Products are often manipulated aseptically within aseptic compounding units, either under the terms of a Manufacturers Specials Licence or under Section 10 exemption of the Medicines Act 1968 (by or under the supervision of a pharmacist). This might be a single item for an individual patient, on a batch manufacturing basis (licensed units only), or something in-between, for example the preparation of a bulk fluid for packing of multiple doses for one or more patients.
For this product group there are various points at which quality control analysis as part of product quality assurance, process validation, equipment validation and operator validation, as well as product stability assessment and monitoring, can be considered. Furthermore, analysis may be required as part of investigations into patient incidents or where errors are suspected to have taken place during a preparation process.
The case studies presented within this document are examples only and should be subjected to local validation in accordance with standard assay validation procedures before being used for product analysis.