D
Dr.mohamedezeldin
hi , i am new in this forum and i am looking to a true accident that show it cause and the corrective action , and the protective action.
and finally thank you.
and finally thank you.
A true example of CAPA - Accident that show its cause and the corrective action
CarolX
Trusted Information Resource
hi , i am new in this forum and i am looking to a true accident that show it cause and the corrective action , and the protective action.
and finally thank you.
Hi Dr.mohamedezeldin and Welcome to the Cove!
I am not sure what you are looking for - are you looking for any example of a CAPA for defective product, or something else? You refer to an "accident" - could you clarify a little more.
hi , i am new in this forum and i am looking to a true accident that show it cause and the corrective action , and the protective action.
and finally thank you.
Welcome to the cove
Do you mean a "nonconformance" when you refer as accident ? If you are looking for examples of CA and PA (Preventive Action) and not Protective action, we have lot of examples in the forum. Use the SEARCH to get information.
D
Dr.mohamedezeldin
Thanks for your replies,
what i mean is a nonconformance specialy in pharmaceutical industries.
what i mean is a nonconformance specialy in pharmaceutical industries.
J
Jimmy the Brit
Pharmaceutical nonconformances don't come much bigger than this:
Five people died as a result - a salutory lesson to those who think that drugs are "overcontrolled".
Regards,
Jimmy
S
Sandra Gauvin
Here's a few real world examples....
Example 1: A Quality Assurance person responsible for reviewing and approving Change Controls let his yearly GMP refresher training lapse while continuing to review and approve Change Controls.
Example 2: An operator documented incorrect information (i.e. wrong date) on a controlled record and did not use good documentation practices when they fixed the error.
Example 3: A nonconformance investigation was not completed within the specified amount of time prescribed in the SOP and did not have any approved extension justifications.
Example 4: Procedure required a 'Performer' and a 'Verifier' to complete and document task....only the Performer signed off on the documentation.
Example 1: A Quality Assurance person responsible for reviewing and approving Change Controls let his yearly GMP refresher training lapse while continuing to review and approve Change Controls.
Example 2: An operator documented incorrect information (i.e. wrong date) on a controlled record and did not use good documentation practices when they fixed the error.
Example 3: A nonconformance investigation was not completed within the specified amount of time prescribed in the SOP and did not have any approved extension justifications.
Example 4: Procedure required a 'Performer' and a 'Verifier' to complete and document task....only the Performer signed off on the documentation.
A
achorste
What about Centerpulse's major problems that ultimately led to the company being sold off to Zimmer?
If I remember correctly (this is second hand info - someone else may be able to clarify), they changed their machining / cleaning processes without going through the normal change control / testing requirements that mean the cups did not fixate properly (pain for the patient & another operation to replace).
If I remember correctly (this is second hand info - someone else may be able to clarify), they changed their machining / cleaning processes without going through the normal change control / testing requirements that mean the cups did not fixate properly (pain for the patient & another operation to replace).
S
Sandra Gauvin
You can also take a look at FDA warning letters to pharmaceutical companies at the link below.
http://www.accessdata.fda.gov/scripts/wlcfm/searchwl.cfm
http://www.accessdata.fda.gov/scripts/wlcfm/searchwl.cfm
