Available online 17 August 2022, 106275
AbstractAutomated compounding device (ACD) are increasingly used for parenteral nutrition (PN) bag production, and their acquisition must be sufficiently thought. The law requires the qualification of these ACD, but did not specify the tests to be performed. The quality by design (QbD) risk based approach allowed to define the quality target product profile in order to acquire the best ACD for each unit, and thanks a risk analysis permitted to define the critical quality attributes (CQA). These CQA will allowed to define tests performed during qualification. The ACD qualified was a 12 pump volumetric system. The CQA for PN bags consisted in sterile, precisely and accurately production with enough stability. During operational qualification volumetric accuracy test was performed, and during the performance qualification: flush volume, media fill, microbiological integrity of environment, sterility of control bag and production test were performed. At the end, all tests were conclusive (excepted for some results mostly due to analytical bias) and the ACD was considered to produce sterile bags in a control environment, precisely (relative standard deviation < 4%) and accurately (mean bias < 1% for weight and < 7% for other controls) with a sufficient stability. The QbD risk based approach allowed to acquire the best ACD for our need, and qualify relevant elements regarding the production process.
KeywordsTechnology Pharmaceutical
Qualification
Parenteral Nutrition
Quality by design
AbbreviationsACDAutomated compounding devices
CMAsCritical Materials Attributes
CPPsCritical process parameters
CQACritical quality attributes
EMAEuropean Medicines Agency
FDAFood and Drug Administration
ICHInternational Conference on Harmonization
IQInstallation qualification
OQOperational qualification
PQPerformance qualification
QTPPQuality target product profil
RSDRelative standard deviation
RSDrRelative standard deviation repeatability
RSDRelative standard deviation reproducibility
© 2022 Published by Elsevier B.V.
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