Background One of the main missions of our Pharmacy Department at the Lausanne University Hospital is to ensure a steady supply of pharmaceutical products. Thus, if some medicines are not commercially available, it is mandatory for the Pharmacy Dept to manufacture them. Batch preparation implies the use of raw materials (RMs) and primary packaging material (PPs) which must comply with Good Manufacturing Practice (GMP).
RMs and PIs are acquired from suppliers authorised by SwissMedic (Swiss agency for therapeutic products). Any change in the supplier of an RM or PI can affect the preparation process, resulting for example in batch rejection.
Purpose To enforce change control and management for PPs and ensure conformity with our preparation specifications.
Materials and methods We introduced appropriate PP controls and performed three Product Quality Reviews (PQRs).
Results Within a period of three months prior to the implementation of quality control for PPs, two batches were rejected, caused by a lack of conformity to specifications. One case involved a high density of particles in infusions, while the other resulted from a change in the volume of suppository alveoli. A total of 118 checks have been carried out since September 2012 following the implementation of PP controls. A single non-conformity has been evidenced. Three PQRs were carried out in 2013, one of which focused on the manufacturing of suppositories.
Conclusions The introduction of systematic checking of PPs and performing PQRs have resulted in improved critical change control and management, avoiding batch rejection.
No conflict of interest.
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