2. Number of unit : 3 Course type : Core Prerequisite: None

3. Course synopsis This course will gives complete overview about the production facility from start of the project up to the production process and how to carry out all project steps according to the guidelines of the GMP. Topics will include the background to GMP regulations and guidelines and their relevance in the laboratory, process development and pilot plant. Beside the engineering and design aspects, the course will also covers some aspects of Validation as well as Safety, Health and Environment (SHE) including Hazard and Operability Study (HAZOP) and documentations.

4. Able to explain the concepts and requirements of GMP and Validation in bioprocess production area Able to explain the GMP requirement for primary and secondary bioprocess engineering products, together with their Safety, Health and Environment (SHE) aspects. Able to analyze the GMP requirement for Laboratory, Process Development Facilities, Pilot Manufacturing Facilities and Manufacture of food and Biopharmaceutical-products.

5. Lecture : 66% (35 hours)Tutorial : 17% (7 hours)Mini project : 17% (7 hours)

7. Mid Term Test = 10% Assignment = 15% Presentation = 5% Mini project = 20%

8. Cik Khairul Farihan Kasim (C) Mr X Lecturers

9.  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.who.int/medicines/areas/quality_safety/quality_assurance/ QualityAssurancePharmVol2.pdf http://www.knovel.com/web/portal/browse/display?_EXT _KNOVEL_DISPLAY_bookid=1113

10.  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

11. Minggu/WeekKandungan Kursus / Course Contents (Panduan/Guidelines) Pensyarah/Lecturer Week 1 GMP Basic requirements Introduce GMP concept Discuss the basic requirements of plant and equipment Cik Khairul Farihan Kasim Week 2 Validation Explain and discuss the Validation Master Planning, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Handover and Process Optimization, Performance Qualification (PQ), Process Validation (PV), Cleaning Validation, and Computer System Validation. Cik Khairul Farihan Kasim Week 3 -4 GMP for Bioprocess primary products. Explain GMP for Reaction and Key Unit Operations Discuss, illustrate GMP for Production Methods and Considerations. Justify Bulk Production Facilities requirements according to GMP. TEST 1 Cik Khairul Farihan Kasim

12. Week 5 - 6 GMP for Bioprocess Secondary Products Explain Products and Processes for Bioprocess secondary products according to GMP Discuss Principles of Layout and Building Design, The Operating Environment according to GMP Containment Issues, Packaging Operations Justify GMP for Warehousing and Materials, Handling Automated Production Systems, and Advanced Packaging Technologies Cik Khairul Farihan Kasim Mid Semester Break 17 – 23 August 2009 Week 7 – 8 Safety, Health and Environment (SHE) Explain and discuss SHE Management and Systems Approach to SHE according to the GMP requirements. Compare the Risk Assessment Bioprocess Industry SHE Hazards Safety, Health and Environment Legislation MID TERM TEST (week 8) Cik Khairul Farihan Kasim

13. Week 9 GMP for Utilities and Services Describe, discuss, compare GMP for Utility and Service System Design, Sizing of Systems for Batch Production, Solids Transfer Cleaning Systems, Effluent Treatment and Waste Minimization and General Engineering Practice Requirements. Mr X Week 10 GMP for Laboratory design Describe and discuss GMP for Laboratory design planning, Fume Cupboards Extraction Hoods, Utility Services, Fume Extraction and Air Flow Systems. Apply Safety and Containment. Mr X CUTI KHAS 21- 27 September 2009 Week 11 - 12 GMP for Process Development Facilities Explain, discuss and compare Process Development, Small- Scale Pilot Facilities, Physical Manipulation Pilot Plants, Final Formulation, Filling and Packing Pilot Plants in accordance to GMP TEST 2 Mr X Week 13 - 14 GMP and Pilot Manufacturing Facilities Evaluate validation. Discuss and demonstrate Primary and Secondary Production according to GMP, Recommend GMP for design of Facilities and Equipment, Utilities and services Mr X Week 15 Study Week 26 Oktober – 1 November 2009 - Week 16 - 18 Final Examination -

14. GroupA Week 1 Mini project briefing and title selection Week 2 T1 Week 3 Mini project Week 4 T2 Week 5 Mini project Week 6 T3 Week 7 Mini project Week 8 T4 Week 9 Mini project Week 10 T5 Week 11 Mini project Week 12 T6 Week 13 T7 Week 14 MINI PROJECT PRESENTATION

15. 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.