Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans The calibration of equipment influences the correctness of data. Does this mean that the calibration is critical? 991 viewsDrugsPharmaceutical 0 Votes 1 Ans What about a reactor control from production that has neither user management nor a password or an audit trail etc.? Is it allowed to continue using this control? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What about a reactor control from production that has neither user management nor a password or an audit trail etc.? (The control concerned is the control of a reactor which is used for the manufacture of intermediates and APIs but not of final products). Is it allowed to continue using this control or does it have to be withdrawn from use? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the audit trail review prior to the release of each batch a regulatory requirement or is it only recommended so far? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Hybrid systems: No audit trail retrofitting possible. What can be done? 970 viewsDrugsPharmaceutical 0 Votes 1 Ans Role concept: Is a user allowed to carry out a reintegration? (GC-system) 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans It is difficult to carry out the separation between the persons of administrator and user in the CDS. Is it possible that the admin and the user being the same person? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Process validation data are category 3 data – therefore no audit trail review is required. But isn’t it required to carry out a review for the generation of validation measuring data? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is there a need for this initiative? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans How did the FDA go about this reappraisal? 869 viewsDrugsPharmaceutical 0 Votes 1 Ans What does “risk-based” approach mean? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a “risk-based” approach to CGMPs mean that certain manufacturing processes will not be regulated if only minimal risks are involved? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it an essential element to execute a disaster recovery process on a manufacturing kit during qualification, and do you see any risk with respect to software removal? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What about systems with no audit trail or an incomplete audit trail? What’s the work-around for such systems? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there examples of audit trail review that are less cumbersome than what Agilent is building into its software? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you talk about addressing the challenges of peak integrations in auto mode instead of manual? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it ever acceptable to delete data in the eyes of the FDA? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans At some point, there must be an administrator for every system who will have access to modify or delete records, how do you recommend dealing with this potential data integrity problem? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a vendor postal audit enough to satisfy GMP requirements? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans When samples are processed, is an audit trail comment enough or is an approval process also necessary? 1.13K viewsDrugsPharmaceutical « Previous 1 2 … 31 32 33 34 35 … 82 83 Next » Question and answer is powered by anspress.net
