Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Must the intermediate and API storage containers be identified in the batch production records? Must critical materials be identified in the batch production record? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Corrections have to be signed and dated. How about the original entry? Seems logical that both be dated. 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Q7A definition for deviations? For example, if one forgets to sign and date a step, but the same person goes back at a later time and signs and dates the step, does a deviation need to be written? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Does 9.4 label information apply to API samples submitted for laboratory testing? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to delegate the batch record review of non-critical process steps to production, reviewing completed batch records and lab records of critical process steps before the release of the API? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Should the time of execution of each step in the batch record be recorded? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Is black ink pen, which looks like photocopying, acceptable for filling in data in batch records? 1.58K 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. 1.55K 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? 1.54K 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.? 1.61K 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? 1.37K 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? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations for second-person review of data entry in the laboratory including weighing, adding, etc.? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between official and established specifications? Are these terms interchangeable? 1.70K 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? 1.43K 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? 1.30K 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? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Should raw materials have traceability so as to establish the raw material history, etc.? 1.43K 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? 1.69K viewsDrugsPharmaceutical « Previous 1 2 … 71 72 73 74 75 … 82 83 Next » Question and answer is powered by anspress.net
