Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is Purified Water or Water for Injection the quality of water you are requiring or recommending for use in API production? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Permanently installed pipe work identification: would documentation be a P&ID, or would a process flow diagram be an adequate substitute for labeling individual lines? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Which engineering steps during the planning of a new API plant should be kept, documented, and verified? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the manufacture of API’s require the establishment of air quality standards, HVAC systems specifications to insure no dust migration during the charging of components used in API manufacturing from one reactor to another? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Would it be acceptable to use annual product review as an opportunity to determine which processes and products require revalidation? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 2.5, the product quality review, what is the expectation for the review of critical in process control and critical API test results? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Similarly, what is expected in the product quality review for the review of the accuracy of the corrective actions? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans In the past there has always been a difference between the qualified person as defined in Europe and his or her responsibility and the responsibilities deriving from the education of a person are being seen in the U.S. Can you comment whether this continues to exist and is being seen differently? Basically we’re looking at the European question of a qualified person versus here 1.56K 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? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans What personnel are covered by the training requirement? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss ways in which investigators will assess whether there are an adequate number of personnel. 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Is training using the Internet acceptable? If so, how could it be documented? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Does training record maintenance differ significantly from what is specified by 211? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Are regulators looking for disciplinary action against basic GMP errors made by trained and qualified operators? 1.54K 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? 1.57K 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? 1.44K 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? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans What should approving of contract manufacturers involve? 1.56K 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? 1.38K viewsDrugsPharmaceutical « Previous 1 2 … 8 9 10 11 12 … 79 80 Next » Question and answer is powered by anspress.net
