Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Does a software supplier have to be audited at all events, or would it be sufficient if the supplier filled in a questionnaire which would then be assessed by the QA unit? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans In which intervals do systems have to be validated? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Are the terms ‘deviation’ and ‘non conformance’ synonyms? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it permitted to use the same equipment to manufacture materials to be used in pre-clinical and clinical trials? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Do [ICH Q7, Sections 18.14, 18.2] apply to classical fermentation and biotechnology? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Does ICH Q7 expect validation for viral removal/viral inactivation steps for biological/biotechnological products? 1.75K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is considered to be the original manufacturer of the API for purposes of the Certificate of Analysis (CoA)? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to replace the original label, which contains the information of the original manufacturer? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Could a distributor of an API engage a contract manufacturer for production Steps? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What does ICH Q7 mean by ‘Agents, brokers, traders, distributors, repackers, or relabellers’? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘where subcontracting is allowed’ [ICH Q7, Section 16.14]? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Which outsourced activities are covered by ICH Q7? 1.89K 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]? 1.57K 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? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the responsibilities of a TF include IT facilities/services and archive/e-archive facilities? 1.71K 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)? 1.65K 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 Current requirements on the validation of computerised systems seen against the background of the new PIC/S Guidance “Good Practices for Computerised Systems in Regulated ‘GXP’ Environments” 1.74K viewsFDA 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 « Previous 1 2 … 248 249 250 251 252 … 283 284 Next » Question and answer is powered by anspress.net
