Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is black ink pen, which looks like photocopying, acceptable for filling in data in batch records? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment cleaning and use records. For multi-use, non-dedicated equipment, is it acceptable to have these records as part of the batch record or is a separately maintained record required. 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans For an existing registered process, is the starting material listed in the drug master file registration the starting material for Q7A? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the section on equipment cleaning and use records (section 6.2) apply to lab equipment in the laboratory. For example, HPLCs, balances, GCs, etc.? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Control data requests that you retain data on the preparation and testing of reference standards. Since many of the reference standards are purchased, how can one accomplish this? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans In deciding if a deviation is critical, would one normally expect to see what requirements are critical versus non-critical pre-defined in the production instructions? If not, what justification would one expect to see? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans If a data entry were missed, not done directly after performing the activity, is noted and corrected subsequently, i.e. the next day, would you expect a deviation report, in addition? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations for second-person review of data entry in the laboratory including weighing, adding, etc.? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between official and established specifications? Are these terms interchangeable? 1.76K viewsDrugsPharmaceutical 0 Votes 1 Ans To what level of detail should the manufacturing master production instructions be written with the assumption that the operator has a Ph.D. or is totally ignorant? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans A batch record should be checked before it is issued to production. Can this check be done by production or must it be done by quality? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Does batch record generation software have to be Part 11 compliant? Can Microsoft products be used to generate these batch records? Do batch record generation programs have to be validated? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Should raw materials have traceability so as to establish the raw material history, etc.? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you expect to see an official document from the API manufacturer describing the starting material and its position in the synthetic pathway? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Cleaning records, maintenance records don’t appear to have to be reviewed or checked anymore by a second person or supervisor. Is this true? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Review of critical process steps. Is the complete review of the batch record for a critical process step, meaning a synthetic step, or is it a review of the critical variables within the critical step? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Will API firms be held accountable to these guidelines even though operations were conducted prior to effective date of Q7A? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans In which document does one designate the API starting material, the drug master file or some other filing application? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to complete any investigations including out of specification investigations (OOS), prior to release of product? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What types of controls are expected if the calibration of equipment is contracted to outside agencies? 1.65K viewsDrugsPharmaceutical « Previous 1 2 … 71 72 73 74 75 … 79 80 Next » Question and answer is powered by anspress.net
