NHP103 - Manufacturing Methods for NHP

Outline info
Last revision date 2018-07-20 11:48:39.39
Last review date 2018-07-20 11:48:51.758

Subject Title
Manufacturing Methods for NHP

Subject Description
This course provides an overview of methods related to the production of NHP. It addresses major aspects of manufacturing such as selection and control of starting materials and excipients, composition, handling, processing, testing and equipment used as well as process validation. It also provides students with the opportunity for developing an understanding of NHP manufacturing processes in general as well as process design and controls.

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 different manufacturing processes of NHP from the marketing innovation perspective.
  2. Discuss role and selection process of medical and non-medicinal ingredients in NHP (eg.magnesium stearate, cellulose, potassium sorbate, etc.).
  3. Describe concept and purpose of dosage form design.
  4. Explain purpose and application of different manufacturing equipment.
  5. Describe concept of process qualification and validation, including cleaning validation.
  6. Demonstrate competence in process controls, production documents, standard operating procedures (SOPs).

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
NHP process development overview.
Dosage form classification: Liquid, Semisolid, Solid. Dosage form design: general formulation consideration and routes of administration
Unit 2 Active and inactive ingredients:
Selection (Good Harvesting Practice), controls, roles and application.
Unit 3 Concept of process design
Process design consideration: dosage form, marketing expectation
Pre-formulation, formulation and scale up
Process requirements: safety, environmental compliance
Unit 4 Manufacturing and safety documentation:
Master records
Batch records
Standard operating procedures (SOPs)
In-process specifications
Workplace Hazardous Materials Information System (WHMIS) – requirements and protection
Unit 5 Concept of process qualification and validation
Types of process validation: prospective, retrospective
Critical process parameters
Equipment qualification
Installation and operational qualification
Controls of process parameters
Unit 6-7 Liquid NHP:
Oral solutions, syrups, elixirs etc.
Extraction technology and equipment
Process design, controls and validation
Unit 8-9 Semisolid NHP:
Ointments, creams, gels, aerosols, spays
technology and equipment
Process design, controls and validation
Unit 10-11 Solid NHP:
Tablets, capsules
Powders and granulation technology and equipment
Compression technology and tabletting equipment
Coating technology and equipment
Direct compression (selection of right excipients) –advantages and limitations
Unit 12 Product stability
Chemical and physical factors contributing to product stability
Design and implementation of stability program
Unit 13 Control of contamination in manufacturing process:
Types and  sources of contamination: chemical, microbial, etc.
Water system and contamination control
Cleaning validation
Pest control program
Environmental testing program

Mode of Instruction
Lectures, group discussions, in-class exercised, assignments.

Prescribed Texts

Reference Material
Techceuticals:  www.techceuticals.com
Pharmaceutical Online:  www.pharmaceuticalonline.com
Colorcon:  https://www.colorcon.com
Specialty Measurements Inc. (SMI):  www.smitmc.com

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 (2) 30%
Tests (2) 20%
Presentation (1) 20%
Project (1) 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