Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is the need for Design Qualification (DQ) addressed in Q7A? 1.33K 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? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you apply the statement of IQ/OQ to existing analytical instruments? 1.35K 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? 1.22K 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? 1.14K 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? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans It’s not uncommon for a company to have two suppliers of a starting material. They’re now going to validate the process and they want to make sure that their validation encompasses material from both suppliers. What do they need to consider. 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an acceptable mechanism for confirming the suitability of an alternate source of a starting material? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Can process deviations be used to expand the validation critical process parameter ranges, for one deviation, multiple deviations? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans One of the most critical words used in Q7A in Q7A is “critical”. Is it not essentially implied in Q7A that there be documented bases for identifying critical materials, critical steps, critical operating parameters, etc., whether or not it be called a product development report? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Should process parameter ranges used during validation be tighter than the filed parameters applied to routine commercial production operation, e.g., the full range supported by development? 954 viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of validation work need to be done for a validated API process that stopped producing for five years and produces again? No process or equipment changes are made. Do we need to do stability tests again? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Approaches to Process Validation, the expectation of having at least one validation batch completed at the time of the Pre-Approval Inspection was mentioned. Is this stated in Q7A? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to blend multiple lots that do not have a physical property specification to meet a blended lot physical property specification, example bulk volume particle size? If the material is out of specification for physical properties, can it be blended with other lots to meet these specifications? In all cases, appropriate validation would be conducted. 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans If the only specification not met is expected yield, is blending still acceptable? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an acceptable yield range? ±20%, ±30%, where would somebody find an acceptable yield range? 1.93K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to validate the process in the manufacture of an intermediate? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans May Equipment qualification and equipment validation be used interchangeably to mean the same thing? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans For the cleaning of dedicated equipment in a facility dedicated to the manufacture of a single API, is visibly clean an acceptable criterion for cleaning validation, i.e., no requirement for specific determination of the API? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans In general, do in-process test methods need to be validated? 1.18K viewsDrugsPharmaceutical « Previous 1 2 … 51 52 53 54 55 … 82 83 Next » Question and answer is powered by anspress.net
