of the GMP assessment of cleanrooms (and comply with such cleanroom standards as ISO 14644). Here the instruments count airborne particles by measuring light scattering. The difference with the spectrophotometric counters over traditional counters is that the instruments are capable of determining if the detected particles are biological or inert. Thus the key innovation is that such devices can differentiate between non-viable particles and biological material, which may indicate if microorganisms are present in the sample of air.

The implementation of such technologies is in keeping with the industry and regulatory drive, particularly from the US Food and Drug Administration, for rapid methods and for pharmaceutical manufacturers to utilise the concept of process analytical technology (PAT).

In relation to this cutting edge rapid microbiological method technology, Tim Sandle has written an article for European Pharmaceutical Review.

The reference is:

Sandle, T. (2015) Real-time biological particle counting in environmental monitoring, European Pharmaceutical Review, Vol. 20, Issue 2, pp39-42

For details see European Pharmaceutical Review or contact Tim Sandle.

Posted by Tim Sandle

Sunday, 28 June 2015

ISO 9001 in revision


ISO 9001, the world's leading quality management standard, is under revision, with an updated version due by the end of 2015.

The new version will follow a new, higher level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk.

ISO 9001 is about to reach the Final Draft International Stage (FDIS ballot expected by July), the fifth stage of a six stage process, whereby the ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward to all ISO members for voting.

For more details, see the video below:



Posted by Tim Sandle

Saturday, 27 June 2015

Risk of toothbrushes in communal bathrooms

Data confirms that there is transmission of fecal coliforms in communal bathrooms at Quinnipiac University and that toothbrushes can serve as a vector for transmission of potentially pathogenic organisms. This research is presented at the annual meeting of the American Society for Microbiology.

"The main concern is not with the presence of your own fecal matter on your toothbrush, but rather when a toothbrush is contaminated with fecal matter from someone else, which contains bacteria, viruses or parasites that are not part of your normal flora," said Lauren Aber, MHS (Graduate Student, Quinnipiac University). Potential microorganisms that can be introduced are enteric bacteria and pseudomonads. Enteric bacteria are a family of bacteria, Enterobacteriaceae, they are known to be normal flora found in the gut. They are also known to ferment glucose, fail to contain cytochrome in an oxidase test and many can reduce nitrates to nitrites. Pseudomonas group of bacteria are gram-negative aerobic rods commonly found in soil, water, plants and animals. They are part of the normal flora of the gut and also on the skin of humans.

For further details, see Medical Net

Posted by Tim Sandle

Friday, 26 June 2015

ASM working on open access microbiology book

Rice University-based publisher OpenStax College and the American Society for Microbiology Press have announced they are teaming up to produce Microbiology, a new introductory-level textbook due for release in spring 2016 that will be free online and low-cost in print.

The collaborative publishing agreement -- the first for each partner -- will produce a peer-reviewed, open-copyright textbook. More than 300,000 U.S. college students take an introductory microbiology course for allied health majors each year, and the new book could save them an estimated $30 million over the next four years, according to Richard Baraniuk, the founder and director of OpenStax College and Rice's Victor E. Cameron Professor of Electrical and Computer Engineering.

For further details see: Houston News

Posted by Tim Sandle

Thursday, 25 June 2015

Infection Control Tomorrow Digital Summit


Infection Control has issued a special edition of its magazine, in electronic format. The issue celebrates the infection prevention profession that began with the Infection Control Tomorrow Digital Summit, held April 29-30, 2015. The issue provides infection prevention experts' perspectives on key issues facing the field, and explores the past, present and future of infection prevention and control.

Content includes: 
  • Editor's Letter: Celebrating the Infection Prevention Profession
  • Professional Survival: Let Yourself Laugh
  • Exploring Infection Prevention's Biggest Challenges and Opportunities
  • The Evolution of Infection Prevention: Past, Present and Future

To download a copy, see Infection Control.

Posted by Tim Sandle

Wednesday, 24 June 2015

Safe use of disinfectants and detergents in cleanrooms

Disinfectants and detergents form part of the contamination control strategy in cleanrooms and controlled environments. While it is important that these chemicals are effective, it is also important that they are safe to use.

