Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is the difference between retest date and expiration date for drug substances? 1.22K viewsDrugs 0 Votes 1 Ans How capa helps pharmaceutical industry, regards sunil wakhloo? 1.03K viewsDrugs 0 Votes 1 Ans Under what conditions can quality typically delegate authority for releasing Intermediates to production? 1.29K 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? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the FDA have any objection to storage and shipment of APIs in polyethylene lined fiber drums? 796 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. 993 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? 1.03K 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.” 1.24K 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? 1.23K 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? 971 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? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 8.4 says that batches should have been tested prior to blending. Do you strongly recommend doing it prior to or is it possible for the company to take a business risk and test individual batches at the same time that blending operation is taking place? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it only required for critical steps to be witnessed or should all steps be witnessed? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to perform homogeneity tests on two acceptable batches that have been blended into one batch? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Is mixing of two or more batches of intermediate allowed, one of which might be OOS, into solution when reacting the next stage? Assume a weighted average meets the specification. 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans This one applies to chromatography fractions and if your specification is 90 to 100% for the potency, is mixing of fractions with a potency less than 90% allowed if the final potency of the blended fraction meets the not less than 90% purity requirement? 1.33K viewsDrugsPharmaceutical 1 2 3 … 79 80 Next » Question and answer is powered by anspress.net
