Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans For what deviations are OOS investigations required: in-process test monitoring, excursions outside the historical range, environmental, critical quality impeaching, intermediate impurity tests (final impurity okay)? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans You mentioned accepting starting materials by performing an ID test in accepting the Certificate of Analysis from a qualified supplier. Could you elaborate on expectations regarding full and reduced testing? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans By full analysis on batches of raw material in order to qualify a vendor, does this mean all the analysis reported on the vendor’s C-of-A or just the analysis we deem critical, i.e. assay, melting point, water, etc.? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to sample raw materials in a controlled environment? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Storage conditions are listed on raw materials for reasons unrelated to GMP, i.e., some solvents are listed at store below 72°F to avoid high vapor pressures that could cause spills upon opening. How might non-GMP-related conditions be delineated to avoid inspector confusion? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Prior to issuing for use, batch production records should be reviewed, dated and signed to prove that it’s the correct version. Can the production department perform this check or does QA need to do it? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Are detailed recipes on the PLC level seen as part of the master instructions? If yes, is review and approval required? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans In Europe, it is common to require only a single signature for critical manufacturing steps. In the batch records, Q7A requires a second person to verify. Which system will prevail in Europe? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans If the QC laboratory releases the bulk of the raw material and then the material is subdivided, does QC have to release it again? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the second review of a critical processing step need to take place at the time the step is performed? Does the supervisor review following the unit operation meet this requirement? 1.65K viewsDrugsPharmaceutical 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 « Previous 1 2 … 49 50 51 52 53 … 283 284 Next » Question and answer is powered by anspress.net
