Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Do all record keeping and traceability requirements apply for brokers to chemicals and intermediates before the API starting material? 1.63K 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? 1.37K 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? 1.53K 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? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Alternate method for rejected material, is it okay not to have a separate area? 1.68K 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? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between evaluating suppliers of critical material in Section 7.1, and the supplier approval evaluation discussed in Section 7.3? Does Section 7.3 pertain to all materials or just critical materials? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Sampling and testing states that, “No testing necessary for special materials if . . .” Please define special materials in this context. 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Where do gases fall, i.e., nitrogen for the blanket, as a raw material or process aid? Do they require material management control, quarantine, ID testing, etc? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 7.3, third paragraph, “describe other special materials.” These are materials excluded from testing. Does the company define the special materials? If so, on what basis? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an appropriate system to allow a material’s use while still under quarantine? What makes a conditional release appropriate? 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. 1.73K 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? 1.71K 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? 1.59K 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? 1.46K 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 « Previous 1 2 … 70 71 72 73 74 … 79 80 Next » Question and answer is powered by anspress.net
