Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is the expected frequency of testing of High Purity Water systems, such as Purified Water with Endotoxin Control: daily, weekly, bi-weekly, monthly, etc., for point of use sampling? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans For Intermediate processing, comment was made that the processing of potentially toxic, i.e. pesticides, was not that significant an issue. Can a company support such an activity? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the Q7A Section 3 on personnel directly apply to laboratory and QA personnel, i.e., adequate number of qualifications, etc., or is it intended to apply only to the manufacturing personnel? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans What personnel are covered by the training requirement? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss ways in which investigators will assess whether there are an adequate number of personnel. 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Is training using the Internet acceptable? If so, how could it be documented? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Does training record maintenance differ significantly from what is specified by 211? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Are regulators looking for disciplinary action against basic GMP errors made by trained and qualified operators? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the fact that training should be periodically assessed mean testing of individuals or watching the individual perform the operation? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Please expand on the definition of consultant. Can we exclude persons who are contractors that work under direct supervision of company employees? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Please give an example of what qualified means to a laboratory technician. Is it ten years experience? Is it a BS in chemistry? Is it documented training on certain LC and GC analysis or is it some sort of combination of all of that? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify the meaning of “training should be periodically assessed”. Does this mean competency assessment of those being trained, i.e. post-training assessment? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans If the laboratory is part of the quality unit, Then the procedures, test methods, equipment, etc., must be approved by the quality unit in addition to the person in the laboratory? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans In the non-delegateable activities, does that mean that I cannot have a quality control laboratory as an external supplier? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the responsibilities not to be delegated by QA apply to both clinical and commercial APIs? For example, do manufacturing instructions require QA approval prior to commencement of the manufacturing step? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What should approving of contract manufacturers involve? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans You mention the audit expectation for API starting material suppliers. What do you expect from audits of API suppliers by drug product manufacturers? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there no need for environmental monitoring such as occupational hygiene monitoring for API manufacturing? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Please further clarify the scope of QA and the approval of master production instructions versus the production review and approval. 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it ever appropriate for the quality unit to make sure that the Product Quality Review is performed by another group or is this an activity not to be delegated? For example, review of in process controls, critical API results performed by protocol, approved by the quality unit, issued from technical operations, a group that does not report directly to the quality unit. 1.65K viewsDrugsPharmaceutical « Previous 1 2 … 75 76 77 78 79 … 82 83 Next » Question and answer is powered by anspress.net
