Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans For yields and ranges, how do you define appropriate ranges for yield, the percentages? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans If the yield and the quality of an API improved drastically over time without explanation, to what extent should it be investigated? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the agency expect you to adjust your ranges to include the new values? 1.65K 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? 1.46K 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? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What type of proof would be required by an investigator to verify that a supplier has been designated an approved supplier? Would he or she ask for copies of audit reports if audits were performed? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans I have a whole series of questions asking about various materials and whether they should be construed as raw materials or process aids or whatever. We had a question earlier on nitrogen, here’s one on resin and one on argon. 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you test ID for a gas like argon for which there’s no compendial ID test and the manufacturer says this is controlled by their industry by different fittings? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans The questioner is asking about the conclusion that no testing is necessary for toxic materials if transferred within the company’s control, but non-toxic materials transferred within the company’s control would need to be retested and tested again. 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans An API manufacturer performing sampling of its starting material within a room not equipped with any type of air handling system. In addition, there’s no environmental monitoring. Is this acceptable? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Also, no log is kept of the raw materials sampled. Is this acceptable? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Do distributors of raw materials need to be approved and put on an approved supplier list? What is needed? Is an audit needed? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Does three-batch testing of raw material have to include all tests listed on the supplier Certificate of Analysis? If your company’s specifications do not include all of those listed by the supplier, would it be acceptable to test to you specifications? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans May raw materials delivered in tankers be mixed in silos with old batches of the very same raw material after a limited ID testing is performed? Date and time of mixing and identity are, of course, well known. 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Are we expected to QC release polybags, drums and containers and plastic scoops used to scoop and sample APIs? 1.26K 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? 1.32K 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? 1.50K 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? 1.61K 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? 1.54K 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? 1.73K viewsDrugsPharmaceutical « Previous 1 2 3 4 5 6 … 82 83 Next » Question and answer is powered by anspress.net
