Line Clearance in GMP Packaging Operations
I have a query I would like to put to the forum re Line clearance in
Packaging Operations for different types of terminally sterilised
injectables- pharmaceutical and would like feedback on the GMP aspect
of what I am proposing.
IN our Packaging Operations, for each Packaging order, we perform
line clearance on the whole line and then we begin the next order. We
want to reduce the time it takes to do this by: splitting the line
into 2 distinct and segregated stations such that line clearance can
occur at the beginning of a line (station 1) while finishing the
order at the end of a line. As the order is finished line clearance
is also done at end of line. (station 2)
In reality all you are doing is performing activities in parallel
rather than in sequence and in so doing we would reduce our order
time setup to 10 minutes.
Care would be taken to prevent product and label mixups by 1. Double
verified line clearance at each station. 2. Ensuring product travels
one way only. 3. Gated segregation at each station on the line during
line clearance. 4 Partitions at each station to prevent people from
moving. 5. Documented evidence of above 6. We also intend to perform
a risk assessment of each station and compare the overall to existing
Please feedback with any comments or suggestions particularly if you
think this allowable within the cGMP guidelines/rules.