Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Who is considered to be the original manufacturer of the API for purposes of the Certificate of Analysis (CoA)? 1.75K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to replace the original label, which contains the information of the original manufacturer? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Could a distributor of an API engage a contract manufacturer for production Steps? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What does ICH Q7 mean by ‘Agents, brokers, traders, distributors, repackers, or relabellers’? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘where subcontracting is allowed’ [ICH Q7, Section 16.14]? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Which outsourced activities are covered by ICH Q7? 1.81K viewsDrugsPharmaceutical 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]? 1.54K 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’? 1.52K 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? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the responsibilities of a TF include IT facilities/services and archive/e-archive facilities? 1.67K 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)? 1.61K 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? 1.50K 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? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the most common challenges with cleaning and cleaning validation? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you have any suggestions for a facility to maintain an “inspection-ready” state? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is cleaning and cleaning validation so crucial to the pharmaceutical industry? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Which significance do the PIC/S Guidances have? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Traceability matrix – what is necessary? Must an end user have a traceability matrix, administrate it and validate it? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans What is standard software? Does standard software have to be validated? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to approve hardware and software suppliers formally? 1.66K viewsDrugsPharmaceutical « Previous 1 2 … 67 68 69 70 71 … 82 83 Next » Question and answer is powered by anspress.net
