Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Adenoviruses. Are they considered whole cell and thus excluded from Q7A? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Please provide some examples of blood or plasma as a raw material where Q7A applies versus blood derivatives where Q7A does not apply? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API is extracted for a mammalian tissue, does Q7A apply? At what stage? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans A biotech intermediate is chemically modified. This modification is maintained throughout the API and drug product. A biotech intermediate is chemically modified, but this modification is removed prior to the completion of the API. Is either or both of the chemicals used for the modification considered an API starting material? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it anticipated that these products would eventually be covered by this guideline? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Why are human plasma-derived protein products specifically excluded from the Q7 guidelines? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans On the definition of fermentation, can a protein isolated from a microorganism, which occurs in nature, be considered as being derived from a classical fermentation if the protein is well characterized? 932 viewsDrugsPharmaceutical 0 Votes 1 Ans As per the presentation, Q7A isn’t intended to raise the GMP expectations for classical fermentation. It was mentioned that cell culture fermentation was one of the two differences between Q7A and the FDA’s previous draft guidance. Confirm or clarify that the main difference is the moving of the line from isolation/purification back to the introduction of cells into the fermentation. 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding the table indicating application of Q7A to biotech processes (Section 1.3 Scope, page 4), and the arrow indicating increasing GMP, does this indicate a change in CBER’s attitude toward GMP levels from early process steps to late process steps, or is the attitude still in place that GMP levels should be consistent through the entire process? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans If there is a biologics regulation that is more comprehensive and more specific than Q7A, why was Section 18 included in Q7A in the first place? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you think Q7A will affect current guidelines on biologics and biopharmaceuticals when current regulations are already ten times more stringent than anybody else’s? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans It was stated that Section 18 should not be used as a stand-a-lone, what parts of other sections don’t apply? For example, process validation for drugs has different completion data than biologics. 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there specific CBER expectations for classification of rooms in which biotech fermentations take place? For example, 10,000 and 100,000. 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans How is the API source material for fermentation process defined? Can you provide an example as was provided for the chemical process? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans For classical fermentations that have been around for 30 plus years the practice has been to validate the sterilization of the fermentation vessel and the feeds. Do you think this is adequate? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you think that shared or divided manufacturing will be possible in biotech? Would this require the ability to file a DMF for a biological? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans The guidance requires that API manufacturers establish and monitor impurity profiles. Can the panel explain how this will be done in practice, and especially for APIs where impurities are difficult to characterize, such as biologics? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 8.4 implies that combining several lots of an Intermediate for further processing is not blending, and therefore the individual lots need not be tested for conformance to specifications. Would this hold true for fermentation processes where several lots are harvested and pooled for purification? Does only the pool need to be tested, or must we still we test each harvest to ensure that they are not blending into compliance? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans How does one define actual yield at appropriate phases or times for a fermentation based product? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the periodic monitoring of the cell banks be performed via successful thaw/runs, meaning if the vials from the bank are frequently thawed and expanded, what is meant by determining suitability for use? Full characterization? 1.28K viewsDrugsPharmaceutical « Previous 1 2 … 59 60 61 62 63 … 82 83 Next » Question and answer is powered by anspress.net