Recently a raft of new safety legislation has emerged about handling of chemicals, personnel protective measures, and environmental controls (in terms of occupational exposure and waste disposal).

Tim Sandle assesses the key points and unravels the consequences for cleanroom users in a new article for the UK Science Parks Association.

The article can be viewed on-line here, from page 81. The reference is:

Sandle, T. (2015) Safe use of disinfectants and detergents in cleanrooms, Innovation to Success (quarterly journal of UKSPA), Issue 38, pp81-84

Posted by Tim Sandle

Tuesday, 23 June 2015

Standards for Microbiology Investigations (SMI)


SMIs are a collection of recommended algorithms and procedures for clinical microbiology.

The new standards are developed and reviewed by the SMI Steering Committee, which includes Society for General Microbiology representative Professor Jodi Lindsay (St George’s University of London).

Details about recent reissued and withdrawn SMI documents can be found on this website and people can contribute to public consultations that are run to inform the development of SMIs.





Posted by Tim Sandle

Monday, 22 June 2015

Non-endotoxin Microbial Pyrogens


Pyrogens of microbial origin need to be considered in relation to the risks they pose to pharmaceutical products. Despite the low theoretical risk posed by non-endotoxin pyrogens, questions of their occurrence and risks are sometimes raised by regulators through inspections and by assessors during license changes and submissions. When such questions arise the pharmaceutical manufacturer is often called upon to undertake a risk assessment. Some of the information outlined within this article could be helpful in developing such an assessment.

With this regard, Tim Sandle has written an article for the Journal of GXP Compliance.

The reference is:

Sandle, T. (2015) Assessing Non-endotoxin Microbial Pyrogens in Relation in Pharmaceutical Processing, Journal of GXP Compliance, Vol. 19, Issue 1, 1-10

For details see: IVT.

If you are interested in reviewing this, please contact Tim Sandle.

Posted by Tim Sandle

Sunday, 21 June 2015

Clinical Trials Project Management

Applied Clinical Trials has issued a new free e-book titled “Clinical Trials Project Management”.

According to the website: “Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this e-Book seeks to instruct others on best practices.”

The book addresses: Project managers view of functional outsourcing; What to expect in budget variances; Negotiating positively with sites; and Fair Market Value pricing for contracts.

For further details, see ACT.

Posted by Tim Sandle

Friday, 19 June 2015

Titanium sterile sporicidal disinfectant


Titanium is ideal for surface disinfection within controlled environments. It can be used on workbenches, shelves,equipment, printers, heat sealers and surfaces outside of the LAF cabinet for a daily deep clean and as part of a rotational regime.

For further details, see below.




Elderly - Growing Contributor to Tuberculosis in China


"A major contributor to the number of tuberculosis infections and cases in China will likely be the elderly over the next few decades, requiring a refocus in efforts to control a disease affecting millions of people in the country, according to preliminary new research presented today at the Fourth Global Forum on TB Vaccines in Shanghai."

This is a Eureka Science alert:

"The researchers from the London School of Hygiene & Tropical Medicine found that developing a “post-infection” vaccine could reduce overall TB rates in China by almost a third by 2050.

Globally, 2050 is the target year for eliminating TB as a public health problem. China is acknowledged to have made a great deal of progress in controlling the disease over the last 20 years, but it is still hard hit by the TB epidemic. According to the World Health Organization, China has an estimated 980,000 new cases of TB every year, second only to India, and 41,000 deaths each year result from the infectious, airborne disease. More troublingly, a third of the world’s drug-resistant TB cases are found in China.

“We chose to study TB trends in China given the magnitude of the disease burden present and the anticipated increase in the number and proportion of elderly people within the population. We wanted to understand how these factors would affect the attempt to eliminate TB in the country,” said Rebecca Claire Harris, an epidemiologist with the London School of Hygiene & Tropical Medicine in the UK, who presented the results.

“This is the first time the possible impact of giving new TB vaccines to older adults has been considered in any setting, and could inform how future clinical trials and vaccine deployment plans are developed,” said Harris.

Preliminary study results predict that the elderly (those aged 65 years and above) contribution to TB infection transmission in China may increase from 18 percent to 53 percent, and their burden of TB disease may increase from 13 percent to 71 percent of all new TB cases.

