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. 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 11, what do you test for labeling? 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? 1.05K 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? 1.19K 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. 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the FDA have any objection to storage and shipment of APIs in polyethylene lined fiber drums? 1.18K 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? 1.13K 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. 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding packaging materials. To what standards should they be cleaned? 839 viewsDrugsPharmaceutical 0 Votes 1 Ans Is Section 9.3 on label issuance and control, applicable for intermediates? 964 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? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify reused containers cleaned according to documented procedure. Does this include secondary containers? 1.20K 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? 817 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? 1.01K 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. 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Why do you have to take all markings off a container that you might reuse? 1.07K viewsDrugsPharmaceutical « Previous 1 2 … 47 48 49 50 51 … 79 80 Next » Question and answer is powered by anspress.net
