Course manager

Janne Holm Anov

Semester schedule

Autumn (13-week period)

ECTS

5

Language of instruction

English

Course type

Compulsory

Qualifications

Competences corresponding to participation in the disciplines Project 1, 2, and 3 are recommended.

Objectives

To enable the student to understand or enter into the establishment/assessment of quality-assurance systems within the biotechnological industry, such as the food industry and biotechnologically based pharmaceutical production. At course completion, the student will document his/her abilities in a case report

Content

• Certification and accreditation comprising international and national accreditation and certification institutions
• Relevant legislation relative to the biotechnological production of pharmaceutical and food products
• Requirements and recommendation in respect of quality assurance in the manufacturing of pharmaceutical products (EU requirements as well as ICH guidelines)
• Identification of risk factors in connection with the production of pharmaceutical and food products– e.g. by application of HACCP, and fault tree analysis, etc.
• Definition of GMP (Good Manufacturing Practice) / PRP (Prerequisite Programs)
• Food safety and principles 
• Qualification and validation of processes
• The design, implementation and maintenance of quality-assurance systems, comprising management responsibility, organisational structure, documentation and auditing of quality-assurance systems
• Principles of cleaning pertaining to biotechnological industries
• Presentation of cases from various biotechnological production manufacturers 

Learning targets

On completion of the course, the student is expected to be able to:

Knowledge

• Explain the construction and operation of quality-assurance systems as represented in relevant cases within biotechnological production
• Explain the concepts of Accreditation and Certification as well as international and national accreditation and certification institutions

Skills

• Demonstrate knowledge of selected ISO standards and ICH guidelines as well as explain how the specified requirements, making use of case studies
• Explain regulatory matters relative to pharmaceutical production and relate legislative requirements, standards, guidelines, etc. to the manufacturing of pharmaceutical products such as they are described in established cases
• Explain regulatory matters relative to food production and relate legislative requirements, standards, guidelines, etc. to the manufacturing of food products as described in established cases
• Explain relevant GMP procedures in relation to established cases within pharmaceutical and food production, respectively

Competences

• Perform risk analysis of selected case studies within the pharmaceutical production and food production with the application of HACCP, fault tree analysis or similar methods
• Set up a plan for the design, implementation and maintenance of quality assurance systems, comprising an explanation of the management's responsibility and organisational structure

Teaching method

Seminar and group work together as well as students' and companys' case presentations

Qualifications for examination participation

• Participation in all planned company visits
• Participation in all planned teaching activities involving an external lecturer
• Submission of an individual case report

All shall be executed and submitted pursuant to guidelines set out by the course manager.

Examination and aids

Oral examination based on the case report. Duration of examination: 30 min.

Permitted aids: Case report. No access to the internet

Marking 

Internal

Grading

The 7-point grading scale