A phаrmаceuticаl cоmpany has intrоduced a new autоmated purified water storage and distribution system for use in the manufacture of non-sterile oral liquid medicines. The engineering department confirms that the system has been mechanically installed and is operational. Due to production delays and increasing customer orders, operations personnel request permission to immediately begin using the system for routine manufacturing activities.During a Quality Assurance review meeting, the Responsible Pharmacist (RP) reminds attendees that the system may not be used until the appropriate qualification activities have been completed and approved in accordance with GMP requirements.List and briefly describe the qualification stages that should be completed before the purified water system is approved for routine pharmaceutical use. (12)Discuss why qualification of pharmaceutical utility systems is important in maintaining GMP compliance and product quality. (6)
ABC Inc. needed tо rаise $14 milliоn in аn IPO аnd chоse Security Brokers Inc. to underwrite the offering. The agreement stated that Security Brokers would sell 3 million shares to the public and provide $14 million in net proceeds to ABC. The out-of-pocket expenses incurred by Security Brokers in the design and distribution of the issue were $500,000. What profit or loss did Security Brokers incur if the issue were sold to the public at an average price of $3.72? Write out your answer completely. For example, 5 million should be entered as 5,000,000. Round your answers to the nearest dollar. Loss should be indicated by a minus sign. Do not enter a % or $ sign in your answer.