Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Section 50.6.4 states that Sponsors may conduct a risk assessment for auditing FDRs. Does this statement apply only when the sponsor has a large number of first tier entities and only audits high-risk first tiers? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans To the extent that Part D sponsors do not use either pharmacists or pharmacy technicians to conduct audits or monitoring activities involving Part D operations (i.e.., formulary administration, coverage determinations, appeals, and grievances, etc.), would this be a potential finding in the compliance area? 945 viewsDrugsPharmaceutical 0 Votes 1 Ans The list in Chapters 9 and 21 provide examples of reports that Sponsors should receive, and seem to be focused on identifying fraud, waste, and abuse. Should the Sponsor receive similar reports from its FDRs as it relates to ongoing compliance with Medicare C/D operational functions (i.e., enrollments, organization/coverage determinations, appeals, grievances, call center compliance, etc.) that have been delegated to a first-tier or downstream entity? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans What does the 10 year record retention include? As for the Compliance Program Guidelines, most of our FDRs believe this only pertains to FWA training. They are citing that for any audit conducted of them under 50.6.11, they would only have to retain FWA Training. Should they not be keeping general compliance training and disciplinary actions taken on non-compliance, as well as basically any documents pertaining to day-today operations of their organization? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans A Vision Vendor (first tier) for a Sponsor is required to conduct monthly OIG/GSA verifications on all their employees, temporary employees, volunteers, consultants, etc. However, are they required to carry the requirement forward to their contracted providers, i.e., XYZ’s Optical’s entire organization? Should the Vision Vendor conduct audits of their provider network to ensure the provider’s entire staff is being verified through OIG/GSA on a monthly basis? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans We treat monitoring reviews and audits as interrelated because they pertain to the same regulations and we use the same criteria to conduct both. Would it be acceptable during a CMS Compliance Program audit for us to demonstrate to CMS that we use monitoring reviews and audits interchangeably as evidence of an effective program, as long as both are comprehensive and routine? 868 viewsDrugsPharmaceutical 0 Votes 1 Ans We currently do not track who has read the SOC. Would it be appropriate if we took a sample of 30 employees and verify they have read and understood the SOC or must we receive confirmation from all employees? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Using real-life examples, please clarify the distinction between ongoing monitoring and auditing of FDRs. 898 viewsDrugsPharmaceutical 0 Votes 1 Ans Using real-life examples, please clarify the distinction between ongoing monitoring and auditing of FDRs 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify when it is permissible for FDRs to perform their own audits. 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Also, no log is kept of the raw materials sampled. Is this acceptable? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans An API manufacturer performing sampling of its starting material within a room not equipped with any type of air handling system. In addition, there’s no environmental monitoring. Is this acceptable? 1.19K viewsDrugsPharmaceutical 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. 935 viewsDrugsPharmaceutical 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. 1.16K viewsDrugsPharmaceutical « Previous 1 2 … 43 44 45 46 47 … 79 80 Next » Question and answer is powered by anspress.net
