PFT873 - Documentations and Compliance

Outline info
Last revision date 2018-07-20 11:50:01.393
Last review date 2018-07-20 11:50:33.224

Subject Title
Documentations and Compliance

Subject Description
This subject explores the need for a proper documentation of method development, method validation and instrument calibration. This documentation must be done in compliance with principles of good manufacturing practice (GMP) and good laboratory practice. Students learn to write standard operating procedures (SOP) for the analytical instruments in order to achieve consistency. (Lecture only)

Credit Status
One credit toward the Advanced Pharmaceutical Instrumentation (HPLC) Recognition of Achievement

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

1. Describe the structure and main sections of current Good Manufacturing Practices regulations.

2. Explain the elements of technical writing and learn how technical writing must be applied within pharmaceutical/chemical industries (e.g., Standard Operation Procedure, Protocol writing).

3. Properly document method development, validation and instrument calibration, including writing protocols, raw data collection and generation of final reports.

4. Assess the key elements of compliance regulatory systems such as Out Of Specification Investigation, Deviation Investigation, Change Control and their application within pharmaceutical / chemical industries.

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 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

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
Introduction, discussion on student/teacher objectives and expectations
Review of course outline, grading structure

- Food, Drug and Cosmetic Act and its evolution
- Compliance expectations from regulatory agencies
- Concept of Good Manufacturing Practices

- Regulatory Inspections
- Types of regulatory inspections
- Case studies of non-compliance
- Documentation in the pharmaceutical industry, general principles
- Types of documentation
- Manufacturing directions
- Packaging directions
- Compliant lot numbering system
- Executed batch records
- Standard Operating Procedures
- SOP milestones
- Components of compliant SOP
- Technical writing in the Pharmaceutical Industry
- FDA and Health Canada expectations related to documentation
- Quality systems and regulatory expectations
- Quality management tools
- Premises
- Warehouse
- Manufacturing and packaging areas
- Cross-contamination within the pharmaceutical industry
- Manufacturing, packaging and laboratory equipment in a compliant pharmaceutical company
- Personnel
- Training
- Management of Change
- Deviations Management
- Compliant stability program (room temperature and accelerated stability)
- Brackeeting
- Compliant Out Of Specifications / Out Of Trend Investigations
- Compliant sample and standard management program
- Concept of raw data within the pharmaceutical industry
- Electronic records and signatures, 21 CFR Part 11

Review of the material covered during previous sessions

Mode of Instruction
A combination of teaching methods will be utilized which may include lectures, discussions, group and individual work.

Prescribed Texts

Reference Material
Method Development by HPLC; Kirkland and Snyder ISBN: 978-0471007036
Practical HPLC Methodology and Applications; Brian A. Bidlingmeyer ISBN: 978-0-471-57246-6

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 ( 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:

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 I 10%
Quiz II 10%
Homework 50%
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