Workshop 1: Quality Management within a unit pharmaceutical technology: Feedback for an ISO certification
The implementation of a quality management system within a PUI is an integral part of the pharmacist’s tasks and pharmacist technician (BBP 2001). This is why it is essential to put in place a participatory documentary system accessible to all so that all the documented information required for the operation of a unit, including technie, are guaranteed and traced.
The involvement of non-medical and medical personnel in the writing, editing and changing reference documents (operating manual, procedures, records) is a key element for their adherence to the requirements for this activity but specific to each unit of production.
Upon arrival of a new member in the team, their training includes being based on data written and validated by the whole team to avoid any deviation in the desired expertise and therefore enable repeatability inter agent in the described task. Training should it even be an integral part of the quality management system being described, mapped and evaluated regularly.
We propose in this workshop to share our ISO 9001 certified unit experience: V2008. We suggest participants to share about a quality management system through a writing circuit, validation and monitoring of data documented in a technie unit to give each key facilitating initiation of an ISO 9001 certification.