Questions Ask question Search Order By: ActiveCategoryClear Filter 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 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. 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an acceptable mechanism for confirming the suitability of an alternate source of a starting material? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Can process deviations be used to expand the validation critical process parameter ranges, for one deviation, multiple deviations? 938 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? 1.05K 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? 861 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? 1.29K 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? 1.06K 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. 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans If the only specification not met is expected yield, is blending still acceptable? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an acceptable yield range? ±20%, ±30%, where would somebody find an acceptable yield range? 1.82K viewsDrugsPharmaceutical « Previous 1 2 … 232 233 234 235 236 … 283 284 Next » Question and answer is powered by anspress.net
