Course Plan (Syllabus): Pharmaceutical Technology I

Transcription

1 Course Plan (Syllabus): Pharmaceutical Technology I (A) Course Identification and General Information Course Number & Code PPT 437 Course Title Pharmaceutical Technology I Program (s) in which the course is offered B.Pharm.Sc. (B) Course Description This course explores the elements and implementation of Good Manufacturing Practices (GMP) regulations with emphasis on necessary practices, procedures and documentation required to achieve full compliance. The course discusses the requirements for personnel, premises, equipment and documentation. This course also outlines the principles of validation and different types of in-process controls. In addition, the course explains key issues in product storage & distribution and handling of recalls and complaints. (C) Course Objectives Credit Units Units' Type Theo. Prac. Upon successful completion of the course, the students will be able to: 1) Recognize the principles of quality management and main guidelines & requirements of GMP. 2) Identify the requirements for good documentation practice and different types of documents. 3) Explain the principles of validation as an essential part of GMP. Study level/year at which this course is offered 4) Outline different types of in-process controls in pharmaceutical production. 2 5) Recommend the use of a sampling plan in different steps of pharmaceutical manufacturing. 1 1 Language of teaching the course English 7 th Pre requisite (if any) - Co requisite (if any) Location of teaching the course -

2 (D) Course Items Distribution of Semester Weekly Plan of Course Items and Activities Theoretical Aspect : (Topics to be Covered) Order Topics List , 3 Introduction to Good Manufacturing Practice. Personnel, Organization and Training: Key personnel and individual responsibilities. Personnel Hygiene. Training. 3 4, Premises/Building and Facilities: Design, structure and layout of facility. Production area. Storage are. Quality control area. Ancillary areas. Plant services, systems and utilities. Equipment and Equipment Cleaning. Documentation and Record Keeping. Validation. a manufacturing Materials Receiving, Weighing and Dispensing. Production and In-process Control. Label Control. Line Clearance. Packaging and Storage. Recalls and Returns. Distribution Practices.

3 Application part (Tutorials): (Topics to be Covered) Order Topics List GMP design for buildings & facilities. GMP layout design. Clean room classifications. Segregation & cross contamination control. HVAC (heating, ventilation & air-conditioning) systems. Clean room environment control. Specifications and testing procedures. Specifications for finished products. Master Formulae. Packaging instructions. Batch processing records. Standard operating procedures. Sampling plans. Production and in-process control. Weighing and dispensing. Packaging/Labeling control.

4 (E) Schedule of Tasks for Students During the Semester Type of Tasks Mark Proportion of Final 1 Drills 2 Exercises & Home works Project (single\group) 5 % 4 Research 5 Essay/Report 6 Participation 7 Practical Tests 8 Oral Tests 9 Quizzes 10 Written Test (1) 11 Written Test (2) , , % 15 % 15 % 12 Final Exam (practical) Final Exam (theoretical) 17, % 40 % 14 Others

5 (F) Learning Resources Written in the following order: ( Author - Year of publication Title Edition Place of publication Publisher) 1- Required Textbook(s) ( maximum two ). 1) Joseph D. Nally, (2007), Good Manufacturing Practices for Pharmaceuticals, 6 th ed., New York, USA, Informa Healthcare. 2- Essential References. 1) Andrew A. Signore, and Terry Jacobs, (2005), Good Design Practices for GMP pharmaceutical Facilities, Boca Raton, FL, USA, Taylor & Francis. 3- Recommended Books and Reference Materials. 1) Shayne C. Gad, (2008), Pharmacutical Manufacturing Handbook: Regulations and Quality, Hoboken, NJ, USA, Willy Interscience. 4- Electronic Materials and Web Sites etc. 1) Code of Fedral Regulations (CFR) Title 21: 2) WHO Good Manufacturing Practices Guidelines: 3) electronic learning management system- Course name: PPT Other Learning Material (such N/A h as computer-based programs/cd, professional standards/ regulations).