Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does the ICH provide guidance on the determination of cleaning limits, residual limits? 1.64K viewsDrugsPharmaceutical 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? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Is microbiological control in the environmental clean room necessary if the room is not used for injectable grade products? 1.44K 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? 1.63K 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? 1.70K 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? 1.65K 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? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Would validation of critical HVAC controls be expected if there were a separate validated alarm and monitoring system? 1.45K 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? 1.31K 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? 1.41K 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? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans What does adequate protection in Section 4.1 and adequate filtration in Section 4.2 mean? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans There are several questions here that relate to standards for clean room classes and are asking about regulations or specific guidances that identify either where they’re needed or about design requirements for room classifications, Class 10,000, etc. 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Please give an example of what qualified means to a laboratory technician. Is it ten years experience? Is it a BS in chemistry? Is it documented training on certain LC and GC analysis or is it some sort of combination of all of that? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify the meaning of “training should be periodically assessed”. Does this mean competency assessment of those being trained, i.e. post-training assessment? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What dosage forms for zinc sulfate are being sought for prequalification? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the minimum stability requirements for the API and FPP? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any API specification requirements for zinc sulfate? 1.57K 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? 1.55K 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? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 7 8 9 10 11 … 79 80 Next » Question and answer is powered by anspress.net
