A Syllabus for the Proposed Pharmacy Curriculum SY 2005-2006
Course Title : Research and Thesis Writing 1 & 2
Course Number :
Credit Units : 1st Semester - Research & Thesis Writing 1: 3 units (1units lecture, 2 unit laboratory)2nd Semester - Research & Thesis Writing 2: 2 units (1units laboratory)
Course Description : This course deals with the specific problem related to pharmaceutical sciences that would be worthwhile to investigate during the laboratory work. It will comprise actual pharmaceutical and pharmacologic principles and animal testing which will be conducted inside the laboratory. It also includes the thesis writing after experimental results are completed.
Prerequisite(s) : Senior standing
General Objectives : At the end of the course, the students should be able to:
1. Relate the purpose(s) of choosing the problem for search.
2. Discuss the steps of the procedure for the investigation.
3. Present, organize, analyze and interpret the data collected and write scientifically.
4. Begin an independent study using logical thinking and scientific methods.
5. Gather new knowledge or data from primary or first-hand sources and not merely restate or reorganize what is already known or has been written.
6. Perform successfully the experimental procedures in the laboratory portion of the subject.
7. Present and defend a written output of the research.
Course Outline :
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
First Semester
1. Recall the principles of research methods and thesis writing.
2. Propose a research problem
Unit 1 – Introduction to Research and Thesis Writing
A. Orientation to the course objectives and content
B. Form and Style
C. The research problem Laboratory
a. Research and referencing 10 hrs + 6 hrs lab Individual or group research on problems/topics chosen as reported in class Quality of topic chosen and reporting in class Submission of research proposal reports
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
1. To involve students in extensive literature survey using local and international research papers.
2. Evaluate the different types of literature needed in the study
3. Familiarize on bibliography formats and catalogue
1. Identify the different types of sampling
2. Select appropriate statistical tools and formula
3. State the different types of research methodology
4. Defend the research proposal
Second Semester
1. Perform needed experimental procedure for laboratory testing and product formulation or conduct surveys
2. Analyze, present and evaluate data obtained from the experiment, surveys and questionnaire
1. Defend the research and do the necessary corrections and recommendations
2. Submit the final manuscript
Unit 2 – Review of Related Literature
A. Types of Literature
B. Bibliography and CataloguingLaboratory
a. Research and referencing
b. Informatics
Unit 3 – Review of Basic Statistics and Research Methodology
A. Sampling
B. Statistical formulas
C. Statistical tools
D. Types of research methodology
Laboratory
a. Finalization of the research
b. Proposal defense
Unit 4 – Laboratory, Checking / Monitoring of the laboratory work until completion of the Thesis
Unit 5 - Thesis Writing and Preparation of the Final Manuscript and Oral Defense as scheduled 10 hrs + 6 hrs lab8 hrs + 21 hrs lab18 hrs + 27 hrs lab80 hrs 28 hrs Class participation in giving comments, remarks and/or suggestions on reports Lecture Power Point Presentation, Information Communication Technology (ICT)Integration Assigned readings, Class group discussions Final oral examination/defense of the thesis, submission of the bound form of the approved manuscript Written Examination and Oral defense of the research proposal.Oral defense of the thesis problem Completeness and neatness of the bound thesis submitted
References : Books on Medicinal Plants authored by E. Quisumbing, de Padua and other published new books, both local and foreign sources Philippine Formulary USP/NF, latest edition Remington’s Pharmaceutical Sciences, latest editionChemical Formulary of Formulations Pharmacognosy books and manuals Quantitative Pharmaceutical Chemistry books authored by Jenkin’s etal Pharmaceutical Dosage Forms and Drug Delivery Systems by Howard AnselBooks on Chemical Investigation of Plants, authored by L. Rosenthaler Journals and Magazines on Plants or Herbal Medicines
Tuesday, June 22, 2010
Pharm Chem 1 lec syllabus
A Course Syllabus in Pharmaceutical Chemistry 1
Course Title : Chemistry and Pharmacy of Inorganic Medicinals with Qualitative Chemistry
Course Number : Pharmaceutical Chemistry 1
Credit Units : 5 units credit (3 hours lecture, 6 hours lab / week) Third Year, First Semester
Course Description : The course covers the chemistry and pharmacy of inorganic medicinals, with emphasis on those officials in the USP and NF, their preparations, properties, tests and uses. It includes the concepts and chemical reactions related to qualitative analysis of inorganic compounds.
