Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans We had an FDA auditor objecting to a remilling of an API because the remilling was not included in the registration as an option. Based on the information provided here, I would understand that this is an acceptable reprocess. 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans How frequently can a rework step be performed before it is considered routine? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Do recovered solvents need to be reused/returned at the same steps from which they were recovered? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans The guideline applies to reprocessing of both conforming and non-conforming materials, what is an example of when you might reprocess in a conforming batch? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans If prior to the finished purification we add to the batch second crops from previous batches or residues from the dryer process of a previous batch, is it not blending? Is it reprocessing? So are we allowed to do this type of reprocessing? 985 viewsDrugsPharmaceutical 0 Votes 1 Ans Does material reprocessed by the filed process get a new manufacturing date under Q7A? There is a school of thought that understands original manufacturing date must be kept. 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Reference standards are extensively characterized in house. When we send these standards to our contract manufacturer, what tests should they conduct on the material received? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Under QA responsibilities not to be delegated, approval of contract manufacturers was listed. The question is, what does this mean? What specific responsibilities does QA have to approve a contract manufacturer? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans For contract manufacturing, is an audit required if the firm has on-site representatives during all the manufacturing at the contractor’s site? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it all right to use contract warehouse space for storage of APIs? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API is supplied from one location to another within the same company for manufacture of dosage form at the other location and quality complaints are received from the dosage form manufacturing location, are these considered complaints as defined in Q7A? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans In Q7A it states that all quality related complaints be recorded. Is there an expectation to record and investigate non-quality related complaints? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you think a recall procedure is really needed at the API manufacturer considering that it will be the API customer accepting or rejecting that API, and in case of rejection, sending the material back to the manufacturer? The real recall will be in charge of the pharma transformer that will put the drug product into the market. 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans When would a retest date be used as opposed to an expiry date? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an expected function from marketing or senior management in responding to complaints or recalls according to Q7A? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans The first bullet point in Section 15 deals with quality related complaints. What about non-quality related complaints? Do they have to be investigated? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you define examples of quality-related complaints? Are they “out of spec” issues only, or what other examples fall under this heading? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the FDA inspect the ABTDR to ensure compliance with GMPs? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans What you suggest in Section 17 may be appropriate, but how can we appropriately regulate nations that seem to freely operate outside the sphere of accepted regulatory practice? Can it truly be effective or is it easily circumvented? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you know if an agent is authorized? 1.32K viewsDrugsPharmaceutical « Previous 1 2 … 238 239 240 241 242 … 283 284 Next » Question and answer is powered by anspress.net
