The mountain pharmacy becomes manufacture enterprise in the new premises

The mountain pharmacy Tecklenburg established new production areas at the location in Ibbenb�ren, in order to follow so the increased demand for their products and services. In connection with the removal from Tecklenburg to Ibbenb�ren a manufacture permission was given at the same time after AMG �13 by the district government M�nster.�� �The mountain pharmacy supplies established physicians as well as patients directly for several years with most diverse drugs in application manufacturer form. In addition count cytostatic drugs, parenteral nutrition, pain cartridges and Ophthalmika. The demand for these preparations constantly rose in the letzen years, so that the management decided the manufacturing areas in Tecklenburg before two years due to the missing expansion possibilities to give up and at the existing location in Ibbenb�ren new and concomitantly additional manufacturing areas to create. As planning partner one decided for the Carpus process expert GmbH. Together with a local resident architect the Carpus process expert planned the new production areas the inclusive mechanisms installed there in such a way that the current EU-GMP requirements, in particular those appendix of the 1 is completely fulfilled. A goal was it to receive a manufacture permission after AMG. For this further measures had to take place like e.g. the structure GMP fair quality management systems. Planning and the approach with the qualification and validation were promptly co-ordinated with the responsible authority, then it could be guaranteed that an appropriate acceptance was given to inspectors by the responsible persons. Altogether approx. 500m were established � to pure area of the classes D and B in an existing building. Apart from the installation of ground, walls and covers and the associated air-lock systems the installation of the ventilation was due to the small Deckenh�he of 3m a special challenge. Thus became all armatures, which are subject to regular maintenance easy to service from the outside accessible installed (outside of the pure class of area B). For the aseptischen manufacture steps, which have to take place in the pure class of area A, 8 new LF of work benches were planned and realized. There the mountain pharmacy both CMR preparations (carcinogenic, mutagen and reproduction-toxically) and not CMR preparations processed were created two strictly from each other separated ranges. For the two ranges separate ventilation systems were installed and separate personal and material locks were furnished. Thus the risk of a cross contamination can be excluded surely. �Within the two ranges over an appropriate compression phase concept � the Clean so called Corridor is realised � principle. Hereby a cross contamination is excluded within the ranges by displaced person between the individual manufacture areas. With this concept the passage is held on a higher pressure level than the adjacent production areas of the same pure class of area by the common use of the secondary functions as preparation, cleaning and storage, which are accommodated in areas of the pure class of area D, could the necessary place be optimized and so sufficiently area for the individual manufacture steps be created. When planning of the air-lock systems particularly on functionality and the avoidance of kidnapping of microorganisms one respected. Thus it is guaranteed that the micro-biological requirements of the respective pure classes of area are kept surely. For the monitoring of the hygenic conditions a computer-assisted Monitoringsystem was installed, which seizes and supervises the particles in the pure class of area A and the pressures within the entire manufacture range continuously. Beyond that a micro-biological monitoring was established, which was to guarantee that the respective hygenic requirements are kept. All GMP of relevant systems was risk-basedly qualified in accordance with appendix 15 to the European Union-GMP-manual and the appropriate procedures (sterilisation, production) were validated. All measures specified above had the technical Vorraussetzungen as a goal to create a manufacture permission after AMG �13 to receive. Additionally by CPE as well as the mountain was compiled pharmacy a GMP conformal quality management system. This contains among other things. the necessary � systemic � work instructions (SOPs) like a CHANGE control procedure, treatment of deviations, qualification or production GMP of fair documentation. Beyond that a Site master file (SMF) was provided, which describes the entire enterprise upon the associated organization and the expirations in short form. By the example the mountain pharmacy becomes clear that when accordingly professional planning and direction of the project complex projects can successfully i.e. in time and cost-optimized be completed. The distribution of manufacture permission after a successful GMP inspection by representatives of the district government represented conclusion of a good co-operation between the Carpus process expert and the mountain pharmacy. Andreas Nuhn, Katrin Bredohl

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