Prerequisite(s) : Chemistry 1 (General & Inorganic Chemistry) Pharmacy 1 (Introduction to Pharmacy)
General Objectives : At the end of the course, the students should be able to:
1. Apply the knowledge, skills, principles of inorganic chemistry to medicinal and pharmaceutical chemistry.
2. Discuss the official inorganic substances used as therapeutic and diagnostic agents.
3. Manifest an appreciation of the pharmacist’s social and professional responsibilities in maintaining or restoring the health of men and animals.4. Understand the high moral and ethical standards of the pharmacy profession.
Course Outline :
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
The students are expected to:
1. Determine the rate of reaction in terms of concentration of reactants vs time.
2. Express rate law in terms of rate constants and concentration of reactants.
3. Identify the factors that affect the rate of reactions.
4. Differentiate reversible and irreversible reactions.
5. Formulate equilibrium expressions as applied to homogeneous and heterogeneous systems
6. Solve problems involving pH, pOH and buffer solutions.
I. Kinetics and Chemical Equilibrium
1. Reaction Rates and Rate Laws
2. Collision Theory and Reaction Rates
3. Factors that Control Reaction Rate
4. Reversible Reaction and Chemical Equilibrium
5. Chemical Equilibrium Constants (Ke, Ksp, Ki)
6. Calculations involving Equilibrium Constants – pH, pOH and buffer solutions 8 hrs Class Discussion,Problem SetsBoard ,Work Recitation Report Use of Overhead Projector/Multimedia Quizzes Graded recitation
Unit Examination,Periodical Examination
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
The students are expected to:
1. Characterize elements of different groups in the periodic table.
2. Discuss and illustrate important chemical reactions.
3. Identify ions and compounds.
The students are expected to:
1. Identify the different pharmaceutical aids and necessities
2. Describe the properties of different pharmaceutical aids.
3. Discuss their importance and application to pharmaceutical preparations.
The students are expected to:
1. Differentiate the ions in intra and extra-cellular fluids.
2. Discuss the functions of these ions in maintaining physiological acid-base balance.
3. Identify commercially available preparations used for electrolyte imbalance.
The students are expected to:
1. Define the ions as essential, non-essential and trace ions.
2. Explain the importance of ions in biochemical processes in the body.
The students are expected to:1
1. Define gastrointestinal agents, acidifying agents, antacids, protectives and adsorbents and saline cathartics.
2. Illustrate the mechanism of action of gastrointestinal agents.
3. Specify gastrointestinal agents as remedies for GIT disorders.
II. Group Properties of Elements (including qualitative tests for ions)
1. Representative elements
2. Transitional elements III. Pharmaceutical Aids and Necessities1. Acids and Bases2. Buffers
3. Antioxidants
4. Waters
5. Containers
IV. Major Intra and Extra-Cellular Electrolytes
1. Major physiological ions2. Physiological acid-base balance3. Electrolytes used for:a. replacement therapyb. acid-base therapyc. combination therapyV. Essential, Non-essential and Trace Ions
1. Essential Ions
2. Non-essential ions
3. Trace ions
VI. Gastrointestinal Agents
1. Acidifying agents
2. Antacids
3. Protectives and Adsorbents
4. Saline Cathartics 8 hrs5 hrs5 hrs4 hrs5 hrs Class Discussion Problem Sets Board Work Recitation Report Use of Overhead Projector/Multimedia Quizzes Graded recitation Unit Examination Periodical Examination
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
The students are expected to:
1. Define topical agents, protective agents, antimicrobials, and astringents.
2. Categorize commercially available preparations according to types of topical agents.
3. The students are expected to:
1. Identify the components in dental products, anticaries agents, and dentrifices.
2. Discuss commercially available dental products used as anticaries agents and dentrifices.
The students are expected to:
1. Describe the mechanisms of action of the respiratory agents and anitdotes.
2. List commercially available preparations used as respiratory agents and antidotes.The students are expected to show the importance of excipients to pharmaceutical preparations.
