Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.28K 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 0 Votes 1 Ans There is no specific definition for critical raw material. Should we combine the definition for raw material and the definition for critical to come up with the criteria? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Why aren’t bulk deliveries of chemicals used in API manufacturing held to the same standards as APIs? There is no validation of clean outs for non-dedicated tankers. 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is statistical sampling a lot for raw materials used for production of APIs sent to Europe? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it appropriate in a batch record to have large spaces, i.e., pages, for handwritten comments to be entered to document observations, etc., as well as spaces for entering data, i.e., tables. 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every operation in a critical step automatically become subject to QA record review? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 1.40K viewsDrugsPharmaceutical « Previous 1 2 … 69 70 71 72 73 … 79 80 Next » Question and answer is powered by anspress.net
