Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?

Abstract

<jats:title>Abstract</jats:title><jats:p>To assess the quality of centrally prepared cytotoxics a global approach is being implemented by pharmacists. A risk analysis is performed, and then many in-process controls are proposed. The aseptic process and the material are also fully validated. Moreover the skills of pharmacy technicians are being checked and monitored over time. This short opinion paper discusses the place of in-process quality control within the quality system applied to cytotoxic preparations. It also discusses the pros and cons of analytical control of the final product versus continuous control of each preparation step by eye witness or an electronic device such as a camcorder. Finally the relevancy of controls is discussed in function of different cases and of the human and material resources available in the pharmaceutical technology cytotoxic unit.</jats:p>

Simulation program of a cytotoxic compounding robot for monoclonal antibodies and anti-infectious sterile drug preparation

“…All in all, the reliable identification of drug and diluent coupled to gravimetric “in-process” control can advantageously and safely substitute the end-product analytical control as discussed by Lagarce. 28…”

Automation of Aseptic Sterile Preparation: Risk Analysis and Productivity Comparison with Manual Process

“…But analytical control is not available for all drugs leading to the need to implement per-process control. The benefits and limits of per-process and post process controls were extensively discussed by Lagarce [20], When per-process control is based on human double-check the reliability of the method is limited to 85 % [21] and encourages even for tailor-made preparations the use of robotic which integrates multiple per-process controls (camera recording and gravimetric control).…”

Quality Assurance in Hospital Pharmacy Compounding Units is a Multi Player Game

“…In fact, the direct environment of the preparations should be controlled (quality of air, chemical and microbiological contaminations) and the skills of the workers should be assessed. Many quality controls are also implemented during the process and on the final products to ensure their quality; for example on chemotherapeutics -see a review published in our journal earlier this year [1]. As stated in another editorial, the pharmacist is the key person for the quality of drug products in the hospital [2].…”

“…This highlights the issue of homogenization before the control. Moreover those techniques are still related to sampling, which can cause chemical contamination of the bench [1]. A pure Raman analysis can be performed through the drug container but is limited to a few drugs [6].…”