The students are expected to:
1. Review concepts of radioactivity.
2. Explain how radiopharmaceuticals and contrast media are used as diagnostic / therapeutic agents.
VII. Topical Agents
1. Protective agents
2. Antimicrobials and astringents
VIII. Dental Products
1. Anticaries agents
2. Dentrifices
IX. Miscellaneous Pharmaceutical Agents
A. Respiratory Agents
1. Inhalants
2. Respiratory Stimulants
3. Expectorants/Emetics
B. Antidotes
X. Inorganic Pharmaceutical Excipients
1. Tableting Aids
2. Suspending Agents
XI. Radiopharmaceuticals and Contrast Media
1. Radiopharmaceuticals
2. Radiopharmaceutical preparations 3 hrs3 hrs3 hrs1 hr3 hrs Class DiscussionProblem SetsBoard WorkRecitation
Report
Use of Overhead Projector/Multimedia Quizzes
Graded recitationUnit Examination
Periodical Examination
Laboratory Equipment : Standard Chemistry Laboratory Equipment
References : Block, John H. et.al., Inorganic Medicinal and Pharmaceutical Chemistry, 1974, Philadelphia, Lea and Febiger, ix, 472 p.Cotton, Frank Albert, et.al., Basic Inorganic Chemistry, 3rd ed., 1995, New York, John Wiley and Sons, xii, 838 p.Discher, Clarence A., Modern Inorganic Pharmaceutical Chemistry, 2nd ed., 1985, Waveland, Prospect Heights, 631 p.Gennaro, Alfonso R. ed., Remington’s Pharmaceutical Sciences, 20th ed., 2000, Pennsylvania, Mack Publishing Company, xvi, 2000 p.Gould, Edwin S., Inorganic Reactions and Structure, 1995, New York, Henry Holt and Company, 470 p.Halperin, Jerome A., et.al., United States Pharmacopoeia and National Formulary, 24th rev and ed., 1995, Maryland, United States Pharmacopoeial Convention Inc., Lix, 2391 p.Katakis, Dimitris, Gilbert Gordon, Mechanisms of Inorganic Reactions, 1987, New York, John Wiley and Sons, xxiii, 384 p.Perry, Dale L., Sidney, L., Phillips, ed., Handbook of Inorganic Compounds, 1995, Florida, CRC Press, Inc., lv.
References : Solne, Taito O., Charles O. Wilson, Roger’s Inorganic Pharmaceutical Chemistry, 8th ed., 1967, Philadelphia, Lea and Febiger, x, 704 p.
Prepared by : Emilio Aguinaldo College
Course Title : Chemistry and Pharmacy of Inorganic Medicinals with Qualitative Chemistry
Course Number : Pharmaceutical Chemistry 1
Credit Units : 5 units credit (3 hours lecture, 6 hours lab / week) Third Year, First Semester
Course Description : The course covers the chemistry and pharmacy of inorganic medicinals, with emphasis on those officials in the USP and NF, their preparations, properties, tests and uses. It includes the concepts and chemical reactions related to qualitative analysis of inorganic compounds.
Prerequisite(s) : Chemistry 1 (General & Inorganic Chemistry) Pharmacy 1 (Introduction to Pharmacy)
General Objectives : At the end of the course, the students should be able to:
1. Apply the knowledge, skills, principles of inorganic chemistry to medicinal and pharmaceutical chemistry.
2. Discuss the official inorganic substances used as therapeutic and diagnostic agents.
3. Manifest an appreciation of the pharmacist’s social and professional responsibilities in maintaining or restoring the health of men and animals.4. Understand the high moral and ethical standards of the pharmacy profession.
Course Outline :
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
The students are expected to:
1. Determine the rate of reaction in terms of concentration of reactants vs time.
2. Express rate law in terms of rate constants and concentration of reactants.
3. Identify the factors that affect the rate of reactions.
4. Differentiate reversible and irreversible reactions.
5. Formulate equilibrium expressions as applied to homogeneous and heterogeneous systems
6. Solve problems involving pH, pOH and buffer solutions.
I. Kinetics and Chemical Equilibrium
1. Reaction Rates and Rate Laws
2. Collision Theory and Reaction Rates
3. Factors that Control Reaction Rate
4. Reversible Reaction and Chemical Equilibrium
5. Chemical Equilibrium Constants (Ke, Ksp, Ki)
6. Calculations involving Equilibrium Constants – pH, pOH and buffer solutions 8 hrs Class Discussion,Problem SetsBoard ,Work Recitation Report Use of Overhead Projector/Multimedia Quizzes Graded recitation
Unit Examination,Periodical Examination
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
The students are expected to:
1. Characterize elements of different groups in the periodic table.
2. Discuss and illustrate important chemical reactions.
3. Identify ions and compounds.
The students are expected to:
1. Identify the different pharmaceutical aids and necessities
2. Describe the properties of different pharmaceutical aids.
3. Discuss their importance and application to pharmaceutical preparations.
The students are expected to:
