Linked to EAHP Statements
Section 1 - Introductory Statements and Governance: Statements 1.2, 1.3
Section 3 - Production and Compounding: Statements 3.1, 3.2, 3.3, 3.4, 3.5
Section 5 - Patient Safety and Quality Assurance: Statements 5.2, 5.3, 5.9, 5.11
In 2016 the EU updated their resolution on quality and safety for medicinal products prepared in pharmacies, which defines the standards for the art of compounding. Just like the pharmaceutical industry has to comply with Eudralex GMP, the medication prepared in the hospital pharmacy must meet the requirements of Good Manufacturing Practices (GMP) or Good Preparation Practices (GPP), also known as PIC/S PE009-04 and PIC/S PE010-04. The goal of this resolution is to close the gap between pharmacy and industrial preparations and to lower the variation between the member states.
Therefore, hospital pharmacists started to invest in a better preparation environment but many of them underestimated the scope of a quality management system (QMS). It takes more than just a validated cleanroom with a high-tech air treatment system to deliver a quality product.
All steps in the processes should add to the quality and safety based on a risk assessment and a plan-do-check-act cycle (PDCA). The personnel must be adequately trained. The environmental parameters (temperature, humidity, pressure, number of particles, ...) must be controlled. Follow-up on bioburden (air sampling, sedimentation plates, Rodac plates, ...), operator skills (fingerprints, media fills, video training, ...) and quality of the raw materials and final products is mandatory. And for batch productions a full product dossier is a requirement.
Besides the positive impact on the quality of the preparations, all these measures result in a higher operational cost and a longer lead time for this service. Therefore, hospitals must standardise their formularies and start to cooperate in networks to keep compounding cost-effective. All this requires prescribers to think and work differently. As not every personalised preparation is available on the fly. Other galenic formulations, dosebanding and standardized formularies might bring solace to guarantee better care. But how far can we go and when does one become a manufacturer instead of a compounding hospital pharmacist?
This seminar will focus on requirements, opportunities, limitations, affordability and on a pragmatic approach of GMP/GPP in a hospital pharmacy.
After the session, participants should be able to:
• understand the requirements of GMP and GPP;
• describe the impact of a GMP/GPP quality management system on a hospital pharmacy;
• discuss the opportunities and limitations of GMP/GPP in the hospital pharmacy.
Education need addressed
Preparations in the hospital pharmacy must meet the high-quality standards of GMP/GPP. Therefore, the hospital pharmacist must understand the requirements and must be able to discuss the opportunities, limitations and the affordability for each hospital.
Keywords: GMP, GPP, quality management system, preparation, compounding, affordability, cost-effectiveness, standardization, dose-banding, hospital network, quality assurance, regulation.