Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.16K 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? 1.19K 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? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to blend second crop material with first crop material? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans I’ve got a question regarding the labeling that I discussed for materials that are subdivided in Section 8.1. For any material with hazardous specification, is Q7A in line with OSHA or other safety requirements for labeling or how does Q7A deal with the safety? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans If a validated automated warehouse is used for inventory control of materials and/or product, does this type of system provide adequate control or access to labeling material or are additional controls for separate storage areas required for printed materials? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans For packaging and labeling issues, is material transferred to and from contract manufacturers still considered control of the API parent firm? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you elaborate on your last slide in packaging stating if a container seal breach occurs or a label is missing recipient will be alerted to the possibility of contents being altered? The first question is who should do the alerting? A missing label can occur in transport and originator may not even know it. 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is that in the GMPs? 1.13K 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”. 931 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. 1.15K 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? 1.20K 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? 1.19K 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? 843 viewsDrugsPharmaceutical 0 Votes 1 Ans Is Section 9.3 on label issuance and control, applicable for intermediates? 966 viewsDrugsPharmaceutical « Previous 1 2 … 228 229 230 231 232 … 283 284 Next » Question and answer is powered by anspress.net
