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PT-Guide to training-Exam

The Guide to Training/Examination in

Pharmaceutical Technology

Federation of Asian Pharmaceutical Association (FAPA) established FAPA College of Pharmacy (FAPA-CP) on  November 17, 1997 and inaugurated on May 17, 1998.    The College has the responsibility to define  training requirements for pharmacist in each field of specialization and to ensure by examination that certain standards have been attained.

 

Pharmaceutical Technology  is setting up as one field of specialization to fulfill the following objectives:

1.  To  elevate  and  enhance  the  standard  of  pharmacy  practice  in  Pharmaceutical Technology.

2.  To  develop  the  highest  scientific  and  technological  competencies  of pharmacists especially in pharmaceutical industries.

                  

Registered pharmacists  who want to admit to this Fellowship Program have to :

1.    Get the approval of  Pre-qualification for Fellow  from the Pharmaceutical Association  in his/her country.

2.    Apply for primary examination through the Executive Committee Office together with primary examination fee.

3.    Apply for training courses/programs in Pharmaceutical Technology after passing primary examination accredited by the Council.

4.    Apply for final examination through the Executive Committee Office after completion of training courses/programs together with final examination fee.

 

Candidates who have completed the prescribed period of training in approved courses/programs and who have passed the examinations (primary and final examinations) shall be accepted as Fellow of Asian College of Pharmacy (F.A.C.P.)

 

Training and Examinations

Primary Examination

Primary  examination is taken to ensure that candidate has gained the knowledge  required for basic role of pharmacist in Pharmaceutical Technology.  The emphasis is presented in three modules, each module will require 60-90 hours of self study time.  Details of each module are presented as texts written including aspect of subject and name of references to enable the candidate to understand the subject and to study at home or at work.

 

Primary examination may be taken 2 times/year, and can be valid for 4 years (passing grade is 60%).

 

Primary examination in Pharmaceutical Technology  requires knowledge in the following 3 modules (each module requires 60-90 hours of study time) :

PT 001          Quality Assurance

         PT 002          Operations Management

PT 003          Research Methodology       

 


 

Training Courses/Programs

After passing the primary examination the trainee must get into the training courses/programs required in Pharmaceutical Technology.  The training extends over two or more years depending on the specialty concerned. 

 

The trainee has to choose at least 7 modules from the followings  :

PT  101  Pre-formulation Studies

PT  102  Biopharmaceutics

PT  103  Fundamental Pharmaceutical Engineering

PT  104  Packaging Sciences

PT  105  Stability of Pharmaceuticals

PT  201  Solid Dosage Forms

PT  202  Liquid and Semi-solid Dosage Forms

PT  203  Sterile Dosage Forms

PT  204  Controlled Release Dosage Forms

PT  205  Transdermal Drug Delivery Systems

PT  206  Phytopharmaceutical Technology

PT  207  Unit Operations

PT  301  Quality Control Development

PT  302  Good Laboratory Practice

PT  303  Computer System Validation

PT  401  Regulatory Affairs

PT  402  Safety, Health and Environment

PT  403  Product Development Management

PT  404  Supply Chain Management

 

In the final year of advanced training, research work is needed to demonstrate research ability of the trainee.

 

Final Examination

The examination is taken on the completion of advanced training and research work, and is thus an “exit” examination.  Eligibility to enter the examination must be first approved by the Chairman of the Court of Examiners.  The examination is in both written and oral,  involved knowledge and professional skill taken during the basic and advanced training.

 


Quality Assurance

PT 001

Professor Sumana Khomvilai

 

Objective :

To assure that all pharmaceutical products meet the required specifications as to safety and efficacy and have the identity and strength to meet the quality and purity characteristics.

