Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can an older version of an official method be used or must the most updated version always be used? 931 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on the use of secondary reference standards (RS) and what are the conditions for the use of secondary reference standards? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What documentation does a laboratory have to have in place to be considered qualified to run a test method for raw materials (drug substances and excipients) in order to satisfy Health Canada Regulations? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the sampling plan based on the (/n+1) acceptable for identifying the number of containers of raw material to be sampled? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans If we already test each batch of our finished product for the absence of Staphylococcus aureus and Pseudomonas aeruginosa, is it required to test it also for the purified water? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a single lot number be assigned to two or more co-mingled lots of bulk finished drug products packaged during the same run? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the acceptable deviation in physical counts of finished product stock? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans When are independent checks by another operator necessary? 973 viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations on label accountability? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is verification of empty containers an acceptable check for addition of ingredients? 889 viewsDrugsPharmaceutical 0 Votes 1 Ans Are quarantine and release stickers required on all containers of raw materials and packaging materials? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an answering machine acceptable for recall activation outside normal working hours? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to document quantities by lot numbers of finished stock destroyed? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a standard on what should be stated in a recall procedure? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans May firms omit second person component weight check if scales are connected to a computer system? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans What are requirements of maintaining an impurity profile? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every individual container of a raw material need to be sampled for identification (ID) purposes regardless of the number of containers of the same lot available or are composite samples acceptable provided they are obtained from a maximum of 10 containers? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans An active pharmaceutical ingredient (API) can be used after the retest date assigned by the API fabricator if a re-analysis done immediately before use shows that it still meets its specifications. Can the new data generated be used by the drug fabricator to assign a longer retest date to future lots of this API obtained from the same fabricator? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans What about inactive ingredients? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans With respect to the re-test date of the drug substances, we have the stability data of a drug substance for up to 24 months at real time stability condition. The re-test period is assigned up to 24 months. According to the “Evaluation of Stability Data – ICH Q1E”, 2.4.1.1(the proposed retest period or shelf life can be up to twice, but should not be more than 12 months beyond, the period covered by long-term data), the retest period can be assigned up to 36 months. Can we assign the retest period up 36 months? If yes, does it require retesting of the active pharmaceutical ingredient (API) at 24 months? 931 viewsDrugsPharmaceutical « Previous 1 2 … 40 41 42 43 44 … 79 80 Next » Question and answer is powered by anspress.net
