CHEM ENG 4036 - Pharmaceutical Process Validation & Quality
North Terrace Campus - Semester 1 - 2015
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General Course Information
Course Details
Course Code CHEM ENG 4036 Course Pharmaceutical Process Validation & Quality Coordinating Unit School of Chemical Eng and Advanced Materials(Ina) Term Semester 1 Level Undergraduate Location/s North Terrace Campus Units 3 Contact Up to 4 hours per week Available for Study Abroad and Exchange Y Assessment assignments, project reports, final examination Course Staff
Course Coordinator: Associate Professor Jingxiu Bi
Course Timetable
The full timetable of all activities for this course can be accessed from Course Planner.
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Learning Outcomes
Course Learning Outcomes
At the completion of this course, students will be able to:
1 understand the pharmaceutical process development and production process; 2 understand the regulatory basic for process validation and outline the prospective process validation; 3 understand the process validation and quality assurance; and 4 be familiar with the good design practices for GMP (good manufacturing practice) pharmaceutical facilities. University Graduate Attributes
This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:
University Graduate Attribute Course Learning Outcome(s) Knowledge and understanding of the content and techniques of a chosen discipline at advanced levels that are internationally recognised. All The ability to locate, analyse, evaluate and synthesise information from a wide variety of sources in a planned and timely manner. All An ability to apply effective, creative and innovative solutions, both independently and cooperatively, to current and future problems. All Skills of a high order in interpersonal understanding, teamwork and communication. All A proficiency in the appropriate use of contemporary technologies. All A commitment to continuous learning and the capacity to maintain intellectual curiosity throughout life. All A commitment to the highest standards of professional endeavour and the ability to take a leadership role in the community. All An awareness of ethical, social and cultural issues within a global context and their importance in the exercise of professional skills and responsibilities. All -
Learning Resources
Recommended Resources
Reference Books
Robert A. Nash and Alfred H. Wachter, Pharmaceutical Process Validation, Marcel Dekker Inc., New York. Basel. 2003
Michael Levin, Pharmaceutical Process Scale-Up. Taylor & Francis, 2005
Andrew A. Signore, Terry Jacobs, Good Design Practices for GMP Pharmaceutical Facilities, Taylor & Francis, 2005
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Learning & Teaching Activities
Learning & Teaching Modes
No information currently available.
Workload
The information below is provided as a guide to assist students in engaging appropriately with the course requirements.
Activity Contact Hours Workload Hours Lecture 25 75 Industrial lecture 6 12 Plant Tour 4 4 Laboratory Demonstration 2 4 Tutorial 8 16 TOTAL 45 111
Learning Activities Summary
Topic 1: Introduction of Pharmaceutical processes and products
· Pharmaceuticals of small molecules drugs vs biological drugs
· Process of manufacturing small molecules and biologics.
· Development process from small molecules to medicine
Topic 2: Cell Culture Process Development
· Cell growth kinetics
· Culture medium optimization
· Batch, fed-batch and continuous production scheme
· Case study in Mab cell culture process development-Jez’s talk
Topic 3: Purification Process Development
· Basic patterns of purification
· Parameters affect the production yield in purification process and optimization
· Cost effective process development and strategies
· Facilities of Purification-Laboratory
· Demonstration in Pharm Process lab
Topic 4: Process Scale-up and Scale-down
· Cell culture Process Scale-up
· Purification Process Scale-up
Topic 5: Analytical Methods for products quality control and process optimization
· Product characterization
· Analytical methods for biologics
Topic 6: Small Molecules
· Small molecules classes
· Small molecules process development
· Scale-up issues
· Characteristics for optimal routes
· Small molecules purification and analytical methods
Topic 7: GMP and Facilities Design for Pharmaceutical Manufacturing
· Regulatory and GMP
· Steps of facilities design
· Clean room
· Plant utilities-Compressed gas, water and steam
Topic 8: Quality Assurance (QA) and quality control (QC)
· How QA, QC work
· Product release
· OOS (Out of Specification)
· Plant Tour to the GMP facility and utilities
Topic 9: Regulatory and Validation
· Regulatory steps and documents
· Drug Master Files
· Regulatory process USA vs EU vs Australia
· Role of process validation
· From validation to reduce cost
· Case study-TGA Regulating the manufactures for therapeutic goods
· Checking quality for high, medium and low risk products
· Inspection and audit
Topic 10: Stability and Packaging
· Drug products stability
· Solid dosage forms
· Level of Packages
· Packaging materials
· Supply Chain -
Assessment
The University's policy on Assessment for Coursework Programs is based on the following four principles:
- Assessment must encourage and reinforce learning.
- Assessment must enable robust and fair judgements about student performance.
- Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
- Assessment must maintain academic standards.
Assessment Summary
No information currently available.
Assessment Detail
No information currently available.
Submission
No information currently available.
Course Grading
Grades for your performance in this course will be awarded in accordance with the following scheme:
M10 (Coursework Mark Scheme) Grade Mark Description FNS Fail No Submission F 1-49 Fail P 50-64 Pass C 65-74 Credit D 75-84 Distinction HD 85-100 High Distinction CN Continuing NFE No Formal Examination RP Result Pending Further details of the grades/results can be obtained from Examinations.
Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.
Final results for this course will be made available through Access Adelaide.
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Student Feedback
The University places a high priority on approaches to learning and teaching that enhance the student experience. Feedback is sought from students in a variety of ways including on-going engagement with staff, the use of online discussion boards and the use of Student Experience of Learning and Teaching (SELT) surveys as well as GOS surveys and Program reviews.
SELTs are an important source of information to inform individual teaching practice, decisions about teaching duties, and course and program curriculum design. They enable the University to assess how effectively its learning environments and teaching practices facilitate student engagement and learning outcomes. Under the current SELT Policy (http://www.adelaide.edu.au/policies/101/) course SELTs are mandated and must be conducted at the conclusion of each term/semester/trimester for every course offering. Feedback on issues raised through course SELT surveys is made available to enrolled students through various resources (e.g. MyUni). In addition aggregated course SELT data is available.
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