PHA533 - Pharmaceutical Analysis - Advanced

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Last revision date Sep 24, 2018 12:47:35 AM
Last review date Dec 3, 2018 12:18:17 AM

Subject Title
Pharmaceutical Analysis - Advanced

Subject Description
This is a one semester laboratory oriented subject intended to introduce students to aspects of pharmaceutical analytical methods validation. Students are introduced to regulatory requirements and guidelines for validation as well as validation protocol/ validation SOPs and specifications for validation. Also discussed are critical analytical and processing parameters or quality attributes.

The laboratory practical focus on the following experiments:

  1. USP active pharmaceutical ingredient (API) impurities analysis using HPLC
  2. USP uniformity of dosage unit by Weight Variation using HPLC
  3. USP uniformity of dosage unit by Content Uniformity using HPLC
  4. USP residual solvent impurities analysis of drug products by Headspace-GC

Credit Status
One credit towards the Chemical Laboratory Technology (Pharmaceutical) diploma.

Prerequisite(s)
PHA 333, TAC 333, STA 453

Co-requisite(s)
PHC 533

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

  1. a) Calculate chromatographic attributes and b) Set-up and run HPLC and GC instruments to meet United States Pharmacopeia (USP) chromatographic system suitability requirements
  2. Conduct GC analyses for residual solvent impurities to meet USP Chapter <467> requirements
  3. Understand how the theory of Headspace GC is applied to enhance analyte detection and lower limits of quantitation
  4. Conduct HPLC assay and degradant impurities on drug substances, and finished products (tablets, caplets)
  5. Be familiar with ICH validations requirements for analytical methods validation; including identifying critical validation parameters
  6. Set validation specifications based on ICH, GMP guidelines
  7. Write validation protocols/SOPs based on ICH, GMP guidelines
  8. Derive pharmaceutical equations as well as calculate potency, % LC and % impurities
  9. Know how to operate the Chemstation software that controls the Agilent 1100 HPLC, 1200 HPLC, Agilent 6890 and 7890 Headspace GC for the purpose of a) Method acquisition, b) Data review, c) Sequence reprocessing and data analysis
  10. Write laboratory reports and draft responses to laboratory deficiency

Essential Employability Skills
Communicate clearly, concisely and correctly in the written, spoken and visual form that fulfils the purpose and meets the needs of the audience.

Respond to written, spoken, or visual messages in a manner that ensures effective communication.

Execute mathematical operations accurately.

Apply a systematic approach to solve problems.

Use a variety of thinking skills to anticipate and solve problems.

Locate, select, organize, and document information using appropriate technology and information systems.

Analyze, evaluate, and apply relevant information from a variety of sources.

Interact with others in groups or teams in ways that contribute to effective working relationships and the achievement of goals.

Manage the use of time and other resources to complete projects.

Take responsibility for one's own actions, decisions, and consequences.

Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecacollege.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).

Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

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 Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.