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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. It provides tools for the process improvements using robotics, which is well-established in other manufacturing sectors. Tanzini et al.

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How to conduct product quality review in pharmaceutical

GMPSOP

Trending will help identify product and process improvements. Component quality A review of all starting materials and primary packaging in contact with the product should be completed. Control limits should be established and justified through trending. Graphical representation using control charts is used to identify trends.

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Biologics – manufacturing trends in a modern facility

European Pharmaceutical Review

These innovative technologies include highly automated, fully digitalised process analytics technologies (PAT) , as well as automated and robotic testing technologies to confirm product quality. The complex and intricate processes involved in upstream and downstream manufacturing are highly refined, he notes.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

Corrective and preventive actions are identified and implemented as the outcome of investigations such as deviations, product complaints, internal audit observations, risk assessments, stability failure, or other process or system-related non-conformances. The entire unused packaging lot which was quarantined was returned to the supplier.