Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is there going to be an attempt to harmonize water monographs in the future? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans What does another unit exactly mean in the distribution procedure? 10.2? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to store equipment cleaning logs and use logs in a single location such as a supervisor’s office rather than in close proximity to the corresponding equipment? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Q7A Section 9.4 makes a “requirement to use tamper evident packaging for shipments outside the company control”. True or false? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the retest date calculated from the manufacturing date or from the release date? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a conflict of retest date definitions among ICH, Q7A and Q1A with respect to immediate use? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Are retains of raw materials used to make APIs necessary or required? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA’s March 1998 draft GMP guidance for API manufacturing defined for antibiotics the use of expiry date. Q7A does not have this recommendation, is this difference existing or not? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What happens if it is not possible to identify an impurity? A new one or one detected…? What happens if it’s just not possible to identify the impurity? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans (Follow-up from floor) That would depend upon the stability of the material? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a retest date be extended without stability data? Can you think of a situation where that might occur? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans (Section 11.2.) Should specs be set for non-critical Intermediates? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans You mentioned that validated methods are not required for raw material testing. Does this mean from Step I materials to the raw materials that enter the final API production step, even the API starting material? Are tests other than ID also required? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an API brought into the country without an expiry date or a retest date on the label of C-of-A considered misbranded? And, is it held on entry in customs? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 11.2, Pharm Forum recently proposed AMC (Aerobic Microbial Count) specifications for all API. Is this appropriate? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans If the inspector asks you to provide the basis for using a three-month-old reference solution in the stability testing of a specific API, what experience and scientific judgment do you defend the utilization of that material? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Shouldn’t all APIs intended for sterile use normally have a specification for microbiological content? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans When, if ever, is parametric release of Intermediates allowed, either to skip testing or reduce testing? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address the need for product-specific Master Plan or the Validation Master Plan? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Should companies maintain accountability of reference standards in the QA labs, i.e. a log of every use amount and date of the reference standard, that is reconciled with the amount of reference standard received. Is this a general expectation? 1.12K viewsDrugsPharmaceutical « Previous 1 2 … 230 231 232 233 234 … 283 284 Next » Question and answer is powered by anspress.net
