Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans This has to do with inspection of packaging and labeling facilities for APIs. Is this intended to be the same level as for drug product line clearance? Can production personnel carry out this check, and does the requirement apply to API only or also to isolated intermediates? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Final product APIs – if the impurity profile changes as a result of scaling up, but still falls within required specifications, what is the status for this API? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Please explain the difference between specification and action limit. If there are no differences, why are both terms used? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans For an API intended for a parenteral drug product that is lyophilized, is it sufficient to test the API powder for moisture content? Do microbiology/sterility issues need to be addressed? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans For starting materials that have no pharmacopoeia monograph, are test methods required to be formally validated or can methods be justified on the basis of scientific logic? 952 viewsDrugsPharmaceutical 0 Votes 1 Ans Whose responsibility is it to obtain the stability information for a filing, i.e. IND, NDA, ANDA, the API manufacturer or the dosage form manufacturer? Does Q7A take a position on this? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans If material is being shipped, can the retest date be on another document that is shipped with the material instead of the C-of-A or label? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Slide 11-11 indicates that a formal testing program is not needed to establish “use by”dates. Does this mean that the lab does not need to establish limits by a formal program for reference standard solutions or HPLC testing, where the standard solution is not prepared fresh each time? 896 viewsDrugsPharmaceutical 0 Votes 1 Ans Are formal stability studies required for an Intermediate that you are planning on holding? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans If storage conditions are not defined on the label, what is the assumed ambient temperature? What is ambient temperature? How is it defined since it varies by geography and times of the year? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there going to be an attempt to harmonize water monographs in the future? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans What does another unit exactly mean in the distribution procedure? 10.2? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to store equipment cleaning logs and use logs in a single location such as a supervisor’s office rather than in close proximity to the corresponding equipment? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Q7A Section 9.4 makes a “requirement to use tamper evident packaging for shipments outside the company control”. True or false? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the retest date calculated from the manufacturing date or from the release date? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a conflict of retest date definitions among ICH, Q7A and Q1A with respect to immediate use? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Are retains of raw materials used to make APIs necessary or required? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA’s March 1998 draft GMP guidance for API manufacturing defined for antibiotics the use of expiry date. Q7A does not have this recommendation, is this difference existing or not? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans What happens if it is not possible to identify an impurity? A new one or one detected…? What happens if it’s just not possible to identify the impurity? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans (Follow-up from floor) That would depend upon the stability of the material? 947 viewsDrugsPharmaceutical « Previous 1 2 … 48 49 50 51 52 … 79 80 Next » Question and answer is powered by anspress.net
