Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does the QAU have to be composed of technical personnel? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Should current summaries of training and experience list attendance at scientific and technical meetings? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans For what sequence in the supervisory chain should position descriptions be available? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA preannounce all GLP inspections? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a laboratory’s responsibility for corrective action listed on a FDA-483 begin at the conclusion of an inspection or upon receipt of correspondence from the originating bureau in which corrective action is requested? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans How many copies of the complete laboratory SOPS are needed? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the study director authorize changes in the SOPS? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What amount of detail should be included in the standard operating procedures (SOPs)? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans When an equipment manufacturer performs the routine equipment maintenance, do the equipment manufacturer’s maintenance procedures have to be described in the facilities’ SOPs? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA established guidelines for the frequency of calibration of equipment (balances) used in nonclinical laboratory studies? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What do the GLPs require with regard to facilities for the archives? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Do test and control articles have to be maintained in locked storage units? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that access to animal rooms be limited only to authorized individuals? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that separate animal rooms be used to house test systems and conduct different studies? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require clean/dirty separation for the animal care areas? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for defining study phases and designating critical study phases and can these be covered in the SOP? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a QAU be constituted as a single person? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If raw data are transcribed and sent to the sponsor for (a) preparing the data in computer format or (b) performing a statistical analysis, what are the responsibilities of the QAU? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans What do the GLPs require in regard to assuring the genetic quality of animals used in a nonclinical laboratory study? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans How is the adequacy of bedding materials to be handled? 1.48K viewsDrugsPharmaceutical « Previous 1 2 … 17 18 19 20 21 … 82 83 Next » Question and answer is powered by anspress.net
