Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Does the label information, as defined in 9.4, apply to starting materials and components used to manufacture API as well? Particularly the retest date on a label or CA? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify reused containers cleaned according to documented procedure. Does this include secondary containers? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Q7A does not seem to differentiate between intermediate and API labeling. Is there a difference? Can you use generic labels that operators fill out? 819 viewsDrugsPharmaceutical 0 Votes 1 Ans Why did Q7A expert work group allow the option of a retest date being placed on the Certificate of Analysis or the container label? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 9.3 states that an example of a printed label needs to be included in the BPR. Does this requirement apply to hand printed labels? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans You mentioned that name and manufacturer and address must be on the label. Would the name and address and the distributor be acceptable? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Someone stated that the quality unit must inspect packaging materials. Can that be delegated? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans API labeling. For APIs manufactured, pre-validation for clinical products, is it required to include a statement limited for investigational use like what’s required for clinical products? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Labeling requirements in Section 9 seem excessively complicated where one batch of API requires label performed every few months. Can this system be simplified, i.e., fill in the blank labels? So they must be talking about product for clinicals. 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Why do you have to take all markings off a container that you might reuse? 1.07K viewsDrugsPharmaceutical 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? 1.12K 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? 957 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? 900 viewsDrugsPharmaceutical 0 Votes 1 Ans Are formal stability studies required for an Intermediate that you are planning on holding? 1.16K 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? 1.24K viewsDrugsPharmaceutical « Previous 1 2 … 229 230 231 232 233 … 283 284 Next » Question and answer is powered by anspress.net
