Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.21K 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? 1.18K 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 0 Votes 1 Ans At what stage of process development is the validation of viral clearance required? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans For biotech cleaning validation, is it sufficient to validate the cleaning from rinse samples? What additional tests might be considered from swab samples? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans What type of qualification would be expected for steam used to sterilize media in a classical fermentation process? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Representative intermediates or APIs can be used for cleaning validation: does this mean a placebo API might be substituted in the case of very high active or very high value protein production? And, what would be considered representative, only those properties that affect cleaning? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the expectation for process validation being completed before commercial distribution of the final drug the same for CDER and for CBER regulated products? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations when validating the in situ sterilization of culture media in a fermentation process? Is this done in the traditional way when validating an autoclave, for instance using temperature monitoring with thermocouples and biological indicators, or can the sterilized broth be sampled and tested for sterility? 888 viewsDrugsPharmaceutical 0 Votes 1 Ans Should process validation be performed on classical fermentation? For classical fermentation, should the sterilization operation be validated? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans In a classical fermentation, is it necessary to validate the process no matter if we consider the step a non-critical one? The other one is what guidance can you give for validation of classical fermentation processes? What type of factors should be considered for validation? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Would it be expected that the sterilization process of fermenters be validated for a classical fermentation operation? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans In classical fermentation, history would be, the fermentation operation itself is obviously in a closed vessel and the environment around that vessel is non-controlled, quite frankly. I hear you saying, in the biotech area, or the cell culture area, that you’re suggesting or saying that you need at least a 100,000 classification. Can you explain to the people here as to why, number one, that has evolved, and two, are you suggesting that you need that kind of environment than classical fermentation too? 1.21K viewsDrugsPharmaceutical « Previous 1 2 … 241 242 243 244 245 … 283 284 Next » Question and answer is powered by anspress.net
