Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is it appropriate in a batch record to have large spaces, i.e., pages, for handwritten comments to be entered to document observations, etc., as well as spaces for entering data, i.e., tables. 1.91K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every operation in a critical step automatically become subject to QA record review? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API has an impurity, does the dosage form manufacturer have the responsibility to identify it if the API manufacturer provides a C of A? Which of the two does FDA hold legally responsible? 2.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 1.88K viewsDrugsPharmaceutical 0 Votes 1 Ans Do isolated synthetic intermediates intended for use in the next process step need to be quarantined and released by the quality unit? 1.79K viewsDrugsPharmaceutical 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? 1.88K viewsDrugsPharmaceutical 0 Votes 1 Ans Do all record keeping and traceability requirements apply for brokers to chemicals and intermediates before the API starting material? 1.83K 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? 1.92K 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? 1.95K viewsDrugsPharmaceutical 0 Votes 1 Ans In which document does one designate the API starting material, the drug master file or some other filing application? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to complete any investigations including out-of-specification investigations (OOS), prior to release of product? 1.85K 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. 1.84K 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? 1.81K 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? 1.76K 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? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Corrections have to be signed and dated. How about the original entry? Seems logical that both be dated. 1.80K 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? 1.89K viewsDrugsPharmaceutical 0 Votes 1 Ans Does 9.4 label information apply to API samples submitted for laboratory testing? 1.74K 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? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Should the time of execution of each step in the batch record be recorded? 1.87K viewsDrugsPharmaceutical « Previous 1 2 … 4 5 6 7 8 … 82 83 Next » Question and answer is powered by anspress.net
