Hi, rather than reading the GMP guidelines, please explain it with practical examples. Like how to implement manual process for legacy system?? What does it exactly expected and how...
Hi, you further go through our recorded webinars on different topics which are related to data integrity. Please go through the link for series of recorded webinars. Request you to go through it in details and understand it. If you have further questions, I will revert you. ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-pBnsXTe5jpw.html
i working in WHOGMP plant but hear audit trial not review before batch release....there is monthly shedule review audit trial on instruments HPLC /GC by QA person its right?
hello, i am use empower3 , from technically view what is the critical points should be review in audit trail of HPLC (Intrument method , sample set , processing method , results), and what is the standard during audit trail review ?, and if i want to write this in SOp , what is the main points should be wriiten in the sop for auidt trial review? and is there a audit trail checklist which facilitate review?
Hi, I suggest, you need first perform risk assessment. This is first stage of going for practical implementation and complying the PIC/S or EU guide - "Consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated "audit trail"). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed". Once you perform the risk assessment as per above requirement, you will come to know the audit trail checks related to specific injection - That you can take print along with chromatogram print and review as routine practice. While you can review the system audit trail at the end of the day. You can review the method audit trail once, the batch testing is over. But before release. However you should not restrict yourself for only review of computerised system audit trail. Hope this will solve your purpose. For further details, please feel free to put comment further.
@@JC-qu1se Hi, I suggest, you need first perform risk assessment. This is first stage of going for practical implementation and complying the PIC/S or EU guide - "Consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated "audit trail"). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed". Once you perform the risk assessment as per above requirement, you will come to know the audit trail checks related to specific injection - That you can take print along with chromatogram print and review as routine practice. While you can review the system audit trail at the end of the day. You can review the method audit trail once, the batch testing is over. But before release. However you should not restrict yourself for only review of computerised system audit trail. Hope this will solve your purpose. For further details, please feel free to put comment further.
You can do audit trail review without QRM. But problem is which checkpoints you consider and why only the selected check points? So to have rationale, it should be based on risk based approach.
All GMP and data integrity guidelines expects to perform audit trail review. You can refer EUGMP, FDA,WHO,PIC/S. Further if you have any questions, please put your questions. I will be happy to solve your queries.
