Toggle Search Form Toggle Menu SHARP > ABOUT > QUALITY ASSURANCE Quality Assurance Our mission is to enable healthcare companies to operate more effectively through international professional outsourced solutions. We empower healthcare companies to operate more effectively and successfully by providing professional, international outsourced services they can trust. Our clients put their reputations in our hands and that is a responsibility we take incredibly seriously. We make quality our highest priority. As industry leaders, it is built into everything we do, for every client, and every member of our team is committed to delivering impeccable standards and results. We guarantee quality by: Complying with or exceeding all regulatory requirements Implementing and supporting quality systems which meet or exceed our clients’ needs Providing ongoing quality training for our professional associates Continuously improving our operational processes and performance Supply Chain and Sourcing Sharp has a strong program for Supply Chain Management starting with the evaluation of each supplier prior to engagement. We have established several reliable sources of packaging suppliers, and most have been in our supply chain for 5 years or longer. A Certified Supplier program was initiated in 2019 to recognize those suppliers who continue to provide Sharp with excellent products for use in our operations. Each supplier is required to meet specific criteria established by Sharp to achieve this status. This process including on-site audit with acceptable results, review of manufacturing and batch record process review with no significant issue, no quality issue identified upon Sharp site inspection for a minimum number of batches. Starting materials are checked by trained quality control personnel at incoming against specifications to ensure the quality of the starting materials and any deficient lots are quarantined. Product Testing Products packaged by Sharp are subject to in-process and release testing, using the test methods and acceptance criteria are agreed with the client. Testing on packaged products is performed by trained personnel and the results are documented in the batch record and are reviewed by the quality department prior to release. Our quality credentials Current Good Manufacturing Practice (CGMP) facilities US Food and Drug Administration (FDA) registered and inspected US Drug Enforcement Agency (DEA) registered and inspected European Medicines Agency (EMA) approved Brazilian National Health Surveillance Agency (ANVISA) approved UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved Need to request information or a quote from us? CONTACT US CLINICAL MANUFACTURING PACKAGING TECHNOLOGY RELATED RESOURCES EVENTS Events we’re attending NEWS Sharp invests $21M to expand US packaging capacity and capabilities NEWS Sharp Strengthens Senior Leadership Team with Two Appointments 1 OUR VALUES Quality Partnership Ingenuity Expertise Energy It’s not just what we do, it’s the way that we do it. TWITTER SHARP_SERVICES NOVEMBER 28TH 2021 Join the Alliance to Zero on December 8th for a webinar on developing a #netzero emissions drug delivery device. https://event.on24.com/wcc/r/3524481/2442F7445BEB9AE3D8A9CF1... NOVEMBER 25TH 2021 In the spirit of the holiday, our colleagues in Bethlehem, PA came together to create Thanksgiving-themed works of art. Happy Thanksgiving from the Sharp family to yours! #thanksgiving #love #health #growth #strength NOVEMBER 18TH 2021 Join our #webinar on December 8th to learn about the ambition of the @AlliancetoZero, understand the methodology and impact the association intends to have, & how pharma suppliers can participate: https://lnkd.in/erHFdf-x @PharmTechGroup @DatwylerGroup @ypsomed @Sharp_Services QUICK LINKS Facilities Serialization Auto-Injectors Careers SOLUTIONS Clinical Clinical Manufacturing Packaging Technology RESOURCES Contact Read our Privacy Policy Candidate Privacy Policy Notice Anti Modern Slavery Statement UDG Supplier Code of Conduct Sustainability policy CONNECT General Enquiries Clinical Enquiries Packaging Enquiries Media Enquiries Ask an Expert Twitter LinkedIn Terms and ConditionsPrivacy PolicyCookiesSitemap © 2021 Sharp. All rights reserved. We Care About Your Privacy By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Accept All Cookies Reject All Cookies Cookies Settings