Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.61K 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 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 For clinical APIs, should vendor test results on the Certificate of Analysis be confirmed by in house testing? 1.37K viewsDrugsPharmaceutical 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 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 « Previous 1 2 … 243 244 245 246 247 … 283 284 Next » Question and answer is powered by anspress.net
