I do have almost all of the equipments that are not qualified and needs to be qualified. I am thinking about doing the retrospective qualification comprising all the issues of 4Qs in a single document.
I am taking the issues of maintenance, calibration of the equipment and performance testing of the equipments for qualifying the equipments.
Could somebody reply me how to conduct the risk analysis for conducting the retrospective qualification? Does the risk analysis adresses the issues of the performances of the machines or it could other issues like the deviations, change controls, calibration and other activities or issues that is required for qualifying the equipments.
Sorry for my English.
Prawan Dahal
Hi,
You need to use a risk assessment SOP that will help you decide what level of validation is required to ensure these equipment types are compliant.
Your risk assessment should tell you what category of GAMP your equipments fall into and then when that assessment is made the level of validation should be detailed.
Deviations and Change Controls should already be part of your Quality System, and should be included in your overall Validation Project Plan.
Calibration and the Calibration Interval should be included as part of an IQ test. This would in my view should be a prerequite check before any qualification/validation is performed.
Hope this helps
Thanks gokeeffee for your reply,
I am facing a problem now. What happened I was trying to qualify retrospectively Rapid Mixer Granulator used for mixing and granulation. I was able to qualify the mixing of the equipment taking the historical data of critical products on the basis of the assay of the product.
I am thinking to qualify the granulation of the machine by taking the datas of granulation time, amount of fluid added for granulation and the ampere reading. But I could not guarantee the performance of the ammeter reading. We are also not using the data of ammeter reading to select as end point of granulation. We are dependent on the visual inspection of the granule formation. We are not facing problems after granulation, drying and compression too. This indirectly indicates that the granulator is OK. But I do not know now how to qualify the granulator retrospectively? Have you some methods to qualify the machine retrospectively in term of its granulation action?
Suggestions are highly appreciated,
Prawan Dahal
[quote=gokeeffe]Hi,
You need to use a risk assessment SOP that will help you decide what level of validation is required to ensure these equipment types are compliant.
Your risk assessment should tell you what category of GAMP your equipments fall into and then when that assessment is made the level of validation should be detailed.
Deviations and Change Controls should already be part of your Quality System, and should be included in your overall Validation Project Plan.
Calibration and the Calibration Interval should be included as part of an IQ test. This would in my view should be a prerequite check before any qualification/validation is performed.
Hope this helps[/quote]
I got the answer. I can qualify the mixing activity of the equipment retrospectively. But since due to the missing of some historical data and also unreliability of the ammeter reading (as it was not calibrated regularly) the granulation activity should be qualified in terms of prospective cycle i.e. by analyzing the concomitant ongoing data for the selected worst case products.
Any other ideas are highly appreciated.
Prawan Dahal
No.
It is my organizations responsibility to keep over 900 chapters and over 200K members in check. They are doing what they need to do to account for every contingency that they can account for beforehand.
Dear
since u r doing retrospective Qualification based on the historical background, in my opinion there is no requirment to carry out risk analyis coz risk appproch to be done on new equipment or system prior to start IQ.
in retrospective qualifiaction equipment/system is already exposed to enviroment or prodcut and running succfully. hence no requirment for risk analyis.
Retrospective qualification done with the help of history card of equipment.
number of batches produced through this equipment.
Regards
prasad Aparajit
Q.A.
Torrent Pharmaceuticals
ahemdabad
QUOTE=daprawan;2278]I do have almost all of the equipments that are not qualified and needs to be qualified. I am thinking about doing the retrospective qualification comprising all the issues of 4Qs in a single document.
I am taking the issues of maintenance, calibration of the equipment and performance testing of the equipments for qualifying the equipments.
Could somebody reply me how to conduct the risk analysis for conducting the retrospective qualification? Does the risk analysis adresses the issues of the performances of the machines or it could other issues like the deviations, change controls, calibration and other activities or issues that is required for qualifying the equipments.
Sorry for my English.
Prawan Dahal[/quote]