“Our preliminary findings suggest that in China it may be useful to increase TB control efforts for preventing disease in older adults and the elderly, and that development of new TB vaccines aiming to protect this population could have substantial impact,” Harris said. “Targeting older adults is a departure from the current thinking in the field, which mostly focuses on developing vaccines for children and adolescents. This also may be different from other parts of the world, such as sub-Saharan Africa, where there is much more disease in young adults.”

According to the researchers, a combination of the success in China in bringing down TB transmission and the increasing size of the elderly population are contributors to this expected trend. The population that will be elderly during 2025 to 2050 may have been infected back in the pre-1990 era when transmission was still very high. As they get older, their risk of reactivation of infection increases, so they are more likely to develop disease and contribute to disease figures. Whereas because disease transmission has declined so much in recent years, younger people are now infected in relatively lower numbers, so the number of younger people developing disease will also become lower since most disease in this group is due to recent infection.

The researchers used mathematical models to explore the potential impact of new TB vaccines and found that some types could reduce the rate of TB in China by up to nearly a third by 2050. An effective vaccine option of those explored for China was found to be one that could be given to older adults, including those who have already been infected by the bacteria that cause TB but who haven’t yet developed TB disease. Such a vaccine, if it had 80 percent efficacy, 20 years duration of protection, and covered 70 percent of people aged 55-64 in 2025-27 and then 55 year olds as part of a routine program, could reduce the rate of new TB cases in China by 31 percent by 2050, avoiding up to 3.7 million cases between 2025-50, the results suggest. Even at lower efficacy and coverage, such a vaccine given to older adults could prevent hundreds of thousands of TB cases.

“If our research continues to validate results to date, it would highlight the importance of ensuring TB vaccine trials include these older age groups and that China begins to plan how a vaccine or other interventions to prevent infected people developing TB could be delivered to people of this age group,” said Harris. “However, these early results suggest that even the most effective older adult vaccine will need to be part of a wider control package to reach the WHO 2050 TB elimination goal in China.”

The global quest for new vaccines

BCG, the nearly 100-year-old existing TB vaccine, works most consistently in infants and is largely ineffective against the most common and contagious form of the disease, that is, TB in the lungs. Decades of widespread use of this vaccine has failed to control the global TB epidemic, leading researchers globally to work on development of new, more effective TB vaccines.

The two nonprofit organizations at the forefront of this vaccine development work, the U.S.-based Aeras and the Netherlands-based TuBerculosis Vaccine Initiative (TBVI), helped organize the international gathering of TB and TB vaccine experts in Shanghai this week.

“Tuberculosis is a major public health threat, tied with HIV as the leading cause of death globally among infectious diseases, with antibiotic resistance a major treatment challenge, yet we are years behind where we should be in vaccine development due to lack of acknowledgement of the TB health threat and the resultant lack of investment in new tools,” said Tom Evans, CEO of Aeras. “One of the reasons the global TB vaccine community is excited to meet in China is the level of commitment we’ve seen from the authorities here to innovative research, including developing the world’s only TB vaccine candidate currently in a Phase 3 trial.”

The Phase 3 trial of the Chinese vaccine, called VaccaeTM, is sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. Scientists running the trial of this vaccine, are providing an update on progress at the TB vaccine Forum. According to Aeras, aside from VaccaeTM, there currently are 14 vaccine candidates in various stages of clinical testing, including GSK’s M72+AS01E candidate, which is currently in Phase 2b testing at sites in Africa.

“The global clinical trial pipeline for TB vaccines is more robust than ever before, yet at the same time there is still much we need to learn about how TB exactly attacks the body and manages to evade the natural immune response,” said Tom Ottenhoff, member of the scientific team of TBVI. “Fortunately, the TB vaccine community has managed to come together at these forums in order to coordinate joint research efforts so that the relatively little funding available for our efforts is used in the most effective manner possible.”


 
TB can affect anyone but often strikes those who live in poverty, have poor nutrition, limited access to healthcare, and live in overcrowded conditions. In China, out-of-pocket TB treatment costs account for more than half of the average annual household income for the rural poor, according to Aeras. And because each individual with active TB typically infects between 10 and 15 others, entire families and communities are at risk."

