NHP102 - Laboratory Assay Methods for NHP Formulation

Outline info
Semester
School
Last revision date 2017-05-29 00:41:25.2
Last review date 2017-07-17 00:16:34.157


Subject Title
Laboratory Assay Methods for NHP Formulation

Subject Description
In this course students learn laboratory best practices, techniques, methods, instrumentation and knowledge of Laboratory operations for analyzing NNHPs. Course entails lectures, case studies and practical laboratory analysis.

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. Identify the NNHP requirements for laboratory operations and prepare testing specifications according to NNHP guidelines using a Natural Health Product.
  2. Perform an analysis of a natural health product in order to demonstrate quality, purity, safety and efficacy of a given product to ensure it meets requirements of NNHP regulations.
  3. Explore the Methodologies and Instrumentation used in analysis of Finish Products NHPs. Physical, purity and actives meet label claims.
  4. Perform various testing methods used in analyzing NNHP: Physical testing, Identification assays, Microbiological testing while using proper techniques and following Standard Operating Procedures and Good Manufacturing Practices.
  5. Evaluate and establish routine procedures for Out Of Specification (OOS) results for the Chemistry and Microbiology Laboratories.
  6. Assess, discuss and create the testing specifications requirements of NNHP.

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

Unit 1
Introduction

General Overview of testing methods used for finished NNHP testing and Laboratory Operations.
Characterization, identification and quantification standards of NNHPs
Chemicals, processed ingredients, Extracts, Identification tests, quantity, quantification by assay
Raw Material testing, theory of ID tests, chemical tests and spectroscopic (IR or NIR) techniques used for identification, theory of limit tests according to the USP
Physical testing
Vitamins and other nutrients
are analysed by pharmacopeial methods such as USP, FCC, and AOAC using Chromatographic (HPLC. GC, GC-MS), spectroscopic or titrimetric technologies
Examples: Vitamin A, B12, C, D2-D3,K, Niacin, thiamine, pyrodixin, folic acid, MSM, cholin, inositol, lutein, 5-HTP, lycopene, ,elatonin, alpha lipoic acid, caffeine, CoQ10, biotin, glucosamine, EPA, DHA, etc.
Minerals are analysed by pharmacopeial methods such as USP, FCC, AOAC using inductively coupled plasma (ICP)/MS or atomic absorption/emission (AA/AE)/MS spectroscopy.
Examples: Calcium, phosphorus, potassium, selenium, tin, vanadium, chromium, magnesium, manganese, zinc, etc.
Microbiology tests can analyse by using USP, AOAC or BAM compendia methods.
Examples:  Total aerobic plate count,  Total yeast and mold count,  Enterobacteriaceae,  Salmonella spp,  Escherichia coli,  Staphylococcus aureus,  Pseudomonas aeruginosa
Additional test for NNHPS
- Foreign matter, Determination of acid insoluble ash, Water content, Disintegration, Dissolution, Uniformity of dosage units, gluten-free” and “sulphite free” claim testing requirement, Antimicrobial effectiveness testing
Unit 2 LAB #1
Physical testing and Identification
Unit 3 Purity standards using United States Pharmacopeia 
Microbial contaminants, Chemical contaminants, Mycotoxins, Cyanobacterial toxins, Solvent residues, Pesticide residues, Contaminants in marine oils, Antibiotic residues in bee products, Oxidative stability in oils
Unit 4 LAB #2 Gas Chromatography
Analysing Residue Solvents according to <467> chapter of current United States Pharmacopoeia/National Formulary (USP/NF)
Unit 5 Microbiology theory: Gram Negatives, Gram Positive Bacteria, Anaerobes and Probiotic cultures.
Canadian regulations (permits, laboratory Biosafety guidelines) required to import cultures for positive controls.
Establish aseptic techniques, recognize and explain the appropriate selective mediums and growth conditions for each organism.
Unit 6 LAB #3 Microbiology Testing USP <2021> and <2022>
Unit 7 Vitamins and other nutrient assays
Theory of the technology and testing techniques, System Suitability Requirements and content uniformity, assay using various instrumentation to analyse NNHP.
  • Chromatographic (HPLC. GC, GC-MS)
  • Spectroscopic or titrimetric technologies
  • Pharmacopeial methods such as USP, FCC, AOAC
Unit 8 LAB #4 HPLC Testing Lab
Vitamin B12 assay identification
Unit 9 Review the importance of dissolution testing, theory of dissolution and dissolution profiling
Unit 10 LAB # 5 Dissolution and Titration
Analyse Time Release Vitamin C analysis
Unit 11 Theory of Minerals assays
Using inductively coupled plasma (ICP)/MS or atomic absorption/emission (AA/AE)/MS spectroscopy
Pharmacopeial methods such as USP, FCC, AOAC
Unit 12 LAB # 6 ICP-MS
To quantitatively determine minerals in raw materials and finished products by ICP-MS
Examples: Vanadium, Chromium, Nickel, Selenium, Molybdenum, Tin, Magnesium, Phosphorus, Potassium, Calcium, Manganese, Iron, Copper, Zinc and Sodium.
Unit 13 Out of Specifications and how they link to Quality Assurance investigations. Laboratory’s roll in major investigations
Unit 14 Hand in Case Study / Final exam
NNHP Assessment ( Assignment)
Example: Select a current NNHP product (Vitamin, Mineral, Multi, Single, Herbal, etc. products) and from the label claim explain what would have to be analysed, testing specifications, methods, instrumentation (if required), regulations and create the entire report including the laboratory supporting documentation. Perhaps they will be able to analyse their own product during this course? (At least in one lab?)
 

Mode of Instruction
Laboratory work, in-class exercised, assignments, laboratory course

Prescribed Texts
None

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

Grading is based on the following marking scheme:
Grading:  
Practical Labs (6) 60%
Assignment (1) 20%
Final Exam 20%
  100%

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