Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans When doing microbial counts, is using negative controls that succeed proof enough that testing is not the issue? 1.21K viewsPharmaceutical 0 Votes 1 Ans Do you recommend daily flushing of POU drops that are not routinely used? 1.12K viewsPharmaceutical 0 Votes 1 Ans Is there an ideal or recommended number of POU drops that are included in a distribution loop? 1.29K viewsPharmaceutical 0 Votes 1 Ans How often is sanitization of typically recommended? Weekly, monthly, quarterly? 1.13K viewsPharmaceutical 0 Votes 1 Ans Do you recommend any special strategy for evaluating increasing the interval between routine sanitization for a system that has been operating without issues? 1.20K viewsPharmaceutical 0 Votes 1 Ans Pharmaceutical water System Biofilm-Growth through Penetration – How quickly can 0.2 micron filters suffer from growth through penetration (what is a good replacement interval to start with?) 1.07K viewsPharmaceutical 0 Votes 1 Ans If the WFI distribution system circulates at 85 degrees C , is sanitization required? 1.32K viewsPharmaceutical 0 Votes 1 Ans Under what conditions can quality typically delegate authority for releasing Intermediates to production? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans What’s the minimum amount of information required for the labels on containers of starting materials when they are received prior to API manufacturing? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the FDA have any objection to storage and shipment of APIs in polyethylene lined fiber drums? 808 viewsDrugsPharmaceutical 0 Votes 1 Ans 9.2 states that containers should not be additive beyond the specified limits. This imputes the need to evaluate packaging for interaction with the API. On the other hand, that additive of packaging implied is not a concern so long as the API is not altered beyond its specification. Please clarify how an API manufacturer might justify not evaluation product/packaging interactions. 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans What kind of ID test is acceptable for packaging materials, such as polyethylene bags, lined drums? Is the shipping document of packaged material used in lieu of a C-of-A? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans A packaging/labeling question; transport of API outside the facility, can boxes containing API be sealed with tamper-evident tape, or must the inner bottle or container be sealed? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 11, what do you test for labeling? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans With regard to packaging materials, Q7A does not make a distinction between inner and outer containers. If you have written procedures for the inner containers that actually come into contact with the API, do you also need written procedures for the outer containers, such as fiberboard boxes that do not actually contact the API? An example of the inner container might be glass jar or vial. 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you perform accelerated stability studies on an API to extend the retest date if running room temperature studies concurrently? And, the statement is made, “Drug product firms do this routinely, to place a two-year expiry date on the product.” 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to blend second crop material with first crop material? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Is mixing a centrifuge heel material with the next batch not blending? If we don’t consider that blending, how should that be handled? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Can heels from dryers, and the example that’s given here is 60 kilos, be left inside the equipment between batches of the same campaign? 975 viewsDrugsPharmaceutical 0 Votes 1 Ans If you blend a tailing into another batch and then retest the blended batch, if you have a policy that is based on retest dates given after the testing, then wouldn’t the blended batch get a retest clock in this case? 1.31K viewsDrugsPharmaceutical 1 2 3 … 82 83 Next » Question and answer is powered by anspress.net
