Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Please comment on the environmental monitoring and air space classification in facilities generating API from MMC (assuming that mammalian cell culture, and fermentation processes). There is a breadth of practice and inspectional findings in the industry. 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans How stringent must the environmental monitoring program be for the biotech API facility? Do you expect to see the same level of monitoring that is done in a filling facility? Is passive monitoring sufficient? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What type of controls/room classifications/gowning, etc., would you expect for a media prep area of a dedicated biotech facility, especially if the media raw materials have a known but unpredictable level of bioburden? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans The integrity test on the final sterilizing filter for parental products is required to be implemented in situ. However, it is hard to do because they’re a big facility consisting of many cartridges. Is an off line test instead of an in situ test acceptable? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the product of a classical microbial fermentation be classified as a starting material in the preparation of an API? It kind of gets to both the small molecule as well as fermentation. 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is systemic autoclaving part of routing materials into a Class 100,000 facility? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans In the case of mammalian cell culture where inherent viruses must be removed during purification, to what extent does the equipment suites, etc. need to be segregated? 986 viewsDrugsPharmaceutical 0 Votes 1 Ans For APIs that are small molecules, as long as your reactor is closed and what is outside the reactor does not really matter, what you really care about is what the API sees (if you pretend you are the API). With biological processes, it tends to be a little tighter specification, is that what you’re getting at? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Biotech API (manufacturing, fermentation, primary recovery, and purification) where closed unit operations are used could be manufactured in facilities with lower environmental classifications than many of the facilities currently found in the biotech industry. Many biotech API facilities with closed unit operations have been built to ensure drug product environmental standards. Comments? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans During the purification process of some recombinant proteins, affinity chromatography techniques with monoclonal antibodies are used. It’s well known that leakage of antibodies frequently expected that would contaminate the API. How can this possible contamination with another biologically active entity be considered under control in order to validate the process? Is this procedure regarded by the Q7A as an appropriate procedure since it incorporates contaminants into the API production process? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Assuming quality systems are operational, please comment on the fate of product when PQ requires actual API processing. Can it be sold provided successful validation follows and specs are met? Examples would be chromatography and those types of steps. 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans We currently manufacture a non-sterile bulk active biological product derived from the fermentation of a non-recombinant microorganism for the European markets. If we sought registration for the U.S. market, would FDA inspect under Q7A or 211 CFR? It goes on to say that our UK partner’s license holders formulate and finish the product. 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Was the combining of chromatography fractions to meet a specific percent of purity discussed in regards to blending, and if so, what was the outcome of the discussion? It is a blending question, that is correct, but in this particular case, instead of talking about tailings or yields out of our normal API chemical processes, this happened to involve chromatography. 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans For fermentations that are long, 300 plus hours, complicated and produce products with no anti-microbial activity, a foreign growth bacterial contamination level of 10 to 15% is difficult to impossible to maintain. Can you comment on this level of foreign growth and your recommendations? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans If a biologics (API) batch for clinical study use was already manufactured, does the FDA still require sterility test if it wasn’t tested before it was used in the manufacturing process of the drug product? If yes, the risk of drug contamination increases. Would they still require a sterility test, or is a passing a test of zero bioburden conducted prior to (drug product) manufacturing sufficient? Drug contamination can occur when taking the drug through the sterility testing room because the package will go through vigorous cleaning processes using harsh chemicals. Then, when the drug is ready for packaging, these harsh chemicals may break through and contaminate the drug product. 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there still a requirement for virus removal and activation when there are no animal derived components in the manufacturing process? That is no bovine serum albumin in the media. That’s the first part of the question. Is there ever a requirement for redundant virus removal in an inactivation step? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 18.5 refers to viral removal and viral inactivation steps, and refers to Q5A. Has FDA determined if validation of inactivation of mammalian model viruses is required for insect cell culture processes, since the growth temperature of insect cells would not allow replication of mammalian viruses, it is not appropriate though Q5A seems to imply it is? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the out of spec procedure as required by Q7A also require OOE or out of expectation investigations? If so, what is the definition of OOE? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Early clinical batches may be produced in laboratory equipment as opposed to plant facilities because of limited batch size requirements. What are the expectations for environmental controls in laboratory facilities versus pilot plant? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans I think what we may be confusing here is, I might do development batches – process development – and never intend to put those into a clinical trial. Then, after I’ve developed the process somewhat, I will manufacture batches to put into a clinical trial. So the concern is that, is ICH Q7A saying here that there will be some GMPs applied to that development work? Clearly, I think the answer’s no. 1.46K viewsDrugsPharmaceutical « Previous 1 2 … 242 243 244 245 246 … 283 284 Next » Question and answer is powered by anspress.net
