Mit QbD und PAT die Qualitätskontrolle signifikant verbessern

Das Konzept des Quality by Design (QbD) zusammen mit den technischen Möglichkeiten der Process Analytical Technology (PAT) erlauben

ein besseres und rascheres Verständnis von Herstellungsprozessen pharmazeutischer Produkte.

Eine Freigabe mittels Real Time Release (RTR) beschleunigt die Freigabe. Mittels eines  risikobasierten Ansatzes auf wissenschaftlicher und technischer Grundlage können so Entwicklungs-, Herstellungs- und Qualitätssicherungsprozesse sowohl für Hersteller wie auch Überwachungsbehörden optimiert werden. Selbst die Sicherheit für den Patienten ist erhöht und eine Kostensenkung für das Gesundheitssystem erzielbar. Die technischen Voraussetzungen sind geschaffen. Regulatorische Vorgaben befinden sich entsprechend im Wandel. Die pharmazeutische Industrie ist gefragt die existenten Möglichkeiten zu nutzen. So lassen sich ständige Produktionsverbesserungen innerhalb des zuvor definierten Design Space ohne Änderungsmeldung umsetzen.

Ein besseres und sichereres Produkt sind das Resultat.

Zögern Sie also nicht, die Einführung des QbD Konzeptes vorzunehmen. Der temporär erhöhte Zeitaufwand zur Einarbeitung darf kein Hindernis mehr sein in Zeiten der steigenden Angebote externer, fachlicher Expertise (siehe beispielsweise www.pharmoveo.de).

Stress: When Motivation turnes into Burnout

Stress is a reaction securing survival in life threatening situations. A pulse of epinephrin is released. Many people state that their productivity is increased when they are under pressure. The epinephrin released allows for the energy to sustain a day when one appointment is following the other.

The positive stress created for exceptional cases however turns into negative stress if it is existing on a continuing basis. The motivation is lacking. Some of the physical effects it may have are headdaches,  anxiety and muscle cramps but also depressions, weight increase, heart diseases, drug or alcohol abuse and burnout syndroms can occur.

The first groundbreaking studies correlating stress to disease were published in 1967 by Thomas Holmes and Richard Rahe, two psychiatrists. They developed a ranking of stress producing events for adults. Starting with the death of the spouse and followed by divorce and separation a new orientation in the job was already factor number 15. Even though this is normally a positive change the tension and fear of the new situation are not to be underestimated stress factors.

Hans Selye, a stress researcher and physician (1907-1982) searched for physical reactions of stress. He differenciated into three phases following each other: alarm. opposition and exhaustion. The burnout syndrom does belong to the exhaustion stage. 

Prof. Dr. med. Joachim Bauer is an internal specialist and psychotherapist located in Freiburg, Germany. He describes the Burnout Syndrom by three characteristics that have to occur at the same time:

1. emotional exhaustion

2. low personal accomplischment

3. depersonalisation

For a person to perceive stress as a motivational factor again the primary goal is to reduce the work load. Delegation to co-workers and the outsourcing of work are two effective and readily available tools to achieve immediately a significant effect. That the outsourcing can be suitable even for persons in higher positions can be seen when looking at companies offering high level expertise on temporary basis e.g. www.pharmoveo.com.

If then the time gained is used to be physically active e.g. to jog, to visit a fitness center, to swim the negative effects of stress onto the body can be released faster. The combination with relaxing activities that produce enjoyment will allow the body to get back into the necessary balance.

The Invention of the Electron Microscope

The invention

The development of the electron microscope (EM) was based on the discovery that a magnet coil may function as an optical lens. After having shown in his thesis of 1929 that sharp and magnified images of electron-irradiated hole apertures could be obtained with the short coil, Ernst Ruska was now interested in finding out if such images could be further magnified by arranging a second imaging stage behind the first stage. Such an apparatus with two short coils was easily put together. In April 1931 Ruska obtained the definite proof that it was possible. This apparatus is justifiably regarded today as the first electron microscope even though its total magnification of 3.6 x 4.8 = 14.4 was extremely modest.

