PFT911 - Pharmaceutical Quality Assurance Basics

Outline info
Semester
School
Last revision date 2017-05-29 00:41:00.435
Last review date 2017-07-17 00:16:32.53


Subject Title
Pharmaceutical Quality Assurance Basics

Subject Description
This subject focuses on the concept of quality assurance and the contributions of quality assurance in a pharmaceutical organization. It takes a snapshot examination of common quality applications, tools, processes, and systems relevant to the pharmaceutical industry. Topics covered include: foundations of quality, basic statistical concepts and applications, document systems, SOPs, quality audit, validation, ISO standards, GMPs (FDA and HPFBI), product recall and complaints handling.

Credit Status
One Credit towards the Industrial Pharmaceutical Technology Certificate Program 

Learning Outcomes
Upon successful completion of this subject the student will be able to:

  1. Explain the various roles and responsibilities associated with quality assurance in a pharmaceutical organization.
  2. Apply basic statistical tools including interpretations of control charts, histograms, and probability distributions in typical  quality assurance situations.
  3. Describe how key GMP requirements are met by quality assurance, e.g.,  validation, audit, document control, recalls and customer complaints.
  4. Compare and contrast the requirements of ISO 9001 and GMPs.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
None

Topic Outline
Introduction and Definitions

  • Discuss the historical roots of the role and responsibilities currently associated with quality assurance.
Process Control and Quality Costs
  • Describe Quality Management & Explain ‘quality costs’
Management of Equipment in a Quality System
  • Compare two methodologies employed by Quality Assurance for managing equipment in a quality system
Validation
  • Purpose of validation from the GMP regulatory perspective.
  • Classify different validation approaches permitted in the GMP regulatory environment
Introduction to SPC – SPC Tools
  • Explain, with examples, the role and purpose of 9 different statistical tools.
  • Anaylze data presented as histograms and probability distributions
Control Charts
  • Control charts, Cp and Cpk approaches to determine opportunities for process improvements
Document Systems
  • Identify GMP expectations for document systems & role of QA in establishing the document system.
SOPs
  • Describe the SOP structure commonly used in the drug industry & role of QA in preparing SOPs.
Audits and Inspections
  • Describe the approach of a typical FDA audit  & prepare an audit report for a simulated internal audit
ISO Standard & GXPs
  • Compare ISO and GMP, in terms of certification vs. licencing,
Recalls and Customer Complaints
  • Describe GMP recall requirements & standard drug industry recall procedure followed by QA

Mode of Instruction
Participative lectures involving group discussions, selective reading - handouts, assignments

Prescribed Texts
Handouts

Reference Material
Quality Control and the Pharmaceutical Industry, Edited by Murray Copper.

Application of Pharmaceutical cGMP's 1997, Barr, David, Celeste, Anthony.

Pharmaceutical Process Validation, 2nd Edition, 1993, Berry, Ira R; Nash, Robert A. ISBN: 0-8247-0838-5

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control,  4th Edition, 1997, Willig, Sidney H.; Tuckerman, Murray M.; Hitchings, William S.

Juran's Quality Control Handbook, 4th Edition, 1988, Juran, J. M.; Gryna, Frank M.

Required Supplies
None

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
OR
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


Modes of Evaluation
Assignments

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecacollege.ca

LAB COURSES
Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

Grading is based on the following marking scheme:
Quiz 1 & 2 (5% & 10% ) 15%
Assignment 1 10%
Assignment 2 10%
Midterm 25%
Final Exam 40%

NOTE:  TEST AND ASSIGNMENT DATES WILL BE CONFIRMED BY THE INSTRUCTOR

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS

Approved by: Denis Gravelle