Certified compounding pharmacy
Management System as per ΕΝ ISO 9001 : 2015
for the scope of Pharmaceutical Compounding
The lab
Our pharmacy’s laboratory was constructed in the first half of 2012 following the modern standards for the creation of laboratory spaces for the preparation of medicinal products.
It has been certified by TÜV AUSTRIA since 2018 for the Management System according to the Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (1 June 2016) and also as per ΕΝ ISO 9001 : 2015 for the scope of Pharmaceutical Compounding. It is a Grade D clean room with ISO 8 classification.
The lab has a positive pressure of 10-15 Pascals with 20 air changes per hour through a HEPA filtration system. Environmental conditions like temperature and humidity are controlled and monitored. The work areas, equipment and utensils are suitable for the manufacturing of medicinal products and are cleaned at the end of each manufacturing process using procedures outlined by strict protocols. The laboratory area is subject to periodic inspections to certify the absence of microbial load.
Cutting edge equipment
The equipment is suitable for the preparation of medicinal products. It is routinely maintained to ensure its proper functioning. Measuring, weighing and control equipment is calibrated as well as checked for correct function and re-calibrated by certified partners at appropriate intervals.
Active pharmaceutical ingredients, excipients and containers used in the preparations are sourced from GMP-certified suppliers and are accompanied by a Certificate of Analysis or a Declaration Of Compliance as appropriate. They are stored in a controlled environment, at a specified temperature and humidity range. All the necessary technical and organizational measures are taken to avoid cross contamination during production.
Our laboratory personnel is trained in all areas that are necessary for the fulfilment of their duties, upon recruitment and on a regular basis. Their continuing education is documented.
All stages concerning the preparation, the operation of the laboratory and the handling of raw materials and finished preparations are described by well documented standardized instructions in order to ensure both the quality and safety of the finished products and the safety of the personnel.
Production planning is carried out by the Responsible Person, a highly trained pharmacist, based on existing scientific literature, through subscription to authoritative international online libraries and journals such as CompoundingToday.com, International Journal of Pharmaceutical Compounding, Fagron Academy Compounding Technical Services . The Responsible Person is ultimately in charge of the quality of the medicinal products prepared and released and ensures that they comply with the valid specifications and that they have been prepared in accordance with valid procedures and with the Principles of Good Preparation Practices. The actual release is delegated to the Release Officer.
The above steps have been automated and optimized to such an extent that all critical control points meet the four eye principle (double-check rule), minimizing the possibility of human error.
