Case 1…Manufacturing of product A in tank 1 and simultaneous activity of CIP or SIP in tank 2.(Manufacturing area)
Case 2.Filling of product A from Tank 3 and CIP/SIP in Tank 4.(Filtration area)
Tank 3 is connected to filling machine with fixed pipping to buffer vessel and filling is in progress.
Tank 4 CIP and SIP can be done simultaneously when FV1 is engaged in filling process.
Here all the Tanks and Pipping are completely in closed system with isolation valves with interlocking and feedback mechanism to avoid Mix up and cross contamination
Utilities are available.
Tanks are Fixed and connected to online tankless CIP/SIP systems.
Please suggest Two activity at a same time in same area is allowed as per GMP?
After completion one activity, second activity should be start, if any incidence happen it will be not easy to identify the root cause , and at a time two different activity not allowed in same area
Sir what is the industrial practice in regulated companies.
Most of the companies do follow CIP/SIP of one tank when batch is going on in another in the same area can’t it be justified by Risk assesment,Mitigation statergy,Isolation valves and interlocking and Design as per QBD.
What is regulatory Requirement? as per my knowledge all the guidelines tells there should not be MIx up and Cross contamination/Contamination.
According to cGMP only one product should be present in one area because more than one product leads to the chances of cross contamination whether you have completely sealed your product…