Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans For a non-dedicated tanker, if a Certificate of Cleaning is utilized to ensure no cross contamination, does verification of cleaning need to be performed? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans What type of laboratory controls and testing are typically expected of labels and secondary packaging containers? Is visual inspection sufficient? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to physically separate the rejected material or is labeling sufficient? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need separate areas for materials in quarantine or under test? 1.87K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you validate a method for a toxic or a very dangerous raw material? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to audit a supplier? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans There is no specific definition for critical raw material. Should we combine the definition for raw material and the definition for critical to come up with the criteria? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Why aren’t bulk deliveries of chemicals used in API manufacturing held to the same standards as APIs? There is no validation of clean outs for non-dedicated tankers. 2.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Is statistical sampling a lot for raw materials used for production of APIs sent to Europe? 1.94K viewsDrugsPharmaceutical 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. 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every operation in a critical step automatically become subject to QA record review? 1.90K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Do all record keeping and traceability requirements apply for brokers to chemicals and intermediates before the API starting material? 1.94K 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? 1.63K 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? 2.00K 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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Alternate method for rejected material, is it okay not to have a separate area? 1.97K 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? 1.88K 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? 1.87K viewsDrugsPharmaceutical 0 Votes 1 Ans Sampling and testing states that, “No testing necessary for special materials if . . .” Please define special materials in this context. 1.92K viewsDrugsPharmaceutical « Previous 1 2 … 261 262 263 264 265 … 283 284 Next » Question and answer is powered by anspress.net
