Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Section 2.8 of OECD Advisory Document Number 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) indicates that where the peer reviewing pathologist’s findings were significantly different from the original interpretation of the study pathologist, a description of how differences of interpretation were handled and changes made to the study pathologist’s original interpretation should be discussed in the final report. Does this apply to both retrospective and contemporaneous peer review? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 2.5 of OECD Advisory Document Number 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) indicates that all correspondence regarding the histopathological evaluation of the slides used for peer review between the sponsor and the representative of the test facility and the peer reviewing pathologist should be retained in the study file. Could the interpretation of this requirement be clarified? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Do software programmes which have been developed by outside vendors or academia to support calculations by test facilities using an OECD Test Guideline, and are referenced in OECD Test Guidelines, need to be validated by test facilities? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Can GLP studies be done in facilities that utilise other quality standards (GMP, GCP, ISO etc.)? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a standard format and content for the Study Director’s statement? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a physical/chemical test system? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans How can the GLP compliance status of a test facility or test site be checked? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans When is it appropriate to look at the contents of a QA report? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans There is no expectation in Q7A to have to audit starting material suppliers. It was also stated that starting material suppliers should be qualified. Does this mean that vendor qualification does not need to include an audit? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans If Q7A does not apply to API starting materials, is it necessary or mandatory to, first of all, audit manufacturers of API starting materials? And B, if an API manufacturer decides to audit the manufacturers starting materials, against which document should the audit be conducted? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans When incoming materials are mixed with existing stocks, for example, solvents. How can a distinctive batch or receipt number be meaningful for purposes of tracking materials used in a specific production batch? And, how useful is assigning batch numbers to such materials when they are mixed? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you do an ID test, such as IR, on polyethylene bags for API packaging, or could you rely on vendor label ID? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans If a material is received from another site within your own company, say a site in another state, do you need to perform an ID test of the material upon receipt? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the expectation for auditing and qualifying a producer of an API starting material from a manufacturer of material made for both industrial and API applications? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans For a non-dedicated tanker, if a Certificate of Cleaning is utilized to ensure no cross contamination, does verification of cleaning need to be performed? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What type of laboratory controls and testing are typically expected of labels and secondary packaging containers? Is visual inspection sufficient? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to physically separate the rejected material or is labeling sufficient? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need separate areas for materials in quarantine or under test? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you validate a method for a toxic or a very dangerous raw material? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to audit a supplier? 1.47K viewsDrugsPharmaceutical « Previous 1 2 … 69 70 71 72 73 … 82 83 Next » Question and answer is powered by anspress.net
