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News about GMP/cGMP


The latest Maas & Peither newsletter "LOGFILE" has just been sent to our valued customers and subscribers.  It delivers current GMP information, comments on upcoming trends and informs you about industry & regulatory news.


PIC/S adopted the revisions of the GMP Guide PE 009-9 at the last meeting in Geneva on May 5-6. They come into force on September 1, 2009 and March 1, 2010 (capping of vials).


the International Pharmaceutical Excipients Council published recently a Questions & Answers document on Quality by Design (QbD). The paper gives a good overview about questions that could help the meet the goals in the pharmaceutical industry.


EFPIA (European Federation of Pharmaceutical Industries and Associations) published recently a interesting position paper about " GMP - Inspection of Global Pharmaceutical Supply Chains".


The PDA has announced the appointment of Richard M. Johnson as the Association’s next President, effective September 2009.


EMEA announced that EFPIA and EMEA have organized a workshop to bring together industry representatives together with European assessors and inspectors at a workshop that take place in London September 29, 2009.


FDA published in Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009, to start a new program concerning the handling of form FDA 483. The program will start September 15, 2009 and will run 18 months.


New Rules will help strengthen postmarket safety data collection


The US Food and Drug Administration is reorganizing the Office of the Commissioner (OC), according to an Aug. 18 Federal Register announcement. Being realigned are four Deputy-level offices: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).


The US Food and Drug Administration announced a new program regarding the issuance of warning letters to the pharmaceutical industry. Published in the Aug. 11 Federal Register, the program is meant to better support public health protection by establishing a timeframe for “the submission and agency review of post-inspection responses to inspectional observations” that are sent to a company via a FDA 483 form, according to the Register.


Department of Commerce (DOC) Secretary Gary Locke, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and Homeland Security (DHS) Secretary Janet Napolitano today announced new guidance for businesses to plan for and respond to the upcoming flu season.


"Ensuring Patient Safety through Supply Chain Control and GMP"
13-14 October 2009 / Berlin, Germany
Meet the Maas & Peither Team in person at this important event.



Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.


Commissioner of Food and Drugs Margaret A. Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.


Come and meet Thomas Peither, President of Maas & Peither America, Inc. in person at the 2009 PDA/FDA Joint Regulatory Conference in Washington, D.C. (September 2009).  


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