Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How are OOS results in yields dealt with at process start-up for a new campaign? Specifically, how should atypical results be dealt with when they are due to hold ups or…in the initial batch at start-up? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Relative to Section 8.2 on time limits, does stability of a batch under certain processing conditions need to be established by laboratory studies or historical processing data in order not to have to specify time limits? Do max hold times need to be established based on historical data or laboratory stability studies? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans What, if any, stability is expected to be performed on intermediates processed in house? A side question on that is it expected to have retest dates for intermediates that do not leave the company? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Please comment on holding times for intermediates or APIs and the difference between holding times and time limits. 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans The other part of the question was, comment on holding times for intermediates or APIs. 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans If we have other ways to measure the process (e.g. temperature, in process tests, pH, etc), do we have to specify a time limit? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What if a step has no specified time limit in the master production record, but you have an unexplained process delay? While waiting to make a solvent change, if you know that there’s no quality impact, then what sort of deviation or documentation would be expected? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans How does Q7A deal with the addition of seed crystals to induce crystallization with respect to: amount of seed needed and used, type, i.e. particle size distribution of seed material, and documentation. 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans For a critical process parameter, what is the appropriate method of monitoring, continuous or manual? 1.75K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 8.3 regarding OOS. For example, the illustration, your target was to drive to an LOD of 2%, and after a number of hours, the LOD is at 2.5%. Further drying cannot drive the LOD lower than 2.5. Shall the 2.5% be considered as OOS? 1.55K viewsDrugsPharmaceutical 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.? 1.39K 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? 1.55K 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 « Previous 1 2 3 4 5 … 82 83 Next » Question and answer is powered by anspress.net
