Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Drug product manufacturers rinse manufacturing equipment with purified water. Should API manufacturers rinse finishing equipment such as mills and blenders with purified water? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Is microbiological control in the environmental clean room necessary if the room is not used for injectable grade products? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans The new EMEA note for guidance on water has some clauses around APIs and water qualities that are tighter than the Q7A guidance. How should companies interpret these two guidances? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding closed systems for APIs in the same room allowing for multiple products to be manufactured in that same room, is that just different lots of the same product or different chemical entities or reactions? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans We’ve heard Europe has defined a fourth level of water purity called highly purified water, which seems to be aimed toward the production of APIs. What impact will this have on the other ICH regions and Q7A if any? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 4.4. For material of high pharmacological activity or toxicity, dedicated production areas should be considered unless there is validated inactivation or cleaning validation. Is there an amount or a method for determining if your compound is considered highly potent? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Would validation of critical HVAC controls be expected if there were a separate validated alarm and monitoring system? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans In design and construction, is there any topic under the subtitles regarding local hazards because of adjacent units, adjacent companies, which are involved in nonpharmaceutical operations? Say dyes for the textile industries or rubber industries and the like that are located in the same chemically zoned industrial district as the plant? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans If you’re using electronic systems for control of materials, exactly what physical segregation or physical separation of products and areas is needed? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans For nitrogen gas, which is being used for vessel-to-vessel transfer. What qualification is required? Anything besides IQ, OQ and PQ? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans What dosage forms for zinc sulfate are being sought for prequalification? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the minimum stability requirements for the API and FPP? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any API specification requirements for zinc sulfate? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans In a multi-step API manufacturing process, can charging operations for earlier noncritical steps be done outdoors, as long as the last several critical steps are done indoors? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the expected frequency of testing of High Purity Water systems, such as Purified Water with Endotoxin Control: daily, weekly, bi-weekly, monthly, etc., for point of use sampling? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans For Intermediate processing, comment was made that the processing of potentially toxic, i.e. pesticides, was not that significant an issue. Can a company support such an activity? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the Q7A Section 3 on personnel directly apply to laboratory and QA personnel, i.e., adequate number of qualifications, etc., or is it intended to apply only to the manufacturing personnel? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans What personnel are covered by the training requirement? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss ways in which investigators will assess whether there are an adequate number of personnel. 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Is training using the Internet acceptable? If so, how could it be documented? 1.31K viewsDrugsPharmaceutical « Previous 1 2 … 74 75 76 77 78 79 80 Next » Question and answer is powered by anspress.net
