Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can the user assign retest dates later than manufacturer’s expiration date? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we need to keep reserve samples of starting materials used in API manufacturing? Do they need to keep samples of intermediates if they’re not marketed? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is validation data required in support of blending? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans A company wants to manufacture a blend of chemical actives, where no chemical synthesis extraction occurs. This blend is then sold for use in the manufacture of a consumer product. Is this blend considered an API or does API starting material manifest itself? 977 viewsDrugsPharmaceutical 0 Votes 1 Ans Could you elaborate on section 12.6? Would a change in the source of an API starting material require revalidation? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the quality section need to sign off / approve the validation reports in addition to validation protocols? 955 viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address process development reports? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you give examples of appropriate documentation or other alternate means to indicate the status of equipment? 806 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between “witness” and “verify” in Q7A? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Drug Product Manufacturers may produce placebo product during the PQ-phase to demonstrate the process and equipment are functioning prior to manufacturing commercial product. What is expected in performing a PQ in an API facility? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations for qualifying equipment? For instance, does the OQ need to go to the limit that the piece of equipment is capable of running, or can it just go to the typical operating conditions, i.e., temperature, pressure, etc.? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans We have generalized templates and from there we will take that and add the specific information for the equipment to those templates. We’re wondering if the original templates are signed off after the additional information has been added to the templates, do we need to have an additional review by quality prior to the execution of the IQ? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Can approval of the IQ/OQ protocols be delegated if the template document has been approved by quality? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Are charging operations, even of non-critical materials, considered as critical steps that must be documented and verified? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the need for Design Qualification (DQ) addressed in Q7A? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans There’s a similar question here in talking on IQ/OQ/PQ, if a PQ is performed on a piece of equipment, would you need re-qualification on a yearly basis, or is an one-time PQ acceptable if the equipment remains the same? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you apply the statement of IQ/OQ to existing analytical instruments? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Is retrospective IQ/OQ required for existing equipment that was installed longer than 10 years ago, and has complete preventive maintenance records? In other words, does a formal IQ/OQ document need to be generated or do the PM records and change control suffice? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans In Q7A there are lots of definitions provided in the back. Why are there no specific definitions for prospective or concurrent validation? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Are requirements for GMP compliance, in fact, less stringent for API manufacturers versus dosage form manufacturers: less validation, less cleaning validation, less detailed documentation? Is there any basis for individuals to interpret Q7A this way? 1.03K viewsDrugsPharmaceutical « Previous 1 2 … 50 51 52 53 54 … 79 80 Next » Question and answer is powered by anspress.net
