Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

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Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction. Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

The European Federation of Pharmaceutical Industries and Associations (Efpia) said a survey of its members showed 45 percent of companies expected trade delays if Britain and Europe fell back onto World Trade Organization rules after Brexit. Drugmakers also face an additional hurdle when it comes to licensing their products, since more than 12,000 medicines will require a separate UK licence in order for them to be prescribed. “For life-saving and life-improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU,” said Efpia Director General Nathalie Moll.

Pharmaceutical companies have insisted since last year’s Brexit referendum that a comprehensive agreement is needed to ensure maximum alignment between EU and British pharmaceutical regulations. But with the clock ticking down to Brexit in March 2019 with no sign yet that a trade deal will be concluded, many companies are now starting to draw up plans to protect drug supply chains, including building extra testing centres in Europe.

 

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Brain Activity and Good Diet May Prevent Insomnia-Related Depression

Brain Activity and Good Diet May Prevent Insomnia-Related Depression
While lack of sleep is a major risk factor for depression, not everyone who tosses and turns at night becomes depressed. According to a study, individuals whose brains are more attuned to rewards may be protected from the negative mental health effects of poor sleep. The findings revealed that students with poor quality sleep were less likely to have symptoms of depression if they also had higher activity in a reward-sensitive region of the brain.”This helps us begin to understand why some people are more likely to experience depression when they have problems with sleep,” said Ahmad Hariri, Professor at the Duke University in North Carolina, US. “This finding may one day help us identify individuals for whom sleep hygiene may be more effective or more important,” Hariri added.

For the study, appearing in The Journal of Neuroscience, the team examined a region deep within the brain called the ventral striatum in 1,129 college students. Ventral striatum helps regulate behaviour in response to an external feedback as well as reinforce behaviours that are rewarded, while reducing behaviours that are not. The results showed that those who were less susceptible to the effects of poor sleep showed significantly higher brain activity in response to positive feedback or reward compared to negative feedback.

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The effects of poor sleep showed significantly higher brain activity

“Poor sleep is not good, but you may have other experiences during your life that are positive. And the more responsive you are to those positive experiences, the less vulnerable you may be to the depressive effects of poor sleep,” Hariri said.

 

Read More: http://snip.ly/ttax2#http://food.ndtv.com/health/brain-activity-and-good-diet-may-prevent-insomnia-related-depression-1753267

Pharmaceutical companies gave $12m to doctors, nurses and pharmacists

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Pharmaceutical companies gave Australian doctors, nurses and pharmacists almost $12m in fees and expenses to attend conferences and give talks between November 2016 and April 2017.

The payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.

The drug companies Bristol-Myers Squibb and Amgen both spent more than $1m over the six months and one doctor received more than $39,000.

Health economists Prof Philip Clarke from the University of Melbourne and Dr Barbara de Graaff from the Menzies Institute for Medical Research in Tasmania conducted an analysis for Guardian Australia on the $11,667,253 in pharmaceutical payments made to healthcare professionals.

Under the updated Medicines Australia code of conduct, pharmaceutical companies were required to disclose all payments made to healthcare professionals by 29 August. Previously, this disclosure required the consent of the health practitioners, which in many cases

 

Read More information: http://snip.ly/mulqf#https://www.theguardian.com/australia-news/2017/sep/12/pharmaceutical-companies-gave-12m-to-doctors-nurses-and-pharmacists

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

 

Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on ignorance, come in the way of proper implementation of effective water systems. When myths and hype surround these systems, it is but natural that they are doomed to failure.

Those in charge of pharmaceutical biofilms, more so those who deal with water systems need to be aware of all the aspects of water systems if they have to avoid failures. Lack of it can result in costly system downtime or even product recalls. It can result in costly system downtime or even product recalls.

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems3

Pharmaceutical biofilms, especially those in water systems, thrive on fear and hype. No long term biofilm control can be achieved using a one-size-fits-all set of rules for design and operation. Biofilm can be controlled only when it is fully grasped. This is all the more important because each water system is unique. Water systems professionals need to get to the root of how biofilm grows into their system, which, obviously, would be quite different from any other system.

This is why those in water systems need to have proper insights into what actually lies behind some common water system designs. They need to clear the air about several misconceptions on the topic.

Solid understanding of water systems

It is to clear these myths and misconceptions that the world-acclaimed guru of water systems, Dr. Teri Soli, will be presiding over a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. He has authored the complete rewrite of USP Chapter 1231, which many consider to be USP’s “pharmaceutical water bible”.

Want to understand the ways of implementing a water system that fulfils the conditions set out by the regulatory agencies? Just log on to All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems to enroll for this highly practical and useful seminar. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Learning on all aspects of water systems

In this microbiology-focused education about all aspects of water systems, Dr. Soli will offer knowledge of the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.

This interesting and interactive session will give participants insights into what actually lies behind some common water system designs and will bust a few myths about the same. The learning imparted at this course will is translatable to any system, with the result that uneventful microbial control can be achieved. This is the foundation to effective operation and design. Without this understanding, participants will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far outweigh the educational costs that could have prevented it.

Knowledge of water system validation and Change Control

A good way to get understanding of this topic is to be familiar with water system validation and Change Control. This knowledge is necessary to help them come up with ways of improving outcomes and reducing the frequency of excursion investigations. Dr. Soli will offer understanding on this at this seminar.

Dr. Soli has set out the following agenda for this seminar:

  • What makes water systems have microbial quality problems
  • Successful sanitization approaches for trouble-free water quality
  • Water system validation by logic instead of tradition
  • Understanding and controlling endotoxin
  • Harmonizing vs optimizing water microbial testing for system quality control
  • Microbial enumeration issues with high purity water systems
  • Water system investigation “how to’s” and example case studies
  • What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues.

