CHEM ENG 4036 - Pharmaceutical Process Validation & Quality

North Terrace Campus - Semester 1 - 2014

This aims of this course is to introduce the fundamental concepts of pharmaceutical manufacturing, quality control and intergraded packaging validation. The course also introduces the requirements for design of facilities, equipment and processes in the pharmaceutical and related industries

  • 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
    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.

  • 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

  • Learning & Teaching Activities
    Learning & Teaching Modes

    No information currently available.


    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:

    1. Assessment must encourage and reinforce learning.
    2. Assessment must enable robust and fair judgements about student performance.
    3. Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
    4. Assessment must maintain academic standards.

    Assessment Summary

    No information currently available.

    Assessment Detail

    No information currently available.


    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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    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 ( 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.

  • Student Support
  • Policies & Guidelines
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