GMP Institute - The Global Leader For GMP Training
Compliance and performance are the goals of every food, drug, cosmetic, blood, and medical device manufacturer. But they don't just happen. They are achieved when FDA's Good Manufacturing Practice Regulation becomes a lifestyle shared by everyone in the organization. Compliance and performance occur only if facilities strive toward a proactive management system. All of our products and services, are geared to help you make GMP a lifestyle, not just a regulation. It is from this perspective that we confidently assert: Our Commitment Is To Your Success!
Please bookmark our website as one of your favorite places, and check it often, as we intend to continue to provide you with new resources. In addition to being able to find information on who we are and what products and services we offer, we also have included sections to help you understand and keep current with compliance, performance, managing, training, and auditing to help you do your job better.
Need To Brush Up On GMP?
News:
Amendment to the Current Good Manufacturing
Practice Regulations for Finished Pharmaceuticals; Withdrawal of Direct
Final Rule [HTML] [PDF] (4 April 2008)
Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements; Technical Amendment [HTML] [PDF] (12 March 2008)
FDA Is confirming
the effective date of 19 February 2008 for the direct final rule that
appeared in the Federal Register of 16 August 2007 [HTML
] [PDF] (8 February 2008)
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice [HTML] [PDF] (22 January 2008)
Requirements for Human Blood and Blood Components Intended for Transfusion or Further Manufacturing Use: Extension of Comment Period [HTML] [PDF] (11 January 2008)
Federal Register: Direct Final Rule - Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals [HTML] [PDF] (4 December 2007)
Federal Register: Proposed Rule - Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule [HTML] [PDF] (4 December 2007)
Federal Register: Finished pharmaceuticals; manufacturing, quality control, and documentation requirements; withdrawn [HTML] [PDF] (4 December 2007)
Federal Register: Proposed Rule - Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use [HTML] [PDF] (8 November 2007)
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations [HTML] [PDF] (20 September 2007)
Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Pra ctice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Extension of Comment Period [HTML] [PDF] (17 September 2007)
Federal Register: Final Rule - Blood and blood components—Current good manufacturing practice; consignees and transfusion recipients notified of increased risk of HCV infection transmission (“lookback”) [HTML] [PDF] (24 August 2007)
Federal Register: Direct Final Rule - Biological products: Blood, blood components, and source plasma; requirements [HTML] [PDF] (16 August 2007)
Federal Register: Proposed Rule - Biological products: Blood, blood components, and source plasma; requirements [HTML] [PDF] (16 August 2007)
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations [HTML] [PDF] (9 July 2007)
FDA Publishes Final Rule Establishing Good Manufacturing Practice Regulations for Dietary Supplements [HTML] [PDF] (25 June 2007)
GMP Institute
A Division of ISPE
3109 West Dr Martin Luther King, Jr Blvd
Suite 250
Tampa, FL 33607
Phone: 813-960-2105
Fax: 813-264-2816
