Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Earlier, it was stated that QA approval was not required for manufacturing procedures for clinical trial material. What is the justification for this difference between commercial and clinical materials? And, at what point in the development process is it expected that master procedures be generated? Once they exist, should an independent QA unit approve them? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GMP expectations for a development facility or an API supplier who manufactures a lot of API in that facility to be used for an exhibit batch for an ANDA submission? Would the concepts for API clinical trials be used here? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans In a commercial process, can a non-conforming Intermediate be used if lab use tests show the drug substance is within specifications? Sometimes, even in production, you set the specs for Intermediates. Sometimes the Intermediate batch did not meet the specs for Intermediates. But then you do another few tests, and the drug substance derived from that batch looks good. It passes all the specifications for the drug substance. Can you consider that compliant to a GMP or is it not? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans What level of equipment qualification is recommended for clinical APIs? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Do all lots of APIs used in clinical trials need to be put in a stability study? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans If you take the same scenario from the previous question back into development, talk a little bit about how Q7A GMP guidance would be applied there. 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Assume a 13-step process, in which step 8 is registered as the point where API starting material is introduced. Between steps 8 and 12, there are materials, including critical Intermediates, used. If the Intermediates are obtained from suppliers or manufacturers known not to have GMP facilities, applying Q7A’s sliding scale of GMP-ness, will this be interpreted as non-compliant or contrary to the spirit of Q7A? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you comment on why there are so few specifics in Section 19 and it’s so general in nature? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans APIs in clinical trial material – I fail to see the logic of employing a use test to release raw materials. If you use a material without some form of analysis and it turns out to be contaminated, the yield of your reaction may be what you expect, but the contaminant may still be present and go undetected by your analytical method for the API or Intermediate. 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Can development batches produced prior to validation be used for validation of the drug product or commercially? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss the expectations for equipment qualification for clinical APIs, at what stage of production? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss the expectations to have specifications in place for clinical trials, at what stage? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans For clinical trial APIs, does manufacturer of material versus supplier have to be identified? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it an expectation for analytical methods used to test APIs in clinical trials to be validated? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans For early clinical material, if reprocessing occurs during a batch, but this reprocessing step is not yet validated, can the batch be released if it is found, during an investigation, that there is not product impact? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA expectation for process validation of clinical trial materials after an NDA is approved? Example, for a product line extension using pilot batches of APIs? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it required to use qualified suppliers audited by the company in clinical trial batches? All suppliers including solvents, etc., or just critical materials? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 19, For Phase I contract manufacturers, are OOS investigations required? At this stage, all methods are non-validated so how can you have specifications? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Do clinical trial APIs require expiry date and retest date? What if it’s not known or on concurrent stability? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans By which clinical phase should API methods be validated? And two, would you recommend the same guidance for drug product method validation for clinical phase? 1.20K viewsDrugsPharmaceutical « Previous 1 2 … 62 63 64 65 66 … 79 80 Next » Question and answer is powered by anspress.net
