my question is simple.
if i manufacture injectable product ivermectin in oral liquid area in bulk and transfer it to sterile filling area and do the filling in aseptic condtions is it correct ?
could you please highlight your opinion . management tells me forget about GMP etc etc
There is a lot of difference in having controls for manufacturing sterile and non-sterile pharmaceutical products. The controls are more stringent for injectable products manufacturing, such as
- Control of microbial load and endotoxin levels in the raw materials to be used for injectables
- Use of WFI for compounding/production of liquid injection products
- Air handling system of cleanliness class is different (HVAC System)
- Equipment cleaning procedures are more stringent with respect to the use of WFI for the final rinse
-Equipment surface monitoring for bioburden and endotoxin levels
-Close monitoring of non-contact surfaces introduction areas - Manufacturing setup is totally different with respect to entry/exit procedures, cleanliness class, environmental controls, handling / transferring/dispensing of raw materials, in-process materials etc.
Therefore considering the above stringent requirements to manufacture sterile injectable products we can not transfer the oral-liquid bulk product into the sterile area for filling without prior controls and measures.
- How can you forget GMP requirements to manufacture pharmaceutical products, whether it is non-sterile or sterile products?? Please convey to your management about cGMP requirements which are mandatory and must be followed. And not according to our wish or desire.
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