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

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

Minggu/Week Kandungan Kursus / Course Contents(Panduan/Guidelines)

Pensyarah/Lecturer

Week 1 GMP Basic requirementsIntroduce 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

Week 5 - 6 GMP for Bioprocess Secondary Products Explain Products and Processes for Bioprocess secondary products according to GMPDiscuss Principles of Layout and Building Design, The Operating Environment according to GMPContainment Issues, Packaging Operations Justify GMP for Warehousing and Materials, Handling Automated Production Systems, and Advanced Packaging Technologies

Cik Khairul Farihan Kasim

Mid Semester Break17 – 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

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 KHAS21- 27 September 2009

Week 11 - 12GMP for Process Development FacilitiesExplain, discuss and compare Process Development, Small-Scale Pilot Facilities , Physical Manipulation Pilot Plants, Final Formulation, Filling and Packing Pilot Plants in accordance to GMPTEST 2

Mr X

Week 13 - 14 GMP and Pilot Manufacturing FacilitiesEvaluate 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 -

Group A

Week 1 Mini project briefing and title selection

Week 2T1

Week 3Mini project

Week 4T2

Week 5Mini project

Week 6T3

Week 7Mini project

Week 8T4

Week 9Mini project

Week 10T5

Week 11Mini project

Week 12T6

Week 13T7

Week 14MINI PROJECT PRESENTATION

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.