FA807: cGMP of sterile dosage forms
Study Board Pharmacy
Teaching language: English, Danish or English depending on the teacher, but English if international students are enrolled
EKA: N570001122, N570001102
Assessment: Second examiner: None, Second examiner: External
Grading: Pass/Fail, 7-point grading scale
Offered in: Odense
Offered in: Autumn
Level: Master
STADS ID (UVA): N570001101
ECTS value: 5
Date of Approval:
Duration: 1 semester
Version: Archive
Comment
Entry requirements
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.
Content
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
cGMP guidelines, current Ph.Eur
See Blackboard for syllabus lists and additional literature references.
Examination regulations
Exam element a)
Timing
Autumn
Tests
Approval of 2 practical exercises
EKA
N570001122
Assessment
Second examiner: None
Grading
Pass/Fail
Identification
Full name and SDU username
Language
Normally, the same as teaching language
Examination aids
To be announced during the course
ECTS value
1
Additional information
The examination form for re-examination may be different from the exam form at the regular exam.
Exam element b)
Timing
January
Tests
Oral exam (20 minutes)
EKA
N570001102
Assessment
Second examiner: External
Grading
7-point grading scale
Identification
Student Identification Card
Language
Normally, the same as teaching language
Examination aids
To be announced during the course
ECTS value
4
Additional information
The examination form for re-examination may be different from the exam form at the regular exam.
Indicative number of lessons
Teaching Method
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).
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