In which conditions we raise the change control and which type of supporting data required?for this any suggestive guide lines available,please mention.
Thanking you
vasu
[quote=srinivas2202]In which conditions we raise the change control and which type of supporting data required?for this any suggestive guide lines available,please mention.
Thanking you
vasu[/quote]
A change control is raised incase of modifications and corrective actions in a consistant process. Written change control procedures are necessary to prevent inappropriate changes in the process. These procedures ensure consistency in the products manufactured and allow for appropriate review and approval of any and all possible changes.
Change control procedure is to control the changes. The chance is properlly reviewed, identify why this changes is required.
The changes is properlly documented and if requried change the SOP, requalifiction of area & equipemtn done as per changes.
One thing not explicitly mentioned in the previous posts is that you would need to apply change control only after the item has been baselined.
For example, if you’re developing software (not released, still in R&D) and the programmer needs to change something, that change can be made without change control. After the software has been baselined (generally as soon as it goes into formal test), then you want to start tracking changes.
[quote=yodon]One thing not explicitly mentioned in the previous posts is that you would need to apply change control only after the item has been baselined.
For example, if you’re developing software (not released, still in R&D) and the programmer needs to change something, that change can be made without change control. After the software has been baselined (generally as soon as it goes into formal test), then you want to start tracking changes.[/quote]
I would say that:
A change control is raised by the person identifying the change to be implemented or already implemented (trying though to establish the change control prior to the implementation of the change). A change control is raised when the change could have an impact to the quality of the product to be delivered to customers. Such a change could be organizational changes of key personnel, installation of a new equipment, change in the manufacturing process etc.
Now, when you fill in the change control and document the change to be imlpemented (identify also whether this is a planned or unplanned change) you should set the prerequisit actions that should be done. Only if these actions are implemented you can then consider the change closed.
For instance: Purchase of new tank and replacement of the old one / Reason for the change: Larger Volume required
Actions:
- IQ/OQ/PQ
- PV of the products whose production is involved in this tank (plus any stability issues)
- Issue new SOPs for the operation of the new tank and the cleaning process of the new tank
- Update CV to include the new tank
- Update VMP
- Place the gauges of the tank into the calibration schedule
- Place the tank into the maintenance schedule
- Review current Manufacturing Instructions of the products involved in the new tank to describe the use of the new equipment.
etc…
Hope this helps.
Best regards,
Nice post Gigastorm
[quote=srinivas2202]In which conditions we raise the change control and which type of supporting data required?for this any suggestive guide lines available,please mention.
Thanking you
vasu[/quote]
Change control is raised to modify or corrected the old one system in which changes are compulsory and no effect on product quality. In that case you require old data and the proposed change data of the same.
Nice discussion,
Can anybody guide me, Does a change control require for the like to like changes.
e.g. If I replace the malfunctioning sensor with another sensor in the steriliser (Having same make, capacity but different serial number).
Shall I need to do raise the chnage control.
Anil Chaudhari
[quote=Validation_Guru]Nice discussion,
Can anybody guide me, Does a change control require for the like to like changes.
e.g. If I replace the malfunctioning sensor with another sensor in the steriliser (Having same make, capacity but different serial number).
Shall I need to do raise the chnage control.
Anil Chaudhari[/quote]
Here first you need to check whether the change has an impact on product quality/process or not. if yes, you need to raise the change control, justify the change and define the actions for the implementation of change.
No need to take change control for like to like changes, but the change data should be recorded and updated somewhere like…Equipment history card,MCP etc…
regards…
Dasarath
Nice discussion!!
Is it required to raise change control for change in the art work of the Secondary packing materials like Cartons etc as it is not impacting the quality of the product?
Thanks,
MUKESH VARDE
Hi,
Any type of changes, which may be a part of the process or product. Whether its major or Minor. It should be routed through change control only. Even it is like to like change machine parts also.
One thing i woluld like to add in this that while filling any change control three things must be specified first the current situation ,second reson for change and third justification for the change proposed.
Regards
Arun
[quote=mukesh.dv]Nice discussion!!
Is it required to raise change control for change in the art work of the Secondary packing materials like Cartons etc as it is not impacting the quality of the product?
Thanks,
MUKESH VARDE[/quote]
I would say yes, as the carton artwork will be registered as part of the product license. Remember, the product license does not only apply to the ingredients, manufacture, final product and primary packaging, but to the outer packaging as well.
OK any artwork changes will not have direct impact the product quality, but changes could have impact on legibility of text (e.g. for visually impared “users”). The regulatory body with whom the product is registered, would not be impressed if you changed the artwork without the proper document trail. Change control must apply to all GMP aspects of product manufacture.
hi,
For like to like part like sensor changes in machines, can be recorded in the equipment history card.
It depends upon the criticality of the machine part. For example if there is change in RMG impeller like to like part, should be routed through change request.
It is depends up on case to case basis and the criticality of the change.QA should assess the situation and take the decision. This can be also defined in the SOP
veera
A change control is raised after 3 sucessful temperory change control which will improve & not compramise the quality , purity & strength, shall be supported with all relevant data .
Dear Srinivas,
In my opinion, Change control is filled when any change is made to the system or process or procedures and that change must be identified and justified. Need to mention reason for change made and its impact assessement. These changes also need to be approved.
You can follow US FDA BACPAC [Bulk actives post approval changes ] guidelines for control of changes.
For your ready reference guideline attached below.
[attach]384[/attach]
[attach]385[/attach]
Thanks and regards
Guidence - BACPAC.pdf (66.4 KB)
BACPAC Q&A.pdf (35.4 KB)