Questions Ask question Search Order By: ActiveCategoryClear Filter 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. 1.11K 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? 1.15K 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. 934 viewsDrugsPharmaceutical 0 Votes 1 Ans When making corrections to documented entries, the only requirements are to sign, date, and leave original entry readable. Was there any discussion when writing Q7A to also record the reason for the change? Will field investigators expect this? 1.64K viewsFDA 0 Votes 1 Ans Does Q7A consider 21 CFR Part 11, and what is the regulatory status for compliance when inspecting an API manufacturer? Does Q7A specifically address or imply compliance requirements? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Vendors of new equipment often ship you a vessel that has been polished. Often they do not know the chemical constitutes of the polish or of the gases. Our approach to cleaning, in this case, is use of a non-polar solvent to remove organics followed by a polar solvent to remove inorganics. Is this acceptable? 1.28K 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 901 viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment and computerized systems are not part of the term material, so suppliers of critical equipment and computerized systems do not need to be approved. 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Typically an API manufacturer performs quality tests on intermediates. If it passes, then QC will release the intermediate for the next synthesis step. The quality unit then reviews the entire batch records at the end and releases the final API. It seems that Q7A requires that the quality unit review the batch records and test results at each step, prior to moving to the next step. This may not be practical in some cases. 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans When and where do we start applying CGMPs? For example, we may use isopropanol to make the reaction of our API or to purify API. We do not manufacture isopropanol, so does the manufacturer of isopropanol have to follow all the CGMPs that apply to us? Does the manufacturer of any excipient have to follow the CGMPs as we do? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Was I wrongfully terminated? – I was terminated from a medical facility after 8 years for a clerical error I was mailing out lab requests and new patient paper work . I printed patient appointment labels instead of address labels. They were sent to the mail room and out to the post office and sent back for no address return to sender. I was terminated for printing and mailing. I had no idea of this error and felt I was set up. Do I have any rights at all? 1.71K viewsHuman Resources 0 Votes 2 Ans If the conductivity is 1.31 microSiemens per cm at 25C is it out of specs already; USP says 1.3 microSieat 25C 1.20K 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? 1.06K 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? 1.23K 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? 1.17K 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? 1.16K 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? 1.22K 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? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to sample raw materials in a controlled environment? 830 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.? 1.21K viewsDrugsPharmaceutical « Previous 1 2 … 225 226 227 228 229 … 283 284 Next » Question and answer is powered by anspress.net