Posted by Victor Grayson

Thursday, 18 June 2015

Human Microbiome Project and Pharmaceutical Quality Control Microbiology


James Agalloco has written a go0d article for Pharmaceutical Technology, looking into the implications of the Human Microbiome Project findings for pharmaceutical quality control microbiology.

Here is an extract:

"Some readers will be familiar with the staggering bacterial numbers reported by the various HMP studies that have appeared. With the identification of more than 10,000 bacterial species in the human microbiome so far, it is unsurprising that most of the known bacterial genera have been observed in association with healthy humans. The sheer number of total bacteria found in or on humans is an amazing ~1014, which is approximately 10-fold more than the number of human cells each of us contain. Obviously, the 1–2 kg of bacteria that constitute our normal flora are responsible for neither harm nor undue health risk within their particular niches or none of us would make it to adulthood. This should inform the reader that the sheer number of microorganisms in a product is unlikely to meaningfully change the population of bacteria present at the site of administration."

The article can be accessed here.

Posted by Tim Sandle

Wednesday, 17 June 2015

New mandatory logo for selling medicines online



From 1 July anybody in the UK selling medicines online to the general public needs to be registered with the MHRA and to be on the MHRA’s list of UK registered online retail sellers.

The MHRA states:

"They also need to display on every page of their website offering medicines for sale, the new European common logo which is registered to the seller.

The registered EU common logo will contain a hyperlink to their entry in the MHRA’s list of registered online sellers.

Anybody buying medicines online can check if the website is legitimately registered and will be able to click on the logo which will take them through to a list of approved sellers.

If the registered person retails a medicine through a third-party market place website, then the third-party market place service provider must display that registered person’s EU Common Logo on every page of their website that offers the registered person’s medicine for sale to the public from that service provider’s site.

This is a different scheme to the voluntary logo run by the General Pharmaceutical Council (GPhC). The EU common logo is a legal requirement across Europe whilst the GPhC run a voluntary logo scheme which is applicable only to registered pharmacies.

Under the rules of the new scheme the medicine being offered online must be licensed in the member state where the member of public who buys the medicine is based.

The person selling the medicine must be legally entitled to sell medicine to the public in accordance with UK medicines legislation.

Registered pharmacies can sell general sales list medicine, pharmacy medicine or supply prescription-only medicine that they have dispensed against a prescription. All other general retailers can only sell general sales list products.

The penalty for selling medicines online without being registered and not displaying the logo is up to 2 years in prison or a fine or both."

For further details, see UK Government.

Posted by Tim Sandle

Tuesday, 16 June 2015

Study provides new insights into Clostridium spores


Microbiologists from the Institute of Food Research have demonstrated how clostridia emerge from spores. This finding could help researchers understand how these bacteria germinate and go on to produce the toxin responsible for botulism (which triggers food poisoning), or cause food spoilage.

According to the Norwich BioScience Institutes:

"Dr Jason Brunt worked with microscopist Kathryn Cross to produce images of the stages spores go through during germination. Their images showed that the spores have an outer covering, called an exosporium, with an aperture at one end. Closer examination showed that this aperture aligned with a spot on the spore where it ruptures during germination, and that the newly formed cell emerges through these holes. This suggests that the spores have polarity that aligns the structures correctly."

For further details see:

Jason Brunt, Kathryn L. Cross, Michael W. Peck. Apertures in the Clostridium sporogenes spore coat and exosporium align to facilitate emergence of the vegetative cell. Food Microbiology, 2015; DOI: 10.1016/j.fm.2015.04.013

Posted by Victor Grayson

Monday, 15 June 2015

EU GMP updates 2015


Changes to EU GMP this year include:

Chapter 3: 'Equipment and Facilities' - updated guidance on preventing contamination including using Quality Risk Management principles to assess and control the risks. Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.

Chapter 5: 'Production' - improved guidance on prevention of cross-contamination (cross referencing with Chapter 3). Changes also introduced a new section on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP and supply chain traceability. Sections were inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials.

Chapter 7: 'Complaints, Quality Defects and Product Recalls' - extensive changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. It emphasises the need for the cause(s) of quality defects or complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue and clarifies expectations and responsibilities in relation to the reporting of quality defects to the authorities.

