Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How many hours is full-time employment? How many hours is part-time employment? 1.69K viewsHuman Resources 0 Votes 1 Ans When can an employee’s scheduled hours of work be changed? 2.02K viewsHuman Resources 0 Votes 1 Ans When is double time due? 1.92K viewsHuman Resources 0 Votes 1 Ans Is extra pay required for weekend or night work? 1.56K viewsHuman Resources 0 Votes 1 Ans Are pay stubs required? 1.72K viewsHuman Resources 0 Votes 1 Ans Is Purified Water or Water for Injection the quality of water you are requiring or recommending for use in API production? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Permanently installed pipework identification: would documentation be a P&ID, or would a process flow diagram be an adequate substitute for labeling individual lines? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Which engineering steps during the planning of a new API plant should be kept, documented, and verified? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the manufacture of API’s require the establishment of air quality standards, HVAC systems specifications to insure no dust migration during the charging of components used in API manufacturing from one reactor to another? 1.60K 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? 1.85K viewsDrugsPharmaceutical 0 Votes 1 Ans Is microbiological control in the environmental clean room necessary if the room is not used for injectable grade products? 1.81K 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? 1.71K 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? 1.49K 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? 1.70K 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? 1.75K viewsDrugsPharmaceutical 0 Votes 1 Ans Would validation of critical HVAC controls be expected if there were a separate validated alarm and monitoring system? 2.01K 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? 1.89K 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? 1.83K 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 One of the most common employer complaints about the FMLA is the perception that employees are misusing or fraudulently taking FMLA leave. How can employers protect themselves against potential abuse? 1.63K viewsHuman Resources « Previous 1 2 … 269 270 271 272 273 … 283 284 Next » Question and answer is powered by anspress.net
