Resolution on pharmacy preparation

The pharmaceutical art of preparing medicines should be seen in the social context of guaranteeing the availabihty of necessary medicines to patients. The Cotmcil of Europe Resolution on pharmacy preparation considered the preparation of medicinal products in pharmacies as indispensable for accommodating the special needs of individual patients in Europe. 

The European Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients [2] describes the following list of topics to be covered in a product file, depth and interpretation depending on a risk assessment (see Sect. 21.6.3) ... 

For the quality management of therapeutic assessment of the physician s request and formulation design (two other processes of pharmacy preparation s life cycle), no reference is made other than to professional respruisibility and education. In this way, the Resolution (and thus its example model for a risk assessment) is rather unbalanced, because too much is focussed on the preparation process itself. 

It is considered as a GMP for pharmacy preparation, has a GMP-like stmcture and starts from the same principles. It is easier to read than the GMP because details not referring to pharmacy preparation are left out Deviations from GMP (for instance in Annex 1 on Sterile Preparation) are however not explained. It was developed before the CoE Resolution (Sect 35.5.4), which refers to it, or the Ph. Eur. monograph (Sect 35.5.3). The Resolution Umits the use of PlC/S GPP to less critical products . 

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