1. Differentiate the ions in intra and extra-cellular fluids.
2. Discuss the functions of these ions in maintaining physiological acid-base balance.
3. Identify commercially available preparations used for electrolyte imbalance.
The students are expected to:
1. Define the ions as essential, non-essential and trace ions.
2. Explain the importance of ions in biochemical processes in the body.
The students are expected to:1
1. Define gastrointestinal agents, acidifying agents, antacids, protectives and adsorbents and saline cathartics.
2. Illustrate the mechanism of action of gastrointestinal agents.
3. Specify gastrointestinal agents as remedies for GIT disorders.
II. Group Properties of Elements (including qualitative tests for ions)
1. Representative elements
2. Transitional elements III. Pharmaceutical Aids and Necessities1. Acids and Bases2. Buffers
3. Antioxidants
4. Waters
5. Containers
IV. Major Intra and Extra-Cellular Electrolytes
1. Major physiological ions2. Physiological acid-base balance3. Electrolytes used for:a. replacement therapyb. acid-base therapyc. combination therapyV. Essential, Non-essential and Trace Ions
1. Essential Ions
2. Non-essential ions
3. Trace ions
VI. Gastrointestinal Agents
1. Acidifying agents
2. Antacids
3. Protectives and Adsorbents
4. Saline Cathartics 8 hrs5 hrs5 hrs4 hrs5 hrs Class Discussion Problem Sets Board Work Recitation Report Use of Overhead Projector/Multimedia Quizzes Graded recitation Unit Examination Periodical Examination
Specific Objectives Topics Time Allotted Teaching Strategies Evaluation Tool
The students are expected to:
1. Define topical agents, protective agents, antimicrobials, and astringents.
2. Categorize commercially available preparations according to types of topical agents.
3. The students are expected to:
1. Identify the components in dental products, anticaries agents, and dentrifices.
2. Discuss commercially available dental products used as anticaries agents and dentrifices.
The students are expected to:
1. Describe the mechanisms of action of the respiratory agents and anitdotes.
2. List commercially available preparations used as respiratory agents and antidotes.The students are expected to show the importance of excipients to pharmaceutical preparations.
The students are expected to:
1. Review concepts of radioactivity.
2. Explain how radiopharmaceuticals and contrast media are used as diagnostic / therapeutic agents.
VII. Topical Agents
1. Protective agents
2. Antimicrobials and astringents
VIII. Dental Products
1. Anticaries agents
2. Dentrifices
IX. Miscellaneous Pharmaceutical Agents
A. Respiratory Agents
1. Inhalants
2. Respiratory Stimulants
3. Expectorants/Emetics
B. Antidotes
X. Inorganic Pharmaceutical Excipients
1. Tableting Aids
2. Suspending Agents
XI. Radiopharmaceuticals and Contrast Media
1. Radiopharmaceuticals
2. Radiopharmaceutical preparations 3 hrs3 hrs3 hrs1 hr3 hrs Class DiscussionProblem SetsBoard WorkRecitation
Report
Use of Overhead Projector/Multimedia Quizzes
Graded recitationUnit Examination
Periodical Examination
Laboratory Equipment : Standard Chemistry Laboratory Equipment
References : Block, John H. et.al., Inorganic Medicinal and Pharmaceutical Chemistry, 1974, Philadelphia, Lea and Febiger, ix, 472 p.Cotton, Frank Albert, et.al., Basic Inorganic Chemistry, 3rd ed., 1995, New York, John Wiley and Sons, xii, 838 p.Discher, Clarence A., Modern Inorganic Pharmaceutical Chemistry, 2nd ed., 1985, Waveland, Prospect Heights, 631 p.Gennaro, Alfonso R. ed., Remington’s Pharmaceutical Sciences, 20th ed., 2000, Pennsylvania, Mack Publishing Company, xvi, 2000 p.Gould, Edwin S., Inorganic Reactions and Structure, 1995, New York, Henry Holt and Company, 470 p.Halperin, Jerome A., et.al., United States Pharmacopoeia and National Formulary, 24th rev and ed., 1995, Maryland, United States Pharmacopoeial Convention Inc., Lix, 2391 p.Katakis, Dimitris, Gilbert Gordon, Mechanisms of Inorganic Reactions, 1987, New York, John Wiley and Sons, xxiii, 384 p.Perry, Dale L., Sidney, L., Phillips, ed., Handbook of Inorganic Compounds, 1995, Florida, CRC Press, Inc., lv.
References : Solne, Taito O., Charles O. Wilson, Roger’s Inorganic Pharmaceutical Chemistry, 8th ed., 1967, Philadelphia, Lea and Febiger, x, 704 p.
Prepared by : Emilio Aguinaldo College
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
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
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