Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 11, what do you test for labeling? 1.71K 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. 1.65K 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.” 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What are FDA’s concerns about the use of raw manure as fertilizer in crop production? 1.33K viewsFDA 0 Votes 1 Ans What research has FDA already done into the survival of pathogens, such as E. coli O157:H7, in soil amended with raw manure? 1.72K viewsFDA 0 Votes 1 Ans Is it acceptable to blend second crop material with first crop material? 1.70K 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? 1.69K 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? 1.42K 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? 1.76K 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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it only required for critical steps to be witnessed or should all steps be witnessed? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to perform homogeneity tests on two acceptable batches that have been blended into one batch? 1.64K 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. 1.53K 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? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans The section on impurities relates only to process-related impurities. Does Q7A address impurities that arise from contaminants external to the process, for example, brine inclusion into a batch from a condenser failure? If not, where is this addressed? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the agency expect a maximum residual carry over from a previous batch to be specified and validated? What other rationale could be used for demonstrating that residual carryover does not affect final API quality? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans “All agree for closed system environmental monitoring room classifications are not necessary. What about where a finished API is isolated and packaged? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans On production and process controls, if carry over from batch to batch is allowed, how would you address an issue of raw material related recall? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to blend some different OOS batches to have a sufficient quantity of products to perform reworking or reprocessing? 1.53K viewsDrugsPharmaceutical « Previous 1 2 … 47 48 49 50 51 … 283 284 Next » Question and answer is powered by anspress.net