In addition to the main chapters:

Annexe 15: Qualification and Validation' - new version to be implemented in October 2015.

Annexe 16: 'Certification by a Qualified Person and Batch Release' - new version in preparation.

Posted by Tim Sandle

Sunday, 14 June 2015

Poster to pH Perfection


Correct and accurate pH measurements depend upon reliable instruments and electrodes. Selecting the right equipment and procedures for handling and maintenance are crucial for obtaining optimum results and prolonging instrument lifetime.

Why does your pH meter show results that are different than expected? What can you do to stop contamination? Does temperature influence your pH measurement?
A new poster from Anachem, on tips and tricks for pH measurements provides many practical ways to improve your results.

For details see: Anacehm

Posted by Tim Sandle

Industrial Pharmaceutical Microbiology: Standards and Controls

A new edition of the essential microbiology book “Industrial Pharmaceutical Microbiology: Standards & Controls” has been published by Euromed.

This publication covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare and it has been edited by Professor Geoff Hanlon and Dr. Tim Sandle.

The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes and cleanrooms, and how to effectively evaluate microbial risks to products from personnel and processes.

To meet the latest regulatory expectations, the role of the microbiologist is essential. In addition there is important input requirement from quality assurance personnel, engineers, and process specialists. Whilst there is a continuing need for monitoring of the environment and conducting standardised laboratory tests, industrial pharmaceutical microbiology has moved on a great deal in the past decade. It now has to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimising contamination, and reactive in terms of addressing microbial data deviations; and also ensuring that processes meet ‘quality by design’ principles. In this new 600 page book a team of 24 international authorities will assist you in all your questions.

Industrial Pharmaceutical Microbiology: Standards and Controls covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing; environmental monitoring to hazard analysis; and from pharmaceutical processes to biological indicators. All of this is developed from an international perspective, where different regulations are compared and contrasted together with insightful commentary as to best practices.

Industrial Pharmaceutical Microbiology: Standards and Controls provides clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharmaceutical microbiology.

The chapter list is:

Part A: The Role of the Microbiologist and the Microbiology Laboratory

1. Safety in Microbiology by Nigel Silman and John V Daniels

2. Best Practices in Microbiology Laboratory Training by Tim Sandle

3. The Use of Culture Media in Pharmaceutical Microbiology by Tim Sandle

4. Rapid Microbiological Methods and Process Analytical Technology (PAT) by Jeanne Moldenhauer

5. Microbial Risk Assessments for Operational Cleanrooms by Tim Eaton

6. The Role of the Qualified Person in Microbiological Quality Assurance by John Dolman

7. Auditing the Pharmaceutical Microbiology Department by Andy Martin

Part B: Microbiological Control and Industrial Processes
8. Microbiological Environmental Monitoring by Rosamund M Baird

9. Selection and Use of Cleaning and Disinfection Agents in Pharmaceutical Manufacturing by Tim Sandle

10 Microbiology of Pharmaceutical Grade Water by Tim Sandle

11. Biofilm Contamination in Pharmaceutical Facilities by Alex P Blanchard

12. Cleanrooms, Isolators and RABS: Basic Principles, Design, Testing, Operation and Regulatory Aspects by John Neiger

13. Aseptic Process Simulations/Media Fills by Marco Budini and Francesco Boschi

14. Filtration by Claire Jarmey-Swan

15. Sterilisation Technologies by Eric Dewhurst and Eamonn Hoxey

16. Biological Indicators by Tim Sandle

17. Endotoxins and Depyrogenation by Karen Zinc McCullough

18. Containment System Integrity: Microbial Challenges for Sterile Products by Tim Sandle

19. Challenges of Bacteriophage Therapy by Alexander Sulakvelidze

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

20. Microbiological Quality and Regulatory Requirements for Biotherapeutics by Daniel Galbraith

21. The Microbiological Quality and Regulatory Requirements for Natural and Nutraceutical Products by Martin Dennison

22. The Regulatory Control and Quality Assurance of Immunological products by Tim Sandle

23. Regulatory Guidelines (Microbiology) for Veterinary Medicinal Antimicrobial Products by Klaus Hellmann and Peter Silley

