Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What degree of validation should be necessary when data is recorded on a computer and a second system? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 6.5 says, “. . . should include complete information relating to production”, yet clarification to 6.3 says “. . . short document for recording results”; please explain the discrepancy. 1.37K 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? 1.41K 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? 1.76K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations for second-person review of data entry in the laboratory including weighing, adding, etc.? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between official and established specifications? Are these terms interchangeable?. 1.56K 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? 1.75K 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? 1.51K 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? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Should raw materials have traceability so as to establish the raw material history, etc.? 1.61K 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? 1.71K 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? 1.60K 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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to calibrate non-critical equipment? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it the expectation of Q7A that equipment should be calibrated before and after a preventive maintenance is done on a piece of equipment? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What types of controls are expected if the calibration of equipment is contracted to outside agencies? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A consider 21 CFR Part 11, and what is the regulatory status for compliance when inspecting an API manufacturer? Does Q7A specifically address or imply compliance requirements? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Master batch instructions written by a word processor using something like Microsoft Word, then printed, reviewed and approved as a hard copy, which is signed and dated. True or false, is this an electronic record? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 4.2 requires utility system drawings be available. What level of documentation/drawings is expected? Are piping and instrumentation diagrams sufficient, or are drawings showing actual dimensions expected? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans The CGMP regulations for drug products, 21 CFR 211, specify a written record of major equipment cleaning, maintenance, and use shall be included in the individual equipment logs. Q7A does not specify individual equipment logs, only records. Does this mean individual equipment logs are no longer necessary/ expected for API manufacturing? 1.54K viewsDrugsPharmaceutical « Previous 1 2 … 5 6 7 8 9 … 82 83 Next » Question and answer is powered by anspress.net