Validation of Pharmaceutical Water Systems

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Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals.

A very important reason for which validation of pharmaceutical water systems is necessary is that water is not only the most widely used raw material or substance in pharmaceuticals; it is also put to a number of uses in the pharmaceutical industry, such as Quality Control, process, production and formulation. Further, water comes with its own set of unique chemical properties that are obtained because of the hydrogen bonds present in it and its polarity. This makes water versatile, since it allows the dissolution, absorption, adsorption or suspension of various different compounds.

Process for pharmaceutical water systems validationvalidation-of-pharmaceutical-water-systems

Validation of pharmaceutical water systems is carried out in three phases:

Phase I, which is the investigational phase

Phase II, the short term control phase, and

Phase III, which is the long-term control phase

Pharmaceutical water systems are validated through these three steps or stages to demonstrate and ensure that the facility using pharmaceutical water systems has water under its control and is on the right track for production of the right quality and quantity of water in the short, medium and long terms.

Validation through commissioning and qualificationPharmaceutical water systems validation is carried out through two important steps, namely commissioning and qualification. Commissioning is about putting the validation of pharmaceutical water systems through the required phases using the prerequisite methods of documentation. This documentation is a core part of pharmaceutical water systems validation because it allows for different personnel in the organization to not only keep track of the processes involved, but also make changes when necessary.

Qualification as part of pharmaceutical water systems validationQualification is the next important stage of pharmaceutical water systems validation. Here, before a pharmaceutical water systems validation process is started, the pharmaceutical facility should implement the following important steps:

  • Design qualification (DQ)
  • Installation qualification (IQ) and
  • Operational qualification (OQ)

Phase I:In Phase I, the pharmaceuticals facility samples and tests water sampling for anywhere between two and four weeks for monitoring the water system. If the water system is free of failure during this phase, it is considered a successful phase of pharmaceutical water systems validation.

Phase II:In this phase of pharmaceutical water systems validation too, the water system sample is tested intensively for two to four weeks, during which the water sample should show that it is producing the right quantity of water under conditions of stated SOP.

Phase III:Phase III of pharmaceutical water systems validation is the longest and most arduous period, running to one year after completion of Phase I and Phase II. When the water sample passes through this phase, it is said to have completed the process of pharmaceutical water systems validation and is considered fit for pharmaceutical use.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900882SEMINAR?wordpress-SEO

Investigations in Pharmaceutical Water Systems

nvestigations in pharmaceutical water systems are very critical for pharmaceutical organizations and laboratories. They can mean the difference between compliance and noncompliance. In many cases, organizations can get hauled up by regulatory authorities for failing to carry out proper investigations into pharmaceutical water systems.

The most common problem encountered by pharmaceutical and biotech companies and laboratories is microbial excursions. Investigating and handling excursions is the key to success in pharmaceutical water systems investigations.

Understanding excursions

So, what are water systems microbial excursions, and why do they appear so intimidating? In the simplest terms, microbial excursions may be defined as environmental data that is at par with or above established action limits for the regulated area. This means that in samples of water that fail to pass excursion tests, there is a certain level of contamination of the water systems in pharmaceutical and biotech organizations. Of course, it has to be borne in mind that the purity expectations and requirements are quite high compared to the water normally used by humans.

Why this is so is that pharmaceutical water systems are those that are used in the manufacture of drugs and pharmaceuticals; hence, even a small deviation from the prescribed levels of purity can have a major impact on the final outcome –the drug quality.

What can be done about excursions, then?

Having said this, excursions are not necessarily evil. Understanding whether excursions are from water, soil or from humans gives a good indication of the nature of excursions, which in turn give researchers a good idea of the nature of problems in the environment around them.

In many cases, wrongly designated trigger values, use points or wrongly selected and executed sampling and testing –and seldom excursions in themselves –are the culprit. So, pharmaceutical water systems and biotechnology organizations, laboratories and utility operations need to get their sampling right if they have to get to the root of the problem. This will help them avoid the huge costs associated with wrongly carried out investigations into pharmaceutical water systems.

 

References:

http://www.who.int/water_sanitation_health/emerging/info_sheet_pharmaceuticals/en/

http://electroiq.com/blog/2003/03/a-practical-guide-to-the-investigation-of-microbial-excursions/

 

 

 

The all-important nature of validation of pharmaceutical water systems

The significance of validation of pharmaceutical water systems can be gauged from the fact that among the number of substances, raw materials and starting materials used in the production, processing and formulation of pharmaceutical products; water takes a position of primacy. This is because the hydrogen bonds that water has, along with its polarity, lend it a set of special chemical properties. Because water has these attributes; many different compounds are able to blend with it in the form of dissolving, absorbing, adsorbing or suspension.

Yet, there is an irony, because this very unique quality of water –of its being able to blend easily –which makes it so important, also makes it a magnet and breeding ground for many contaminants. Water can meld different compounds, as well as contaminants. This is why effective and proper validation of pharmaceutical water systems is necessary and important.

Approaches to validation of pharmaceutical water systems

Validation of pharmaceutical water systems can be approached in three ways: prospective, concurrent and retrospective.

As the names suggest, prospective validation of pharmaceutical water systems is the validation that is carried out when an altogether new product is about to be introduced, or when there is a change in the process, which is likely to impact the attributes of water in the pharmaceutical product.

Concurrent validation of pharmaceutical water systems is the one that is carried out during the manufacturing process.

Retrospective validation of pharmaceutical water systems is one that is carried out after the product is out it the market. This is usually carried out when the company receives complaints about the product quality.

References:

http://www.authorstream.com/Presentation/aSGuest114007-1189653-water-validation/

http://www.bioline.org.br/request?pr10011

 

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