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Referenzpreissystem (RPS); Österreich hat aber bislang kein derartiges. System eingeführt. .. B. der Apothekenbetriebsordnung) notwen- dig, um eine. Apotheke in Wien Schwechat rkorn Flughafen Law: Apothekengesetz, Apothekenbetriebsordnung, Arzneimittelgesetz. You can review the various. Otto Pommer (Apotheker, Ausbildung in Österreich absolviert) Apothekengesetz, Apothekenbetriebsordnung, Arzneimittelgesetz, sowie die Berufssitte des.

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Is there an indication that the deadlines for the storing of freshly produced or freshly opened water in containers are adhered to? Likewise the treatment of tea-drugs is to be regulated operationally in a different manner.

Tragen von Handschuhen und Mundschutz3. Quality and test characteristics of pharmaceutical primary materials and preparations.

Pharmaceutical preparations of microbiological quality according to category 2 or 3. Only persons apothekenbtriebsordnung stay in preparation rooms and areas who perform corresponding activities.

Hygiene, Loseblattsammlung auf dem Stand der Has been ensured that the exterior surface of the containers with primary substances are cleaned or disinfected if required before bringing them into the preparation area?

The result of the hygiene measures should be proven by microbiological examination. Additional documents are the guidelines for the “Good Manufacturing Practice” of pharmaceutical products in the PIC-GMP-manual 17 and supplementing guidelines 18 for liquids, creams, ointments and other drug preparations as well as the guidelines for the Good Pharmacy Practice in Europe Hand disinfection is effected as so-called surgical disinfection stedreich working at the open product.


A separate operating instruction is to be established for the preparation, safekeeping and storing of water as drug component. Reinigung, Montage, Kalibrierung3.

In preparation areas only those devices and materials are to be kept which are necessary for manufacturing. Dokumentation der Reinigung, und 7.

Sensibilisierungspotential der Arzneimittel, 2. Das Personal darf nur entsprechend seiner Ausbildung und seinen Kenntnissen eingesetzt werden.

GD – Online | GD Hygoene Guideline | Print Version

For the preparation of sterile drugs and cytostatic agents additional measures are necessary. Has been ensured that reusable storage vessels are cleaned or disinfected if necessary before bringing them into the preparation area? It has to be in a condition as to space that the risk of microbial contamination is kept as low as possible, preparation premises are to be given preference. The waste containers should not be touched apothekenbetriebsirdnung preparation.

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Annahme und Kontrolle der Lieferungen der Arzneimittel und des Verpackungsmaterials, 2. Has been ensured that the preparation area is not used as opposed to the intended purpose? Area in which at a determined point of time a certain preparation activity is exclusively executed, e.

It has to be prevented that receptacles returned by patients might get into the preparation area. Has been ensured that non-pharmaceutical staff is equally included into the trainings regarding the hygiene concept?


Microbial contaminated products can perish and harm the user when applied. Has been ensured that no packs returned by customers get back into the preparation area? Cleaning of hands 2. Are the necessary scales according to question 7 available at the preparation area? Drug acts, pharmacy operating decrees and comparable legal norms of central European countries 4, 10, 16, 25, 26 demand a hygienically faultless condition of the preparation premises and controlled preparation processes.

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Is an operational hygiene plan concerning personnel hygiene available in writing? The microbial purity of different pharmaceutical preparations is defined by categories. When producing pharmaceutical preparations appropriate measures have to be taken in order to ensure their microbiological quality. Amtliche deutsche Ausgabe, Text 5. Dokumentation der Reinigung, und. Has a cleaning instruction in writing been elaborated for the water bath?

Is current specialized literature regarding industrial hygiene stereich

Im Sinne dieser Verordnung bedeutet: If interruptions cannot be avoided, open products have to be covered in an appropriate manner watch glass, film.