Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Could you provide some additional comment regarding the filing requirements for alternative rework processes, and if prior approval is required for recovery procedures? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Do all record keeping and traceability requirements apply for brokers to chemicals and intermediates before the API starting material? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Slide 6.26 requires the investigation of deviations and results of release testing after the completion of each significant step. Usually release testing and deviation investigations take longer than it takes to complete each significant step. Is it acceptable to include this documentation in a report after completion of the batch instead of after each significant step? 1.71K 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? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans In which document does one designate the API starting material, the drug master file or some other filing application? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to complete any investigations including out-of-specification investigations (OOS), prior to release of product? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans As a repackager of APIs, we use an expiry date only when one is given by the manufacturer. However, in a recent inspection, the investigator insisted that all APIs should have an expiry date. We believe this to be incorrect and would like to know what argument we should use to defend the fact that most APIs do not have an expiry date. 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected to have a complete graph or printout of the whole process batch attached to the batch record for a critical or significant step? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Since results for critical process parameters must be recorded, must the API manufacturer identify critical process steps and parameters in the batch production record? 1.57K viewsDrugsPharmaceutical 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? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Corrections have to be signed and dated. How about the original entry? Seems logical that both be dated. 1.62K 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? 1.55K 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? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Should the time of execution of each step in the batch record be recorded? 1.63K viewsDrugsPharmaceutical 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 « Previous 1 2 … 4 5 6 7 8 … 79 80 Next » Question and answer is powered by anspress.net
