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Quality improvement plan

Quality improvement

Progress-PME can implement quality improvement programmes for its customers in Pharma & Biotechnology and in hospital environments. Tightened legislation and regulations and increasing competition in the market are forcing organisations in these sectors to monitor quality increasingly and to improve it where possible.

Quality improvement in a pharmaceutical filling department
Progress-PME helped the pharmaceutical filling department of a major organisation implement a quality improvement programme. End products are aseptically filled here, i.e. germ-free. After performing a GAP analysis to compare the existing situation with the desired one, an implementation plan was drawn up to supplement the identified shortcomings.

Implementation of the plan
In order to implement the improvement plan, internal training sessions were organised for the operators of this filling department. This considerably improved their GMP (Good Manufacturing Practice) level. In addition, the training plan for the department was rewritten. A specific training programme was developed for each process or sub-process. Implementing a planning system in which the operators are rotated over the various processes has also helped keep their knowledge and experience up to date. The department’s GMP documentation, including the batch documentation (documenting the production of a pharmaceutical product), operating instructions and logbooks was discussed in the teams and adapted where necessary. 

The result
The commitment of the operators regarding maintaining the quality level in the department increased significantly as a result of these modifications and interventions. We directly involved the operators in the investigation into the root causes of deviations and in the implementation of the resultant CAPAs (Corrective and Preventive Actions). Directly involving the operators and not introducing these changes as a top-down decision, increased commitment and support for the process. Additionally, a quality officer was appointed within the department to monitor the quality level and to manage and finalise the deviations and CAPAs on time. Positioning this job within the department has meant short lines and a constant focus on quality. This makes it possible to maintain the quality level and assess proposed improvements immediately.

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