Your firm has not conducted smoke studies nor media fills under dynamic conditions in rooms C704, and C706 where filling
Your firm has not conducted smoke studies nor media fills under dynamic conditions in rooms C704, and C706 where filling
Specifically, there is a failure to validate the endotoxin sample storage of drug products under project code *** at ***
The designs of Vial Line *** systems ( ***), Vial Line *** (System ***), Flexible Fill Line *** (System ***),
The ability of visual inspectors to identify integrity defects during visual inspection of ** Restricted Access Barmier System *** RABS)
There is no disinfectant efficacy study performed for *** tubing used for drug product transfer during vial filling on ***
*** Nonviable Particle Counters, Model Number, 3423, Equipment ID No. PR-NVPCP-001, PRNWCP-002, PR-NVPCP-004, lack the functionality to save data internally
Your firm failed to follow SOP HO-CQA-SOP-072, Enumeration of Microbial Colonies. On February 19 2024, while reviewing the personnel monitoring
Your firm failed to follow SOP HO-CQA-SOP-072, Enumeration of Microbial Colonies. On February 19 2024, while reviewing the personnel monitoring
Your firm failed to follow EP4-PR-SOP-042, “Guidelines for Working in Aseptic Area” and EP4-MB-SOP-028, “Viable Monitoring Program”. The following are