Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How should the frequency of QA audits be determined? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Why are there still inconsistencies in the way different national GLP compliance monitoring programmes inspect multi-site studies? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Are Biologicals/GMOs test items or test systems? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Should new OECD Test Guidelines be developed for Biologicals/GMOs? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Which Test Facility “area of expertise” should be used for Biologicals/GMOs? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Would such global archives need to be declared by each test facility to their national GLP compliance monitoring authority? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans If a GLP inspector requests information retained in an archive, can a test facility respond by retrieving electronic records from a company’s global electronic archiving system (physically located in another country)? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans For some national GLP compliance monitoring programmes, it is acceptable to archive electronic data in a primary database with the use of appropriate access rights (i.e. read only permission for the study director / the study staff/QA and full rights for the archivist etc.). For other national programmes, data can be physically transferred to another location or to a storage medium (also with the corresponding access right modifications) for archiving. Are both acceptable? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans How should hosted services (“cloud” computing) and the retention of electronic data be treated in the context of GLP. 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the responsibilities of TF management with respect to support records? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to harmonise retention times for archived records? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Should an IT service provider that offers software as a service be considered a TF and therefore be included in a national GLP compliance monitoring programme? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the responsibilities of a TF when third parties subcontract non-GLP hosting services with data acquisition systems used in GLP studies (e.g. data storage such as “e-archiving as a service”)? What is considered acceptable? If a data centre uses an IT service provider to only provide infrastructure for the data centre (e.g. space, power, controlled environmental conditions, etc.) or hosting servers of a contracted GLP test facility (i.e. access to the GLP data is only possible via the Test Facility), is this data centre considered to be part of the TF (and not a third party)? Would such a data centre need to be part of the test facility audits? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an audit of QA activities required? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Who should sign the QA statement? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans What should appear on a quality assurance statement? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans What standard should be applied to the validation of methods which are used in GLP studies and how should it be applied? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Should method validation be completed prior to the initiation of a GLP study? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Following the early termination of a GLP study is there a requirement to produce a final report? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Under what circumstances can a GLP study be reopened after the final report has been finalised? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 68 69 70 71 72 … 82 83 Next » Question and answer is powered by anspress.net
