Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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 0 Votes 1 Ans Section 2.8 of OECD Advisory Document Number 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) indicates that where the peer reviewing pathologist’s findings were significantly different from the original interpretation of the study pathologist, a description of how differences of interpretation were handled and changes made to the study pathologist’s original interpretation should be discussed in the final report. Does this apply to both retrospective and contemporaneous peer review? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 2.5 of OECD Advisory Document Number 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) indicates that all correspondence regarding the histopathological evaluation of the slides used for peer review between the sponsor and the representative of the test facility and the peer reviewing pathologist should be retained in the study file. Could the interpretation of this requirement be clarified? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Do software programmes which have been developed by outside vendors or academia to support calculations by test facilities using an OECD Test Guideline, and are referenced in OECD Test Guidelines, need to be validated by test facilities? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Can GLP studies be done in facilities that utilise other quality standards (GMP, GCP, ISO etc.)? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a standard format and content for the Study Director’s statement? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a physical/chemical test system? 1.61K viewsDrugsPharmaceutical « Previous 1 2 … 68 69 70 71 72 … 79 80 Next » Question and answer is powered by anspress.net
