Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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. 1.46K 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 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? 1.65K 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? 1.56K 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? 1.24K 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. 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify the wording under documentation (19.9), where it says, “Ensure information gained during development and manufacturing is documented and available”. What is the difference between development and manufacturing? The way I would understand manufacturing is when I make the batches. What is development then? Making the clinical batches? What does the word development refer to here where it says the development must be documented? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Should there be second party review of batch records and lab data by QA for clinical materials? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans For multi-use or multi-product equipment used to make clinical trial materials, would you expect the analytical methods used to verify removal of the previous API to be fully validated, and would you expect reference standards to be fully characterized? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans When will the Agency start inspections of clinical trial manufacturers using these guidelines? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans It is good to see in ICH guidelines a set of requirements for APIs that ought to be used in clinical trials. It is noted in Section 19.1 that process and test procedures should be flexible. Would the panel please comment on the interpretation of flexibility? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans If a process is out of the scope of Q7A, i.e., master cell bank establishment, will those processes be or that process not be covered in FDA inspections? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Who regulates classical fermentation? Is it CBER or CDER? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Q7A is the only ICH guidance that provides input on development of ICH for registration. What was the thinking of the EWG that led to inclusion of Section 19? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans In Section 19.6 does the applicant need three different batches of the API to make their demonstration lots? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans For clinical APIs, should vendor test results on the Certificate of Analysis be confirmed by in house testing? 1.38K viewsDrugsPharmaceutical « Previous 1 2 … 61 62 63 64 65 … 79 80 Next » Question and answer is powered by anspress.net
