NHP104 - NHP Quality Assurance

Outline info
Last revision date 2018-07-20 11:48:39.865
Last review date 2018-07-20 11:48:53.257

Subject Title
NHP Quality Assurance

Subject Description
The course is an introduction to the concept of quality assurance and compliance. It addresses principles of quality, basic statistical concepts and applications, document systems, SOPs, quality audit, validation, ISO standards, GMPs, NHP recall and complaints handling.

Credit Status
One credit toward the Fundamentals of Natural Health Products Certificate Program

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

  1. Describe a quality assurance system and apply quality assurance/control measures to NHP licensing, manufacturing and packaging in compliance with GMPs;
  2. Discuss the roles and responsibilities of quality assurance personal within the NHP industry, as well as common challenges;
  3. Describe site licensing approval requirements, including pre-market/audit preparation and post-launch maintenance;
  4. Demonstrate competence in the completion of quality assurance documentation (e.g. SOPs, Sanitation Program, Finished Product Specifications, etc.).

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.

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.


Topic Outline

Unit 1 Introduction to Good Manufacturing Practices (GMPs) for NHPs, including:
  • Discussion of the NHPD/Health Canada’s role in Site Licence review, auditing and approval.
Unit 2 Overview of GMPs pertaining to ‘Places’, including:
  • Premises;
  • Equipment
Unit 3 Overview of GMPs pertaining to ‘People’, including:
  • Personnel;
  • Quality Assurance
Unit 4 Overview of GMPs pertaining to ‘Processes’, including:
  • Sanitation Program;
  • Operations
Units 5 & 6 Overview of GMPs pertaining to ‘Products’, including:
  • Specifications;
  • Stability;
  • Samples;
  • Records;
  • Recall Reporting;
  • Sterile Products
Unit 7 Introduction to Site Licensing for NHP Manufacturers, Packagers, Labelers and/or Importers
Unit 8 How to file a paper-based NHP Site Licence, including general practices and common deficiencies
Unit 9 Introduction to SOP Writing
Unit 10 Introduction to Facility Audits, including essential tips and techniques
Unit 11  Quality Assurance Management, including total-quality management principles.
Unit 12 Material goods review, including that of labels, packaging (e.g. bottle, lid, bag, scoop, etc.), raw materials, in-process materials and finished products
Unit 13 TBD – Overview
Unit 14 Final Exam

Mode of Instruction
Lecture and discussion

Prescribed Texts

Required Supplies

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)
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 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

Grading is based on the following marking scheme:

Assignment 55%
Presentation  10%
In-Class Exercises  5%
Final Exam 30%

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.


Approved by: Denis Gravelle