Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans It’s not uncommon for a company to have two suppliers of a starting material. They’re now going to validate the process and they want to make sure that their validation encompasses material from both suppliers. What do they need to consider. 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an acceptable mechanism for confirming the suitability of an alternate source of a starting material? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Can process deviations be used to expand the validation critical process parameter ranges, for one deviation, multiple deviations? 938 viewsDrugsPharmaceutical 0 Votes 1 Ans One of the most critical words used in Q7A in Q7A is “critical”. Is it not essentially implied in Q7A that there be documented bases for identifying critical materials, critical steps, critical operating parameters, etc., whether or not it be called a product development report? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Should process parameter ranges used during validation be tighter than the filed parameters applied to routine commercial production operation, e.g., the full range supported by development? 861 viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of validation work need to be done for a validated API process that stopped producing for five years and produces again? No process or equipment changes are made. Do we need to do stability tests again? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Approaches to Process Validation, the expectation of having at least one validation batch completed at the time of the Pre-Approval Inspection was mentioned. Is this stated in Q7A? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to blend multiple lots that do not have a physical property specification to meet a blended lot physical property specification, example bulk volume particle size? If the material is out of specification for physical properties, can it be blended with other lots to meet these specifications? In all cases, appropriate validation would be conducted. 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans If the only specification not met is expected yield, is blending still acceptable? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an acceptable yield range? ±20%, ±30%, where would somebody find an acceptable yield range? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to validate the process in the manufacture of an intermediate? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans May Equipment qualification and equipment validation be used interchangeably to mean the same thing? 947 viewsDrugsPharmaceutical 0 Votes 1 Ans For the cleaning of dedicated equipment in a facility dedicated to the manufacture of a single API, is visibly clean an acceptable criterion for cleaning validation, i.e., no requirement for specific determination of the API? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans In general, do in-process test methods need to be validated? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Q7A is titled “Good Manufacturing Guidance for Active Pharmaceutical Ingredients”. Why does it not include the reference to “current” as in 21 CFR 211? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Please explain why combining several centrifuge loads from a batch is not considered blending in Q7a. 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans How is blending of small batches to increase batch size different from combining fractions from several batches of intermediate for further processing? 919 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to validate at a scale less than that of the commercial process (e.g., 10%)? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss re-validation as it relates to scale-up. If the same equipment is used, is there any restriction on how much the scale can be increased prior to re-validation? If similar but different equipment were used, would re-validation be required? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans A batch of new API is produced prior to validation. Can this batch be used for commercial distribution after completion of validation of the API process? 1.08K viewsDrugsPharmaceutical « Previous 1 2 … 51 52 53 54 55 … 79 80 Next » Question and answer is powered by anspress.net
