PFT955 - Contamination Control in Pharmaceutical Manufac.

Outline info
Semester
School
Last revision date 2017-05-29 00:41:37.182
Last review date 2017-07-17 00:16:32.2


Subject Title
Contamination Control in Pharmaceutical Manufac.

Subject Description
This subject covers the principles of contamination control in pharmaceutical manufacturing. Topics include: basic microbiology, government regulations related to contamination control, microbial control of contamination in manufacturing, air filtration, ventilation, purification and control of water system and water testing for pharmaceutical manufacturing, production hygiene, employee health and hygiene requirements, microbiological testing of environment and interpretation of critical test results, evaluation of disinfectant and cleaning validation, self inspection and training of production employees for contamination control, preparing for government inspection for compliance related to contamination control. (Lectures only)

Credit Status
One credit in the Industrial Pharmaceutical Technology Certificate Program

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

1. Demonstrate an understanding of contamination control of pharmaceutical drug products in the manufacturing environment.

2. Interpret the relevant GMP regulations of the Food & Drugs Act (Canada) pertaining to contamination.

3. Demonstrate an understanding of water systems, air filtration systems and microbiological aspects in the manufacturing environment.

4. Describe current industry trends and compliance requirements in the control of contamination.

5. Describe how to conduct effective audit and training programs for government compliance.

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 to the subject, regulatory issues related to contamination, impact of contamination on drug products
GMP regulations guidelines
Basic microbiology and general understanding of microbial contamination in pharmaceuticals
Water system, pharmaceutical water & contamination control and validation aspects in water system
Group assignment due, design of controlled environment, clean room, zone concept,  filtration and ventilation
Environmental testing program and interpretation of microbial test results
Selection of disinfectant, cleaning program and documentation
Cleaning validation, principles, protocols and reports
Pest control programme
Auditing techniques for self-inspection and preparing for HPFBI Audit
Group assignment and presentation
Employee training programs & documentation review of the subject

Mode of Instruction
Lectures, visual presentations, discussions

Prescribed Texts
None

Reference Material
Good Manufacturing Practices For Drug Manufacturers and Importers Guidelines, online http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

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 10%
Assignment 20%
Midterm 30%
Final Exam 40%

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