Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 890 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 It was mentioned that cell culture fermentation was one of the two differences between Q7A and the FDA’s previous draft guidance.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. 1.29K 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? 1.07K 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? 1.28K 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? 1.28K 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. 1.06K 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. 1.03K 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? 1.12K 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? 1.34K 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? 1.14K 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? 1.16K 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? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans How does one define actual yield at appropriate phases or times for a fermentation based product? 1.11K 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? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans If microbiological standards have been established (this refers back to Section 4.1) where should the specifications be established? Please provide some examples of where microorganisms have affected a product’s suitability for its intended use and micro specs may have prevented the incident. 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding contamination, if incomplete discharge of fluids in a biotech process occurs upon transfer of the material to the next step in the process, microbiological contamination could be a risk. Therefore, this type of contamination could be unacceptable, yes or no? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Could you address the subject of water quality? Would it be acceptable to use “softened” water versus Purified Water for fermentation/cell culture activities, with Water For Injections used for subsequent purification steps? What types of testing data would be expected on this soft water, i.e., if it meets the lot criteria for Purified Water but was not processed as Purified Water? The use of water, USP, which meets all the test requirements of WFI or Purified Water, but which is produced in a different fashion acceptable for biotech APIs? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the appropriate level of control for materials used to increase biomass and prepare inoculum? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans For components of fermentation media, such as Casein Digests, what constitutes a specific identity test and, is it necessary if you have an appropriately qualified supplier? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Could you clarify the distinction between the starting material for chemical synthesis of an API and a source material? For example, a component of a fermentation medium used in the manufacturer or biological API. In the latter case, is audit and qualification of a supplier expected? 1.16K viewsDrugsPharmaceutical « Previous 1 2 … 59 60 61 62 63 … 79 80 Next » Question and answer is powered by anspress.net
