NHP105 - Packaging Development and Quality Compliance

Outline info
Semester
School
Last revision date 2017-05-29 00:41:15.814
Last review date 2017-07-17 00:16:34.321


Subject Title
Packaging Development and Quality Compliance

Subject Description
The course addresses different kinds of packaging Equipment and Components with a focus on primary as well as secondary container closures, and explores different materials such as glass, plastic, metal and paper, closures, liners, and rubber stoppers that are used in packaging of FNHP. Topics include testing methods, development of quality control methodology, legislative influences on packaging technology, and the role of the package in marketing.

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. Apply knowledge of packaging technology and labeling to NHP production, marketing and distribution.
  2. Examine the Fundamentals of Packaging Technology and the Packaging Supply Chain.
  3. Determine the packaging materials and containers used in development of NHP products.
  4. Choose specific packaging and the required Word Text based on printing, Marketing, government regulations and standards.
  5. Discuss and select specific Packaging machinery used in the Packaging of NHP products.
  6. Describe how to manage the Packaging Department to increase efficiency in the packaging of NHP Products.

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)
NHP 103: Manufacturing methods for NHP

Topic Outline

Unit 1 Introduction: (Team Project Introduction) (Provide ‘The Green Book’ GMP regulations to each Student on Day 1)
1.  Introductions – Ice breaker
2.  Review course outline
3.  Basics of Packaging Line history and understanding
4.  Waste Management – Green recycling benefits
5.  Recalls and Alerts - http://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3
6.  Introduction of Team Project
a.  Create Teams – exchange contact information
Unit 2 Understanding Good Manufacturing Guidelines as related to Packaging: Utilizing the Green Book, identify and Understanding specific requirements for:
1.  Buildings and Facilities
2.  Equipment
3.  Containers Closures
4.  Packaging Labelling Control
  (Note: Team Project start)
Unit 3 Packaging Lines: 
1.  Scheduling:
a.  Why Campaign?
b.  Supply Chain, movement of materials
2.  Supply Chain Basics: ‘Bottleneck’ what is the definition, how to determine.
3.  Straight line vs U Shape Line Configuration
4.  Primary and Secondary Packaging Line configurations – pros/cons
5.  Packaging Line Log books
6.  Solid vs Powder vs Liquid Dose
Units 4 - 5 Equipment and Maintenance Requirements:
1.  Equipment requirements for:
a.  Bottling Solid Dosages.
b.  Bottling Liquids
c.  Blister Packing
2.  Selection of Packaging Equipment based on requirements
3.  Vendor selection process – F.A.T.’s
4.  IQ, OQ and PQ
Basics of Pneumatics.
5.  Importance
6.  Design
7.  Contamination prevention
Maintenance Schedules:
8.  Frequency
9.  Timing of when to schedule/ conduct Maintenance
10. Documentation
Units 6 - 7 Components:
1.  Bottle types – HDPE vs Glass
2.  Cans - types
3.  Cap types – Plain, Child resistant, rubber stoppers
4.  Common types of defects to expect.
5.  Label types – 1 ply, multiple, Leaflet, Extended Content, Insert, Outsert, paper vs polymer. Drug Identification Number (DIN) vs.Natural Product Number (NPN) vs Homeopathic Medicine Number (DIN-HM) on the label
6.  Primary vs Secondary packaging components
7.  Shipper containers and Labelling requirements
Unit 8 Review – Midterm Exam – 20%
Units 1 – 7.
Unit 9 Packaging Documentation:
1.  What’s included in a Batch Record?
2.  Main component of Packaging Operations SOPs. - How to write/create
3.  Line Clearance of Area and Equipment
4.  Packaging Equipment Set up checklist
5.  Receive and verify all Components
6.  Label Control Form – reconciliation
7.  In-process Checks
8.  Line Clearance
Unit 10 Packaging in-process testing - how to and frequency:
1.  Fill Count Checks
2.  Empty bottles – empty or low/high counts
3.  Screw Caps - (missing, skewed, loose), liners, Induction Seal
4.  Desiccant - missing or broken
5.  Drug and Package defects
a.  Visually check product for defects.
6.  Labelling
a.  Crooked
b.  flagging
7.  Inserts missing, Cartons crushed/damaged
8.  Finished Product – Check each Bundle for missing Labels, Caps, etc…
Unit 11 Sanitation and Document review:
1.  Product contact vs non-product contact Equipment and Parts
2.  Full
3.  Partial
4.  Same
5.  Cleaning Solutions
Document review and release
1.  Confirm Label yield
2.  Confirm Product yield
3.  Disposal of waste
4.  Review and process Batch Record

Individual Assignment – Create Standard Operating Procedures for each of the following:
a.  A full sanitation of a Solid Dose Bottle Room/Line.
b.  A Solid Dose Bottle Packaging Line Set up Checklist.
Unit 12 Warehousing and Brand Package Marketing
1.  Shipping label requirements
2.  Skid configurations
3.  Picking and packing
4.  Customer Shelving (Dressing)
Unit 13 Measuring and Managing Packaging Department
1.  High Performance work teams
2.  Employee Behaviours
3.  Basics of Lean principals – SMED
4.  Reliability (Packaging line efficiency measurement) – highlighting Down/Wait time, efficiency Metrics and goals.
Unit 14 Final Exam -20%
All Units

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

Prescribed Texts
None

Reference Material
The Goal – Eliyahu M. Goldratt

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:  
Team Assignment/Presentation: 50%
Mid-Term Exam: 20%
Individual Assignment:  10%
Final Exam:   20%
Total 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