PFT860 - Qualification of Pharmaceutical Processes & Equip.

Outline info
Last revision date 2017-11-21 10:50:32.953
Last review date 2017-11-21 10:50:40.362

Subject Title
Qualification of Pharmaceutical Processes & Equip.

Subject Description
Emphasis in this subject is on a theoretical overview of the principles of qualification/ validation of pharmaceutical facilities, equipment and processes, introduction to the industry to ensure product quality and integrity as well as compliance with current Good Manufacturing Processes (cGMP). (Lecture only)

Credit Status
One credit toward the Industrial Pharmaceutical Technology Certificate Program

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

1. Discuss the concepts of validation and qualification as applied to the pharmaceutical industry.

2. Interpret and use the terminology related to validation and qualification in the pharmaceutical industry.

3. Demonstrate an understanding of the requirement for and importance of validation of pharmaceutical facilities, equipment and processes.

4. Explain the elements of a validation program and the need for validation master planning.

5. Describe the documentation requirements (protocols and reports) related to validation.

6. Describe the validation of facilities and various types of equipment used in the industry.

7. Be familiar with the general template and guidelines for writing validation protocols.

8. Identify critical process and equipment parameters and develop hypothetical tests to challenge them.

9. Describe the purpose and components of a validation master plan that complies with cGMP regulations.

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
Validation Overview

Types of Process Validations: Prospective, Retrospective, Concurrent and Revalidation

Validation Approvals/ Concepts

Validation Program

Validation Lifecycle, Change Control, and Revalidation

Overview of Validation Documentation: Protocols and Reports

Overview of Validation Master Planning

Introduction to Facility Validation - HVAC Validation

Clean Steam System Validation

Compressed Air System Validation, Water System Validation

Equipment Qualification

Computer-Related System Validation

Importance of Process Validation 

Mode of Instruction
Classroom lectures, class discussions and individual or small group discussions.
In order to stimulate participants to consider more efficient ways of obtaining validation, they are encouraged to bring examples of their own experiences and issues associated with the practice of validation for discussion during the course.

Prescribed Texts
A listing of selected readings and their respective websites, if applicable shall be provided to the students.  Students are expected to download these documents from the given websites for use in the course.  Course handouts shall also be provided.

Reference Material

  • Agalbco, I.P. and  Carletion, I.J, Validation of Asephic Pharmaceutical Processes, Marcel Dekker Inc, New York, 1986.
  • Berry, I.R. and Nash, R.A., Pharmaceutical Process Validation, Second Edition, Marcel Dekker Inc, New York, 1993. ISBN: 0-8247-0838-5

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:
Assignments  30%
Mid-Term Exam 30%
Final Exam 40%

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