Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does ICH Q7 preclude a contract manufacturer’s independent quality unit from performing the main responsibilities as described in [ICH Q7, Section 2.22]? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Must a quality related return, at the request of the API manufacturing site, from another site within the same company be recorded as a ‘recall’? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the roles and responsibilities of a TF and IT provider when GLP data are retained by an IT provider that is not part of a GLP monitoring program? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the responsibilities of a TF include IT facilities/services and archive/e-archive facilities? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Some TF activities may be performed by external suppliers (e.g. IT services, eArchive, metrology, computer system validation). What are the responsibilities of TFs with regard to these types of suppliers when these suppliers are not GLP certified (i.e. the suppliers are not included in a national GLP compliance monitoring programme)? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the responsibilities of Test Facilities (TF) and sponsors with respect to overseeing the work and ensuring the qualifications of the full range of GLP service providers / subcontractors? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans As an instructor of the ISPE Cleaning Validation Principles training, what do you believe are the key takeaways of this course? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the most common challenges with cleaning and cleaning validation? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you have any suggestions for a facility to maintain an “inspection-ready” state? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is cleaning and cleaning validation so crucial to the pharmaceutical industry? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Which significance do the PIC/S Guidances have? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Traceability matrix – what is necessary? Must an end user have a traceability matrix, administrate it and validate it? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans What is standard software? Does standard software have to be validated? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to approve hardware and software suppliers formally? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans How should the frequency of QA audits be determined? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Why are there still inconsistencies in the way different national GLP compliance monitoring programmes inspect multi-site studies? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Are Biologicals/GMOs test items or test systems? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Should new OECD Test Guidelines be developed for Biologicals/GMOs? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Which Test Facility “area of expertise” should be used for Biologicals/GMOs? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Would such global archives need to be declared by each test facility to their national GLP compliance monitoring authority? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 67 68 69 70 71 … 79 80 Next » Question and answer is powered by anspress.net
