European legislation for aseptic manufacturing is developed with a particular focus on the pharmaceutical industry. With certain exceptions, manufacturers of human medicines are required to hold a Manufacturer’s Authorisation. To obtain an authorisation to manufacture medicinal product, compliance with the principles of Good Manufacturing Practice (GMP) must be demonstrated.
Aseptic compounding in Irish hospital pharmacy is exempt from holding a Manufacturer’s Authorisation provided certain criteria are met (Medicinal Products (Control of Manufacture) Regulations, 2007. Section 5 – S.I. No. 539 of 2007). However, the ethos of GMP is equally paramount to ensure that all products compounded are of high quality, safe and effective. It is important, therefore, that the underpinning principals of GMP can be translated transparently and safely into the hospital pharmacy aseptic compounding unit.
In the absence of nationally agreed guidelines for aseptic compounding in Irish hospital pharmacy the Hospital Pharmacist Association of Ireland (HPAI) submitted a project to develop guidelines to the Medication Safety Forum in 2010. All pharmacy departments with compounding facilities were invited to contribute. Through consultation with the Health Information and Quality Authority (HIQA) and the Irish Medicines Board (IMB), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010/3) was chosen as the most appropriate guidance to apply to aseptic compounding in Irish hospitals.
These guidelines were written by pharmacists working in aseptic compounding and reflect a consensus of the combined knowledge of these pharmacists. They are guidelines of professional practice as developed by practitioners and have been endorsed by Chief Pharmacists (Head of Departments) on 7th March 2013 and by the HPAI Executive on 7th November 2013.