FA807: cGMP of sterile dosage forms (5 ECTS)

STADS: 3854901

Level
Master's level course

Teaching period
The course is offered in the autumn semester.

Teacher responsible
Email: annette.bauer@sdu.dk

Timetable
Show entire timetable
Show personal time table for this course.

Prerequisites:
A Bachelor’s degree in pharmacy.

The course cannot be chosen by students who follow the clinical profile unless there are free places and the student follows individually approved study plan.

Academic preconditions:
Students taking the course are expected to:

• Have basic knowledge of drug dosage forms, their design, production and quality requirements
• Be able to use information given in pharmacopoeial monographs

Course introduction
The aim of the course is to enable the student to develop a general understanding of current Good Manufacturing Practice by using sterile production as an example. This is important in regard to mastering professional pharmaceutical tasks in connection to quality systems commonly employed in drug manufacturing and quality assurance of finished drug products.

The course builds on the knowledge acquired in the bachelor courses of the pharmacy program and gives an academic background for the 6 months practical period that is part of the degree.

In relation to the competence profile of the degree it is the explicit focus of the course to:

• Provide knowledge of advanced pharmaceutical forms, including knowledge of the specific advantages and disadvantages and support
• Provide competence in production, quality assurance and management of specific drugs, including advanced sterile products
• Provide skills to acquire new knowledge in an effective and independent manner and demonstrate the ability to apply this knowledge reflective and critically evaluate own and others' experiences.
• Provide skills in combining the natural science disciplines with more applied medical and pharmaceutical disciplines, specifically for the solution of pharmaceutical issues and development of new medicines targeting drug manufacture and quality.
• Provide skills in a critical and discuss complex professional and scientific problems in the pharmaceutical field
• Give knowledge and understanding of the regulatory framework in place for manufacturing and quality assurance of finished drug products

Expected learning outcome
To achieve the course's purpose it is the learning objective of the course, that the student must demonstrate the ability to:

• Identify and explain the relevant regulations
• Define quality
• Separate the quality system for aseptic production of quality system for terminally sterilised products
• Applying experience from work in the clean rooms to improving standardized work instructions
• Analyze key process step with respect to weaknesses and potential for improvement
• Argue for the chosen setup of the quality system
• Transfer the reprocessed quality system (sterile pharmaceuticals production) to another type of GMP production
• Reflect on real-life examples of the failure of the quality system as documented in published regulatory responses received by pharmaceutical companies.

Subject overview
The following main topics are contained in the course:

• Guidelines & Regulations
• Risk Analysis, Quality by Design, Process Analytical Technology, Standard Operation Procedures
• Clean rooms, design, classification, specifications
• LAF- and class II safety-bench , Isolators, RABS
• Sterilisation methods, SAL, F0-concept
• Aseptic manufacturing;  sterile filtration, aseptic vs terminal sterilization
• Monitoring  (personell; environmental)
• Sterility testing, pyrogen testing
• Cytostatics; reconstitution, work safety aspects

Literature
There isn't any litterature for the course at the moment.

Website
This course uses e-learn (blackboard).

Prerequisites for participating in the exam
None

Assessment and marking:

1. Approval of 2 practical exercises (individual gowning qualification; media-fill) and an oral presentation (standard operation procedure assignment). Internal marking by teacher on a pass/fail basis.  (1 ECTS). (3854902).
2. Oral exam (20 minutes). Danish 7-mark scale, external marking. (4 ECTS). (3854912).

Expected working hours
The teaching method is based on three phase model.
Intro phase: 14 hours
Skills training phase: 26 hours, hereof:
 - Tutorials: 10 hours
 - Laboratory exercises: 16 hours

Educational activities

Educational form
The course applies an iterative approach, based on forth and back-cycles of teacher-input, individual reading, group discussion, practical lab-experience, writing, applying, refining of SOPs and their step-wise implementation within a quality system (problem-based learning).

The chosen approach and limited availability of training slots in FKF´s clean room facility requires that the whole group of students follows a coherent period of 3 weeks full time teaching / learning.

Part of the training phase is supervised project-work (individual/in groups), where the supervision hours cannot be fixed/scheduled prior to course start.

Activities during the study phase:

• Individual self-studies: reading regulatory documents e.g. ICH guidelines, in preparation for writing SOPs
• In groups gathering and assessing experience from lab-work
• in groups discussing SOPs: feed-back cycles to implement lab-experiences 
• prepare input for tutorial: finalization of SOPs and implementation within joint quality system
• Individual critical self-assessment of learning outcome and preparation for oral exam

Language
This course is taught in Danish or English, depending on the lecturer. However, if international students participate, the teaching language will always be English.

Course enrollment
See deadline of enrolment.

Tuition fees for single courses
See fees for single courses.