The type of microscope designed by Ruska is called transmission electron microscope. The electron beam passes through the specimen being observed that must be sufficiently thin. The resolution of EMs is considerably higher than the resolution of light microscopes since the wavelength of the used electron beams is 10,000 times lower than that of light. Conventional light microscopes have a resolution of about 4,000 Å (1 Å, Angström = 10-8 cm), whereas EM resolution averages 1 Å.

Ruska left the university to pursue his research in the field of electron optics in industry and joined Siemens & Halske, where he developed an electron microscope together with Dr. Bodo von Borries. This serially produced EM was put on the market in 1939. Ruska considerably improved the research tool over the years. In 1986 he was awarded the Nobel Prize in Physics together with Dr. Gerd Binning and Dr. Heinrich Rohrer.

 Ernst Ruska once said that “… occasionally it can be more a matter of luck than of superior intellectual vigour to find a better – or perhaps the only acceptable way”. It maybe that one or the other research performed in Your lab contains inventive steps? Support with respect to pharmaceutical patent inventions one will find at www.pharmoveo.de.

Biography

Ernst Ruska was born 1906 in Heidelberg, Germany. He is the son of a professor. In 1925, Ruska took up studies in electrical engineering in Munich, which he pursued in Berlin two years later. From 1928, his studies at the Hochspannungsinstitut (institute of high voltage technology) focused on high voltage and vacuum technology. At that time, he discovered the basic principle of electron microscopy. He joined a project group headed by Dr. Max Knoll. This group built the first functioning electron microscope in 1931. For the first time, sharp images were obtained by means of electron beams. In 1933, pole shoe lenses developed in cooperation with Dr. Knoll allowed to obtain the first images magnified 12,000 times, surpassing the resolution capacity of the light microscope. In the same year he gained his doctorate. From 1949 to 1971 he gave lectures at the Freie Universität and Technische Universität of Berlin. In 1955, he left Siemens & Halske AG to become Director at the Institut für Elektronenmikroskopie (institute for electron microscopy) of today’s Fritz-Haber-Institut of Max-Planck-Gesellschaft. Prof. Dr. Ing. Dr. h.c. mult. Ernst Ruska died in Berlin 1988.

There is a website on his person with more detailled information e.g. the text of his nobel lecture. There is also a book published on his memoires. More information on the inventions he made can also be found on the website of the German Patent and Trademark Office.

 

Does the shortage of skilled employees also hinder growth within the pharmaceutial industry?

The health care industry is in good shape. The main reasons for that are the generally positiv economic develoment and the growing awareness of a healthy life style within the general public. This has a positive effect on the demographical change. Therefore this sector is still the driving force in the employment development within Germany.

After tough years in 2008 and 2009 the German pharmaceutical industry looks at a continuously positive economic trend since 2010. This positiv trend is also reflected in the investment plans of companies.

 

Negative impacts however which need to be controlled in the future are:

1. economical political decisions e.g. how to control the national debt within Germany as well as in the EU

2. the development of prices for energy and raw materials

3. growing expenditures on wages e.g. due to increasing numbers of full time employees (FTE)

4. shortage of skilled employees e.g. in Germany 43 percent of all companies within the health care industry consider this already a significant business risk for 2012.

 

To maintain the necessary amount of skilled employees at the company gains more and more significance.

One possibility companies rely on is to increase the overall amount of  people being educated within the company. 

Another strategy is to establish processes in order to maintain the employability of the existing staff. 

Health preventing activities are offered.

Concepts are desigened to allow for a better work life balance.

More often the expertise of specialists working as freelancers is used in order to reduce the work load in peak periods and to prevent the existing full time employees from burnout situations. One example on how specialized freelance activities can be requested these days can be seen at www.pharmove.com