During aseptic filling operations, procedure EP2-PRD-SOP-002, “Personnel Behaviour in Aseptic Area” and line specific intervention procedures were not followed
Your QC Microbiology laboratory has no equipment usage logbook or any other document that records incubator usage details for a
Specifically, your quality unit did not follow its own procedure, POL-QA-1005 Quality Unit Policy which defines the responsibilities of all
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
On 25 August 2023, observed for plant *** RABS Fill Line *** Batch #*** was the transition of the ***
Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:
On July 11, 2023, two (2) of
Specifically, your firm failed to establish and/or follow adequate written gowning procedures pertaining to the core manufacturing areas to ensure
Microbiologists responsible for collecting environmental monitoring and personnel monitoring samples confirmed they do not collect all samples due to workload.
Specifically, during setup, aseptic filling, transfer of equipment and components, and line disassembly/cleaning in the Grade A area of ***