QC 2 Syllabus

A Syllabus for the Proposed Pharmacy Curriculum for SY 2004-2005

Course Title: QUALITY CONTROL II WITH INSTRUMENTATION (Lecture)

Course Number: PHAR. CHEM. 4

Course Description: This is a continuation of Quality Control I with application of instrumental methods of analysis. It includes the principles, organization and function of quality control in the pharmaceutical and cosmetic industry. In-process test, the use of quality control charts for solid pharmaceuticals, stability testing as well as quality assurance functions in various stages of manufacture are discussed.

Prerequisite(s): PHAR CHEM 3 (QC 1), Pharmaceutics 2 (Fourth Year: First Semester)

General Objectives: At the end of the course, the students should be able to:
1. Discuss the general quality control process and validation procedures.
2. Apply the principles of instrumental methods of analysis in various pharmaceutical products.
3. Understand the application of stability tests, statistical quality control as tools for evaluating processes.
4. Interpret results obtained as to specification.
5. Show the relevance of quality assurance in various stages of manufacture.
6 Foster awareness and appreciation of the pharmacists concern in insuring product quality

First Grading Period

Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tools
At the end of the grading period, the student should be able to:
1.describe the quality control/quality assurance organizational chart, control procedures and its functions.
2.distinguish the different sampling plans applicable to pharmaceuticals and cosmetic quality control.
3.describe how material control of a product is conducted.
A. Introduction
1.Objectives of Quality Control Systems
2.Benefits derived from a Quality Control Systems
3.Quality Control Organizational Chart
B. Quality Control
1.Standards and Specifications
2.Defects and Quality Variations
3.Control Functions
4.Material Control
C. Sampling and Sampling Plans
1. Acceptance Sampling
2. Inspection Methods
3. Sampling Plans:
Square Root System and Military Standards 3 hours3 hours 3 hours Lecture,Drills,Exercises,Assignment,Seatwork,Quizzes,Monthly Examination
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tools
D. Material Control
1. Raw Material Control
2. Printed and Packaging Components
3. Labeling Control
4. Containers and Closure Control
5. Reassay 3 hours


Second Grading Period

Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tools
At the end of the grading period, the student should be able to:
1. illustrate the proper sequence of control procedures done on a product during manufacturing, packaging and distribution.
2. learn statistical quality control as a tool in monitoring quality variations.
3. prepare and analyze control charts
4. explain principles of stability studies, its vital role in the manufacture of drugs and cosmetics, its relationship in the calculation of shelf life and expiration dates.
5. discuss the principle of dissolution, its importance and application to pharmaceutical quality control.
A. Manufacturing Control1. Documentation
2. In-process Control
3. Finished Product Control (summary of control tests for various dosage forms)
B. Packaging Control
C. Distribution Control (Finished Goods/Warehouse)
D. Statistical Quality Control
1. Control Charts
2. Problem, Construction and Evaluation of Control Charts
E. Stability Studies
1. Pharmaceutical Kinetics
2. Principles and Requirements to Initiate a Stability Study
3. Physical and Chemical Stability
4. Normal Stability and Predictive Study
a. calculations, evaluation, application
b. overages
F. Dissolution Testing 3 hours2 hours1 hour4 hours5 hours Lecture Drills Exercises Assignment, Seatwork,Quizzes,Preliminary Examination


Third/ Final Grading Period

Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tools
At the end of the grading period, the student should be able to:
1. define validation, give its importance and application.
2. enumerate and contrast the different validation techniques.
3. identify the different instrumental methods, its principles and applications to pharmaceutical quality control.
A. Validation
1. Process and Assay Validation
2. Validation and Qualification of Manufacturing Equipment and Existing Products
3. Cleaning Validation
4. Post Validation
B. Instrumentation - principles, instrumentation and applications to pharmaceutical quality control
I. Spectrometry
1. X-ray Method
2. UV-Vis
3. IR
4. NMR
5. Atomic Spectrophotometry· AAS· AES
6. Emission Spectrometry· Flame Photometry (Flame Emission Spectrometry)· Fluorescence Spectrometry (Fluorometry)
7. Mass Spectrometry
8. Light Scattering Spectrometry· Turbidimetry· Nephelometry
II. Electrometric Method
1. Potentiometry
2. Voltammetry· Polarography· Amperometry
3. Coulometry 3 hours 24 hours LecturesDrills Research Work Assignment,Seatwork,Graded Recitation
Final Examination

Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tools
III. Chromatography
1. Paper
2. Column
3. TLC
4. Gas
5. HPLC IV. Radioactivity


Textbook:

Knevel, Adelbert and Frank DiGangi editors, Jenkin’s Quantitative Pharmaceutical Chemistry, 7th ed., New York, McGraw-Hill, Book Co., 1977.

Lerma, Norma V. and Osi, Marina O. Drug and Cosmetic Quality Control with Instrumentation.

References:

Evans, James Robert. The Management and Control of Quality. St. Paul: South Western, 1999

Andres, Tomas Q. How to be Globally Competitive: An ISO Guide. Giraffe Books, 1997

World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Geneva: World Health Organization, 1999

World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations: Thirty-fifth Report. Geneva: World Health Organization, 1999

Smith, Gerald M. Statistical Process Control and Quality Improvement. Upper Saddle River, NJ: Prentice Hall, 1998

USP/NF, latest edition

Remington’s Pharmaceutical Sciences, latest edition