European Pharmaceutical Review

MAY 29, 2023

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.

Process Improvement 95

Process Improvement Packaging Vaccines Drug Development 95

European Pharmaceutical Review

FEBRUARY 12, 2024

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.

Process Improvement 98

Process Improvement Packaging 98

GMPSOP

NOVEMBER 19, 2023

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.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

MARCH 17, 2023

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.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52