GRP-044 Conformity of the Batch File in Preparation: An Internal Audit

Background Around 3000 batches of medicinal products are prepared each year in Lapeyronie Hospital. For each batch, a batch file (BF) is created. This contains the prescription, a manufacturing and labelling sheet (MLS) and a control and batch release sheet (CBRS). Purpose Since the publication of the French Good Manufacturing Practice in 2007, a process of quality improvement has been implemented. An internal audit of all 2011 BFs has been conducted to evaluate the non-conformity (NC) rate. Materials and Methods An internal control questionnaire (ICQ) evaluating various criteria was written by the pharmacist and completed by students and residents for each BF. The results were compared with a previous 2010 study. Results 42% of 2,858 BFs were not acceptable. There were 1691 non-conformities (a BF can be unacceptable on several criteria): 32% of the unacceptable BFs had a problem with the prescription, 59% had inaccuracies with the MLS and 9% with the CBRS. Of those with prescription problems, pharmaceutical validation traceability was lacking for 49% and 31% had not been signed by the MD. The absence of checking the sheet before preparation was the major NC factor (79%) regarding the MLS. The volume of raw materials was not checked during preparation in 8.6% of MLS. NC regarding CBRS was due to incomplete checking of the preparation before it was released (36%). Results in these 2 studies showed that the MLS was not checked before preparation in 28% of BFs in 2011 against 71% in 2010. The volume cheque before preparation was not performed in 41% of BF in 2011 against 85% in 2010. Conclusions Following this audit, corrective actions were instituted: pharmacists were trained on the importance of the pharmaceutical validation of prescriptions, and the assistants were reminded of the importance of getting their work checked before and during preparation. Nevertheless, there has been progress in the conformity rate between these two audits, pointing out the impact of corrective actions. No conflict of interest.