Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Please discuss the expectations for equipment qualification for clinical APIs, at what stage of production? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss the expectations to have specifications in place for clinical trials, at what stage? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans For clinical trial APIs, does manufacturer of material versus supplier have to be identified? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it an expectation for analytical methods used to test APIs in clinical trials to be validated? 1.65K 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? 1.50K 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? 1.74K 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? 1.41K 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? 1.61K 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? 1.39K 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? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Clearly while development is underway and early phase clinical batches are being prepared, there is little experience for setting a pre-approval of specifications for intermediate starting materials and process parameters. This can lead to an unreasonable number of OOS investigations especially for the first batch. During this stage, would it be instead acceptable to the regulatory authority to gather information that can be used to assist future specification setting rather than require a hard pass/fail quantification of the materials used? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Does one need to do ID tests on all non-hazardous raw materials for early phase production for solvents, reagents and processing aids? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans How does one determine which parameters, intermediates, etc., are critical in early phase processes where not much is known about the process? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Is analytical validation information required for the assay of the API in the FPP 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Is analytical validation information for the assay of the API required to be submitted with the dossier? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans For equipment infrequently used to manufacture materials for research, toxicity studies, or Phase I clinical trials materials, how detailed should the cleaning validation be or is visual examination sufficient when toxicity is often unknown? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans If you have a validated process using commercial scale equipment, but have material manufactured in small scale or pilot scale equipment following the same process, can you use this material for commercial drug product? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Cleaning for clinical trials. For phase I facilities, what is considered satisfactory equipment verification? How much validation is required for swabbing? What is the GMP expectation for cleaning residue limit, i.e., is .05% of the batch size considered to be adequate? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Would it be sufficient to assure equipment is clean and validation not executed for the cleaning procedure when clinical trial lots are manufactured in facilities used for commercial API production where other cleaning procedures were validated? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Slide 19.2 states that R&D frequently performs testing. If so, is the lab subject to inspection and expected to be GMP compliant. Should QC still be responsible for review and approval of data and the resulting C of A or just QA disposition based on R&D? 1.61K viewsDrugsPharmaceutical « Previous 1 2 … 244 245 246 247 248 … 283 284 Next » Question and answer is powered by anspress.net
