How to Qualify vial filling and bunging machine.what kinds of tests are to be carried out to qualify the vial filling and bunging machine.Is there is any guideline about tempelate of PQ protocol.
You need to initiate as follows:
List out input quality parameter.
List out environment quality requirement
Fill weight - parameter added during process.
List out output quality parameter.
List out possible issues likely to be encounter during process of filling and stoppering.
Prepare protocol based on above information listed.
Decide sampling plan and acceptance criteria.
Give detail of possible issue listed, its impact on product quality parameter, make provision to study impact by monitoring such paraemter during process.
review the protocol, get approved.
Execute the protocol as plan and compile the result.
You will have report, include deviation, obervation, discuss out of trend results.
I believe this will serve your purpose
With regards,
Kanu Panchal
Dear Tahir
U need to cover all 4Qs for the qualification, u can see WHO guide line TRS 937eng, in this regard. anyway for the protocl u need to cover Equipment identification, Major Components’ Specification, Verification and Compliance of SOP, Utilities, Spare parts, Technical Drawings, Lubricants, Safety Precautions, Calibration Review for IQ. Equipment Control Function for OQ and Machine capability study for PQ. then u can execute the protocol in a rite direction to get the machine qualified.
Regards,
Shahid Ali
Addis Pharmaceutical Factory SC, Ethiopia
You need to initiate as follows:
-Standart operating procedure verification for only operating,cleaning and maintenance procedures
-motor operational verification
-radio frequency and electromagnetic interference verification
-Logical security access level verification
-screen verification
-program reporting verification
Audit trail
Loss/resoration of power verification
Stop and abort operation verification
(if there are) door safety verification
Alarm verification
Control panael functionality verification
Machine speed and capacity test
Filling accuracy test
Filling needle adjuztment test
Vials / stoppers transfer and abuse verification