Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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. 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 11, what do you test for labeling? 1.38K 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? 1.13K 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? 1.31K 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. 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the FDA have any objection to storage and shipment of APIs in polyethylene lined fiber drums? 1.26K 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? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any requirements for labeling of drums of in process materials? These are temporary labels for moving material from one step to another. 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding packaging materials. To what standards should they be cleaned? 931 viewsDrugsPharmaceutical 0 Votes 1 Ans Is Section 9.3 on label issuance and control, applicable for intermediates? 1.05K viewsDrugsPharmaceutical 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? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify reused containers cleaned according to documented procedure. Does this include secondary containers? 1.29K 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? 898 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? 1.16K 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? 1.17K 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? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Someone stated that the quality unit must inspect packaging materials. Can that be delegated? 1.37K 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? 1.10K 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. 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Why do you have to take all markings off a container that you might reuse? 1.23K viewsDrugsPharmaceutical « Previous 1 2 … 47 48 49 50 51 … 79 80 Next » Question and answer is powered by anspress.net
