PPT-Good Manufacturing Practices

A Regulatory Perspective Presented By Ashok Kumar Dua Plant Head Unichem Laboratories Sikkim GMP Good Manufacturing Practices Till yesterday everything was fine . Executive Summary Manufacturing has evolved by embracing highly re64257ned processes for planning and execution This has helped many manufacturers rapidly improve their operational effectiveness and productivity while removing waste from each and ev fdagovCosmeticGuidances You may submit written comments regarding th is guidance at any time Submit written comments on the guidance to the Division of Dockets Management H FA305 Food and Drug Administration 5630 Fishers La ne rm 1061 Rockville MD 20 How Frost & Sullivan’s Manufacturing Leadership Community Will Help Companies Grow in Today’s . & Tomorrow’s Global . Market . The Journey to Visionary Innovation. The Frost & Sullivan Story. Joel Semeniuk. Imaginet. Microsoft MVP – Team System. Microsoft Regional Director. History. Lesson. Kiichiro Toyoda. Son of . Sakichi. Toyoda. Taiichi. . Ohno. Answered the Challenge – Developed a Method Evolved Into Toyota Production System. for. . Pharmaceutical . Manufacturing. . Dr. M. . Rahman. NIPER, . Guwahati. .. Objectives. To understand where the regulations come from, . who . has enforcement authority, and . why . you need to. countries. Examples . of . and ideas for synergetic . DRR and CCA measures and . practices. 1. st. afternoon . session. DRR: institutionalized . in laws, . governmental bodies; . mostly with a long . Hank Canitz. Sr. Director Manufacturing Industries, QAD. QAD Explore 2012. 2. The following is intended to outline QAD’s general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for QAD’s products remains at the sole discretion of QAD.. Software Orientation Slides. Topics. Batch Production Record Workflow. Purchasing . Material Receipt. Batch Production. Inventory. Summary. Overview. Purpose of GMPs. Quality Systems. GMP Process Flow. & Quality Assurance :. GMP&QA. The GMP is enforced through Quality Management System (Q.M.S.) . The QMS starts with the concept of Quality Policy & Quality Manual. 1. 3.. QMS (Quality Management System). Navigating the University: Research and Resources Management Retreat. August 19, 2016. Michael Jamieson . DRSc. Associate Director, International Center for Regulatory Sciences. Assistant Professor, Clinical Pharmacy. Why GMP?. Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality. Medicines are manufactured to comply with their marketing authorization. December 2015. Session Outcomes. Share good . practices . to:. Attract new . members. Retain . existing members. . Through demonstrating a . vital . and . attractive club life. Session Overview. Part 1: What is a vital club life?. Project Team. : KYFAME* Leadership (Josh Benton), . UK (Dr. Badurdeen). ,. . MSU (Mark Horstemeyer), Purdue (Dr. Sutherland), WVU (Gopala); open invite to other universities; Lexmark (Dan Seevers), OSU/Gold1 (Dr. Goldsby), find contact for UT, Kettering (Terry Lynch), Alabama. STANDARDS FOR CURRENT GOOD MANUFACTURING PRACTICE. *. Current Good Manufacturing Practice (. cGMP. or GMP) regulations are established by the Food and Drug Administration (FDA) . to ensure that minimum standards are met for drug product quality in the United States.