The suitability of good manufacturing practice (GMP) for the quality assurance of the preparation in hospital pharmacies is investigated. It is expected that the recent expansion of GMP with quality by design (QbD) and quality risk management (QRM) will significantly improve the applicability for all types of preparation in hospital pharmacies. QbD and QRM acknowledge the importance of targeting the need of the patient, of a good design and of risk assessment, thereby offering more flexibility to the hospital pharmacist to respond to everyday requests for patient care. For European hospital pharmacy an elaboration of GMP principles for specific preparation processes is desirable. The development of models for risk assessment will also be very helpful. The usefulness of the Council of Europe Resolution for these aims is discussed. This article aims to provide a small contribution towards a transparent, predictable though flexible and cost-effective pharmacy preparation.

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BackgroundIn Denmark, hospital pharmacies manufacture as well as buy unlicensed pharmaceutical preparations prescribed by physicians. Each Danish hospital pharmacy is responsible for manufacturing and supplying preparations within their own Region; however cross-Regional coordination is limited. This has resulted in a vast portfolio of unlicensed pharmaceutical preparations with possibly many duplications and similar preparations and with different or unknown clinical use, even though the clinical needs are similar throughout the country.PurposeTo identify a common national portfolio corresponding to clinical need by analysing and categorising the use of unlicensed pharmaceutical preparations from all Danish hospital pharmacies.Material and methodsThe study was a retrospective analysis of sales data from 2012 and 2013, which were collected from the electronic system of all Danish hospital pharmacies.The total sales data were analysed by 6 clinical pharmacists representing all major hospital pharmacies. The process was facilitated by a project manager.The clinical pharmacists categorised the existing portfolio according to preparation, formulation and indication. They identified identical preparations, alternatives and estimated the overall clinical relevance. The pharmacists consulted colleagues, physicians and guidelines to ensure broad and accepted categorization.ResultsA total of 2,754 unlicensed pharmaceutical preparations were identified in the existing portfolio. Of these, 739 preparations were considered to be of clinical relevance and should be included in the updated national portfolio of unlicensed pharmaceutical preparations.Indications were allocated to all 739 preparations.ConclusionA national portfolio of extemporaneous pharmaceutical preparations with corresponding indications was identified. The portfolio helps secure a unified content and use of unlicensed pharmaceutical preparations across Denmark, which potentially could lead to increased patient safety.References and/or Acknowledgements1Martin Høj, Emendo A/SNo conflict of interest.

BackgroundPreparation in Hospital Pharmacies aims at meeting special patient needs. In general facilities and equipment are intended for preparation of a variety of products containing a diversity of Active Pharmaceutical Ingredients (API). Cleaning validation has to be performed according to EU GMP, which requires limits for Maximum Acceptable Carryover (MAC) to be established based on toxicological evaluations. Furthermore, effectiveness of the cleaning has to be documented using validated methods of analysis.PurposeTo develop models for establishing limits for MAC in general, and for validating the cleaning of equipment used for the preparation of suppositories in particular.Material and methodsA model for establishing limits for MAC was developed in close cooperation with acknowledged toxicologists with experience from food science. The MAC was calculated based on toxicological evaluations and calculations of the total surface area of equipment.Riboflavin was found to be a suitable marker for API and a method was developed in order to detect any residues with a UV lamp. The method was tested for specificity, stability, reproducibility and accuracy. Limit of detection (LOD) was documented by testing a range of different concentrations of riboflavin for UV activity. For hot spots in the equipment it was furthermore documented, that any residues will be detected during the visual control with the UV lamp.Cleaning validation included preparation of a test batch with riboflavin replacing the worst case API. After production the equipment was cleaned using standard procedures. Subsequently visual control was performed and rinse samples from the equipment were analysed for UV activity.ResultsThe analytical method was validated and LOD was documented to be 0.05 µg/ml – significantly lower than MAC. Cleaning of equipment used for production of suppositories was successfully validated using the riboflavin UV analytical method.ConclusionExperience from food science can be used to establish limits for MAC. The riboflavin/UV analytical method is highly suitable for validating the cleaning of equipment used for suppositories.References and/or acknowledgementsNo conflict of interest.