24. Regulatory Expectations for Non-Sterile Manufacture of Pharmaceutical Dose Forms by Edel Fitzmaurice

25. The Pharmacopoeias and Microbiology by V Fenton-May

For details and to order a copy, see: Euromed Communications: Industrial Pharmaceutical Microbiology: Standards & Controls - 2015 Edition
Posted by Tim Sandle

Saturday, 13 June 2015

Replacing the rabbit pyrogen test with a test for endotoxin

Some readers have asked about the replacement of the rabbit pyrogen test with a test for bacterial endotoxin (such as LAL). Within Europe, this is outlined in the European Pharmacopeia. In chapter “Substances for pharmaceutical use (2034)”, it reads:

“Pyrogens (2.6.8). If the test for pyrogens is justified rather than the test for bacterial endotoxins and if a pyrogen-free grade is offered, the substance for pharmaceutical use complies with the test for pyrogens. The limit and test method are stated in the individual monograph or approved by the competent authority. Based on appropriate test validation for bacterial endotoxins and pyrogens, the test for bacterial endotoxins may replace the test for pyrogens.”

Evidently a case must be made and discussion held with the appropriate regulatory agency. Nonetheless, the signal from the EQDM is clear: a justification can be made to replace the pyrogen test with a test for endotoxin.

Posted by Tim Sandle

China revises GMP


The China Food and Drug Administration (CFDA) has revised its good
manufacturing practices (GMPs) for medical devices. These developments affect all medical device companies that have their own manufacturing facilities or use contract manufacturers in China.

According to the National Law Review, under the recently revised framework regulation for medical devices, the Medical Device Supervision and Administration Regulation (MDSAR) and related implementing regulations, device manufacturers with production facilities in China are required to organize their quality control systems in accordance with device GMPs and other relevant mandatory device-related standards. 

Before obtaining the necessary manufacturing licenses for Class II and Class III devices, manufacturers must be inspected by provincial food and drug regulatory authorities for GMP compliance.  Thereafter, those manufacturers must periodically conduct their own self-audits of their quality control system and submit the self-audit report to the provincial level authorities.

Since the revisions to the MDSAR, CFDA has begun to focus more on GMP compliance and enforcement.  CFDA issued a short, basic set of device GMPs for “trial implementation” in 2009, but compliance and enforcement were problematic in some areas.  These issues were initially addressed in CFDA’s 2014 enforcement “campaign” for devices, referred to as the “Five Rectifications Campaign”.  During that campaign, provincial food and drug authorities targeted and inspected some of the higher risk facilities to resolve issues.

After the Five Rectifications Campaign, CFDA issued a notice in September 2014 calling for, among other things, all newly established device manufacturers and Class III manufacturers that added new sites or switched sites to come into compliance with device GMPs by October 1, 2014.  The notice also stated that all Class III device manufacturers must become compliant by January 1, 2016, and all device manufacturers must be compliant January 1, 2018.

Posted by Tim Sandle

Friday, 12 June 2015

Maturation of the Infant Microbiome


We now know more than ever before about the complex ecosystem of bacteria, fungi, and viruses within our bodies. How can that knowledge be best applied? Here is one example relating to infants.

"Like babies themselves, the intestinal microbiomes of infants start out in an immature state and over time grow into communities similar to those of adults. In a new survey of 98 Swedish babies whose microbiota were sampled several times during their first year of life, researchers found that the microbiomes of breastfed infants persisted in a “younger” state longer than those of non-breastfed babies, even after the introduction of solid foods", writes Kerry Gens.

In relation to this, The Scientist presents some interesting new research.

"Researchers from University of Gothenburg in Sweden and their colleagues found more adult-like taxa in the microbiomes of babies who stopped breastfeeding earlier, while the microbiota of babies breastfed for longer were dominated by bacteria present in breastmilk. The results, published in Cell Host & Microbe."

Posted by Victor Grayson

Thursday, 11 June 2015

Highly Potent Products – Dedicated Facilities



Malcolm Holmes has written an interesting review about changes to EU GMP called “Highly Potent Products – Dedicated Facilities.”

EU GMP Ch 5 -Changes have been made to sections 17 to 21, including adding a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment to determine safe threshold values of potential cross contaminants.

To access the article, see PHSS.

Posted by Tim Sandle