 

Module Description :

The major topics of this module to be studied are as follows:

1.    Quality assurance organization model and personnel

2.    Control of components and drug product containers and closures

3.    Production and process control

4.    Packaging and labeling control

5.    Holding and distribution

6.    Management and performance checks of equipment

7.    Validations

8.    Hygiene control

9.    Laboratory accreditation programs and good laboratory practice regulations

10. Registration and regulatory affairs

11. Records and reports

12. GMP self audit

13. Returned goods

14. Pharmaceutical technical complaints

15. Recalls

16. Drug stability and shelf-life

 

Learning Procedure :

1.    Self study from textbooks

2.    Professional practice and training in pharmaceutical industries

3.    Tutorial course offered by the Pharmaceutical Association of Thailand Under Royal Patronage

 

Suggested Readings :

1.    Good manufacturing practices for pharmaceuticals, a plan for total quality control.  Third edition.  Sidney H. Willig and James R. Stoker.

2.    Quality assurance principles for analytical laboratories.  Frederick M. Garfield.

3.    Accreditation and quality assurance in analytical chemistry.  Helmut Guenzler.

4.    Good laboratory practice.  Ludwig Huber.  Hewlett-Packard Publication Number 12-5091-6259 E.

5.    Rules and guidance for pharmaceutical manufacturers, 1993.

6.    ASEAN GMP guidelines, 1996.


Operations Management

PT 002

Professor Dr. Chomchin Chantaraskul

 

Objective :

This module aims to develop the skills and knowledge needed to take effective strategic and operational decisions covering all activities from the final stages of product development to supply to the customers.

 

Module Description :

The major topics of this module to be studied are as follows :

1.    Product Management

2.    Sales Forecasting

3.    Production Planning and Control

4.    Material Requirement Planning, Purchasing and Inventory Control

5.    Quality Control Management

6.    Maintenance and Industrial Safety

7.    Budgeting, Costing and Cost Control

8.    Productivity Improvement

9.    Human Resource Management

 

Learning Procedure :

1.    Self study through textbooks and internet

2.    Tutorial Courses

3.    Field study, seminar attending

 

Suggested Readings :

Various textbooks and journal on production/operation management

 

      


Research Methodology

PT 003

Professor Dr. Sompol  Prakongpan

 

Module Description :

This module involves the understanding of methods used in scientific research, how to design and conduct a research project.  An appreciation of the role of research in expanding the knowledge base in science. These are designed to give some direct experience with the location of relevant information sources, the evaluation of published research, and the planning of new research.

 

Although the number and precise order of steps varies from one project to another, doing research usually involves some combination of the followings :

1.  formulating a research problem(s);

2.  reviewing prior research on the question(s);

3.  identifying relevant concepts and variables and their theoretically expected relationship

4.  designing and implementing a procedure to gather data;

5.  analyzing the data; and

6.  writing up the results.

 

Completion of this module candidate should be able to :

1.  develop hypotheses and build models based on the previous literature to address research question(s);

2.  construct valid and reliable measures;

3.  design and implement fruitful research project;

4.  select the most appropriate statistical techniques to investigate the proposed research question(s);

5.  interpret results of statistical analyses;

6.  present results informatively and persuasively.

 

The major topics to be addressed in the module are :

          Ethics of Science

          Research process

          Literature search

          Literature evaluation

          Research proposal

          Research design

          Data analysis

          Biostatistics

          Scientific writing

          Scientific presentation

 

Learning Procedure :

It can be done by one or more of the following means:

1. Candidate may enroll in an equivalent course.

2. Self study through textbooks and internet.

3. Tutorial course offered by The Pharmaceutical Association of Thailand under Royal Patronage.

 


Suggested Readings :

Textbooks :

1. Ott R Lyman.  An introduction to statistical methods and data analysis.  Duxbury Press, CA 1993.

2. Martin Bland.  An Introduction to medical statistics.  Oxford Medical Publications. London, 1991.

3.  Bolton.  Pharmaceutical statistics. 2nd ed., Marcel Dekker, 1990.

4. Kerlinger, Fred N. Foundations of Behavioral Research, 3rd ed., Fort Worth: Harcourt Brace college Publishers, 1986.

Journals :

          Biological and Pharmacy Bulletin

          Chemistry and Pharmacy Bulletin

          Drug Development and Industrial Pharmacy

International Journal of Pharmaceutics

          Journal of Pharmaceutical Sciences

          Journal of Pharmacy and Pharmacology

          Pharmaceutical Research

 







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