Syllabus for Internship III S.Y.

2011-2012 Course Title Course Number Credit Units Pre requisite : INTERNSHIP III : INTERN III : 2 units, 4th year 1st semester : Phar 6 and Manufacturing Pharmacy internship (200 hours)

Course Description : A study and analysis on the basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the manufacturing industry. Focuses on cGMP, drug product development regulatory & registration requirements, and different unit operations & manufacture of pharmaceutical products. Students are expected to design pharmaceutical plant and product formulation in accordance with the cGMP. Major Competency : The beginning Thomasian pharmacist understands the core concepts of quality and develops skills in identifying, compounding and dispensing, manufacturing, and storing drugs and apply these concepts and skills in the preparation of drug products. General Objectives : 1. Associate the different provisions of the current Good Manufacturing Practice with the organizational set-up, equipment, facilities, and activities in a pharmaceutical manufacturing firm. 2. Establish the regulatory requirements and guidelines on labeling in accordance with BFAD Course Outline : Monthly Grading Period Specific Objectives Content UNIT I PHARMACEUTICAL MANUFACTURING State the mission vision of the company Identify the major activities in the company to carry out their mission vision Classify the company as a drug establishment Highlight the key learning of the student during the internship period Exercise no. 1 The Pharmaceutical Manufacturing company and Summary of Key Learnings and Experience Cognitive apprenticeship Product assessment 2 hours Teaching Strategies Evaluation Tool Time Allotment

Specific Objectives

Content

Teaching Strategies Metacognitive

Evaluation Tool Product assessment

Time Allotment 2 hours

Present the organizational set-up of the company Identify the gap between the organizational set-up and cGMP basic guidelines on personnel Identify the qualifications, basic functions and responsibilities of the production manager and quality manager State the training programs of the company for the personnel Describe the sanitation and hygiene program/practice of the company and compare with cGMP Illustrate the location and construction of the manufacturing building of the company Share and Learn from other interns about their observations and be able to present an appropriate lay-out of the major areas in the company Relate the location, construction, design and lay-out of the building to section 2 & 3 of the cGMP guidelines

Exercise no. 2 - The Personnel

Exercise no. 3 The Premises and Equipment

metacognitive

Product assessment/ Mastery test

4 hours

UNIT II DRUG PRODUCT Gain comprehensive understanding on the activities involved in the receipt and storage of materials Identify key activities and documents needed when receiving and storage of materials Emphasize the importance and criticality of the activities involved in receiving and storage of materials Exercise no. 4 Receipt and Storage of Materials in the Warehouse Cognitive apprenticeship Product assessment, mastery test 4 hours

Preliminary Grading Period Specific Objectives Content Teaching Strategies Simulation strategy Evaluation Tool Product assessment Time Allotment 4 hours

Present all the processing steps involved Exercise no. 5 Production in the manufacture of drug products in different dosage forms Identify the in-process quality control (IPQC) tests done when producing drug products Stress the importance of documentation in every step of the process Relate the productions steps as learned from the internship program and from previous course Phar 3 and Phar 6 Stress the importance of cGMP in assuring quality of drug products Establish the different activities in packaging of drug products Recognize the IPQC tests done when packaging drug products Ascertain the compliance of the company with cGMP requirements in packaging drug products Gain comprehensive understanding on the activities involved prior to the distribution of the drug product to the market Identify key activities and documents needed generated during finished product quarantine and delivery to the warehouse Emphasize the importance and criticality of the activities involved in finished product quarantine and delivery to the warehouse Exercise no. 6 Packaging of Drug Products

Metacognitive

Product assessment, mastery test

2 hours

Exercise no. 7- Finished Product Quarantine and Delivery to the Warehouse

Simulation strategy

Product assessment

2 hours

Specific Objectives Determine the official pharmacopoeia specifications for the microbiological and quality of pharmaceutical products Evaluate the methods of counting microorganisms in pharmaceutical products Demonstrate the procedure recommended by the official pharmacopoeia in testing specific microorganisms Classify sterility test Differentiate the official tests in detecting and measuring pyrogens

Content Exercise no. 8 Microbiological Quality of Pharmaceutical Materials

Teaching Strategies Metacognitive

Evaluation Tool Product assessment, mastery test

Time Allotment 4 hours

Final Grading Period Specific Objectives Content UNIT III REGULATORY AFFAIRS Recognize the licenses required for Exercise no. 9A - Registration of a Drug pharmaceutical manufacturing laboratory Establishment to operate Determine the step by step procedure in the application for a LTO Determine the general and additional requirements needed for the licensing of a pharmaceutical manufacturing laboratory Evaluate the existing laws which affect the operation of the pharmaceutical manufacturing laboratory Recognize manufacturers which comply with the cGMP set by the FDA Metacognitive Product assessment 2 hours Teaching Strategies Evaluation Tool Time Allotment

Specific Objectives Determine the step by step procedure in product registration application Recognize the general and additional requirements for product registration application Recognize the laws affecting the application of product registration

Content Exercise no. 9B- Registration of a Drug Product

Teaching Strategies Metacognitive

Evaluation Tool Product assessment, mastery test

Time Allotment 2 hours

UNIT IV RESEARCH AND DEVELOPMENT Determine the importance of postmarketing surveillance of pharmaceutical products Evaluate the persons qualified for the post-marketing surveillance Demonstrate the procedure in conducting post-marketing surveys Demonstrate the steps that must be done on returned drug products Identify the conditions when to salvage the returned drug products or not Determine the steps must be done on drug products that are not salvaged Demonstrate the steps that must be done on salvage drug products Classify the drug product developed by the company Identify the activities involved in drug product development Determine the documents that can be generated from the a drug product development Exercise no. 10 Post-Marketing Surveillance of Pharmaceutical Products Metacognitive Product assessment 3 hours

Exercise no. 11 Returned and Salvaged Drug Products

Peer Mediating

Product assessment

2 hours

Exercise no. 12 Drug Product Development

Interactive lecture

Product assessment, mastery test

3 hours

Course References:

Pharmaceutics: The Science of Dosage Forms Design, 2nd Edition Ansels Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th Edition The Theory and Practice of Industrial Pharmacy, 1986 Remington Pharmaceutical Sciences, 21st Edition Pharmaceutical Codex, 12th Edition United States Pharmacopoeial/National Formulary, Latest Edition FDA Current Good Manufacturing Practice Guidelines FDA Guidelines on Labeling of Drug Products and Drug Establishments
Grading System: Grading Period Monthly Preliminary Final Periodical Examination 40% 40% 30% Quizzes 30% 30% 30% Exercises (including reports) 30% 30% 30% Internship (Evaluation Grade) Total 100% 100% 100% Breakdown 33.33% 33.33% 33.33%

10%

Course Policy:

At least with an 80% attendance Passing rate: 75%

Prepared by:

Marilyn A. Ngo, M.S. Phar James N. Pasamonte, M.M. May 2011

Date:

Approved by:

Prof. Priscilla M. Torres, PhD Dean, UST Faculty of Pharmacy