Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Staying with out favorite subject, does this section apply to customs brokers and shippers? The definition seems to apply. 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans I believe that most at this meeting would agree that it would a mistake for a body to attempt to write guidelines for the API industry without having representatives from the API industry involved. Other than the ability to provide comments on step two, did the industry participate in writing of Section 17? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Why was Section 17.5 included? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Can all starting materials be considered equal? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Adenoviruses. Are they considered whole cell and thus excluded from Q7A? 1.06K 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? 1.31K 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? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it anticipated that these products would eventually be covered by this guideline? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Why are human plasma-derived protein products specifically excluded from the Q7 guidelines? 1.26K 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? 940 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 It was mentioned that cell culture fermentation was one of the two differences between Q7A and the FDA’s previous draft guidance.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. 1.34K 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? 1.12K 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? 1.35K 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. 1.08K 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? 1.40K 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? 1.19K viewsDrugsPharmaceutical « Previous 1 2 … 240 241 242 243 244 … 283 284 Next » Question and answer is powered by anspress.net
