Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Will the outbreak lead to reconsideration of or changes in current policy/regulations? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Can electronic copies be used as accurate reproductions of paper or electronic records? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to retain paper printouts or static records instead of original electronic records from stand-alone computerized laboratory instruments, such as an FT-IR instrument? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Can electronic signatures be used instead of handwritten signatures for master production and control records? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans When does electronic data become a CGMP record? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Why has the FDA cited use of actual samples during “system suitability” or test, prep, or equilibration runs in warning letters? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to only save the final results from reprocessed laboratory chromatography? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an internal tip regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Should personnel be trained in detecting data integrity issues as part of a routine CGMP training program? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the FDA investigator allowed to look at my electronic records? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA recommend data integrity problems identified during inspections, in warning letters, or in other regulatory actions be addressed? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Processes of Complying with Pharmaceutical Compliance? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Significant Aspects of Pharmaceutical Compliance? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Many of our production processes are documented by means of a batch record on paper. What should we do as concerns the review of the audit trail? Should we review the good documentation practice in the batch record by means of an audit trail review? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans A small filtration facility (pressure measurement/flow measurement/temperature) with a locally installed SCADA system would then rather deliver static data? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an “audit trail”? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA use the terms “static” and “dynamic” as they relate to record formats? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA use the term “backup” in § 211.68(b)? 2.14K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the “systems” in “computer or related systems” in § 211.68? 2.20K viewsDrugsPharmaceutical 0 Votes 1 Ans When is it permissible to exclude CGMP data from decision making? 1.58K viewsDrugsPharmaceutical « Previous 1 2 … 29 30 31 32 33 … 82 83 Next » Question and answer is powered by anspress.net
