quality-risk pat 
European Pharmaceutical Review
SEPTEMBER 8, 2023
The section on environmental monitoring (EM) in Annex 1 states that “The adoption of suitable rapid or automated monitoring systems should be considered by manufacturers in order to expedite the detection of microbiological contamination issues and to reduce the risk to product”.
European Pharmaceutical Review
AUGUST 2, 2023
The proposed autonomous process analytical technology (PAT) platform comprises of a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) for use in the laboratory as an off-line analytical system and on the manufacturing floor. How was the autonomous PAT platform designed?
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European Pharmaceutical Review
JULY 20, 2023
Research published in Processes has reported the first successful establishment, validation and integration of a digital twin with process analytical technology (PAT) operated autonomously for biologics manufacturing. The paper noted that process monitoring and product quality assurance are implemented using a wide range of measuring sensors.
European Pharmaceutical Review
MAY 3, 2023
For instance, digital biomanufacturing, also known as digital bioprocessing, has become promising in helping to improve process robustness and drug product quality. Examples include process analytical technologies (PAT), data analysis software (DAS), manufacturing execution systems (MES) and digital twins. technologies. services.
European Pharmaceutical Review
OCTOBER 20, 2022
Monitoring water quality: how representative and accurate are water samples? The goal when monitoring water quality is through a sample(s) – and sub-samples thereof – to obtain a representative and accurate description of the quality of water system in question. Water quality from an Annex 1 and Pharma 4.0 perspective.
pharmaphorum
DECEMBER 29, 2022
In times of accelerated process design, pharma companies must drop manual workflows that risk clerical errors and data integrity violations. Digital batch execution management, electronic lab notebooks, and factory dashboards can remove risk from these error-prone processes.
Quality Matters
SEPTEMBER 15, 2023
For certain drug substance and drug product manufacturing processes, PCM can bring opportunities to enhance flexibility and efficiency, lower production costs, cut environmental footprints, accelerate scale-up when needed, improve process control, and reduce potential quality issues, workshop participants reported. Why is continuous better?
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