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 Form Gmp 2013-2025

Food Inspection 2013-2025 Form

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Good morning, my name is Karman Leung and I am a GMP assessor from the GMP clearance section of the Manufacturing Quality Branch and have been with the branch since February 2017. Today’s webinar is the last of the series of 3 for this year, the first webinar providing an overview of the GMP clearance current framework and future directions, the second on how to submit an effective GMP clearance application and today’s webinar will cover the common deficiencies identified with GMP clearance applications. There will be quite a lot of information to go through so I will not be going through details of all deficiencies in this webinar today. This presentation however will be uploaded onto the TGA website shortly after the completion of the webinar. Slide 3 So the GMP clearance program is to ensure overseas manufacturers comply with the principles of GMP, that is, to meet the Pharmaceutical Inspection Co-operation Scheme, also known as the PIC/s guide, for the products being supplied t

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