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Process Validation Stages process qualification report excution


In Process Validation the execution of process qualification begins after the approval of the protocol, Following are some of the points regarding execution and preparation of report during process qualification.

Execution will start of begins after the approval of the protocol.

All points mentioned in the protocol are to be followed.

If the points mentioned in protocol is not followed then proper justification is required.

Follow the commercial manufacturing process and the routine procedures.

Manufacturing activities are to be carried out under normal operating conditions.

Normal operating conditions includes the utility system, personnel, material, environment and the manufacturing procedures.

Report prepared after execution should discuss the cross reference of all aspects of the protocol.

Report should summarize all the data and analyze the data as per specification in protocol.

Report should discussion correction actions if necessary.

Clear conclusion whether the activity is followed as per protocol or not.

Review and sign off the report.