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ERT 421 GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING

ERT 421 GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING. Khairul Farihan Kasim Sem 1 2009/2010. Learning approach. Details of course work contribution :. List of text books.

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ERT 421 GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING

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  1. ERT 421GOOD MANUFACTURING PRACTICE FOR BIOPROCESS ENGINEERING KhairulFarihanKasim Sem 1 2009/2010

  2. Learning approach

  3. Details of course work contribution:

  4. List of text books • Bennet.B. Pharmaceutical Production: an Engineering guide., Institution of Chemical Engineers (IChemE), Warwickshire, UK, 2003 • WHO Guidelines, Quality assurance of pharmaceuticals, Good manufacturing practicesand inspection, WHO Press, World Health Organization, Geneva, Switzerland, 2007 http://www.knovel.com/web/portal/browse/display?_EXT _KNOVEL_DISPLAY_bookid=1113 http://www.who.int/medicines/areas/quality_safety/quality_assurance/ QualityAssurancePharmVol2.pdf

  5. List of references books • Nally.J.D (Ed).,Good Manufacturing Practices for Pharmaceuticals, Sixth Edition, Informa Healthcare Inc, New York, USA,2007 • Alli, I., Food, Quality Assurance, CRC PRESS, New York, 2004 • Bliesner.D.M, ESTABLISHING A CGMP LABORATORY AUDIT SYSTEM A Practical Guide, John Wiley & Sons, Inc., Hoboken, New Jersey, 2006

  6. TUTORIAL PLAN AND MINI PROJECT

  7. Important Note: Students attendance to the classes is compulsory. If, there are occasions where the students did not attend the classes without prior notice, the students can be barred from sitting for final exam.

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