Admission requirements
Completed the first year of the master Bio-Pharmaceutical Sciences. Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report, and Oral presentation. Only available to Students of the Industrial Pharmacy specialization of the master programme Bio-Pharmaceutical Sciences. The Essay Quality Control/Quality Assurance has to be completed prior to the start.
Description
The industrial internship Quality Control/Quality Assurance aims to familiarize students with the industrial production process of medicines and quality management in an operational environment. The student develops his/her critical and independent thinking ability with regard to the industrial production process and the quality issues involved. The student becomes aware of the responsibilities and position of a Qualified Person (QP) in a (bio-)pharmaceutical company.
The industrial internship is carried out in a pharmaceutical company that produces, edits or processes medicines and will take place under the supervision of a supervisor or supervisors (QP or related position in quality control and assurance) appointed by that company and an internal staff member of the LACDR (the examiner).
The student follows the entire production chain of the relevant medicine (supply chain), from the supply of raw materials and semi-finished products to release (certification) and the delivery of the final product, and thus acquires substantive knowledge of the production processes at the relevant company. The student learns where the potentially critical actions and activities take place and discovers where the possible risk factors lie in the organization as well as the production and quality management systems. The student is trained in performing a risk analysis and has gained insight into the important role that Good Manufacturing Practices (GMPs) play in quality control.
During the internship, the student participates and immerses him/herself in:
Change management and risk-based CAPA (Corrective Actions/Preventive Actions), including scheduled changes, deviations, out of specification results (Out of Specifications/Limits/Trends).
Batch certification and release (batch record review, distribution, recalls).
And at least three of the following subjects:
Contracts with suppliers and other contract partners (Service Level Agreements (SLA) and Quality Assurance Agreements (QAA)).
Pharmaceutical descriptions and evaluations (Product Quality Reviews (PQR), Site Master Files (SMF), Drug Master Files (DMF), annual reports, Environmental Monitoring reports (EM reports), trend analyzes).
Auditing (supplier qualifications, self-inspections and resolution of audit findings).
Internal qualifications (personnel, equipment, systems, processes, facilities).
Good Distribution Practices (GDPs; establishing distribution chain, assigning and changing statuses, recalling products from the market).
The student reports their experiences in a thesis composed of 2 parts, 1) an evaluation report that deals with quality control and quality assurance in the production process and 2) a report with an overview of all internship activities and a self-reflection. After completing these components of the industrial internship, the student will give a presentation about the internship in front of an assessment committee, after which he / she will be questioned about the knowledge, skills, qualifications, independence, judgment, and sense of responsibility acquired during the Industrial Pharmacy specialization.
Course objectives
After completion of this course students will have:
The ability to identify the quality of input materials and their suppliers.
In-depth knowledge of the production processes and their critical components.
Understanding of in-process controls, release analyzes and shelf-life studies.
Experience with quality systems, documentation systems, and archiving.
Experience with dealing with planned changes, deviations, corrective measures, and risk assessments.
Written a well-structured report demonstrating a broad understanding and critical attitude towards the subject area.
Ability to defend the production process and its critical components in front of an assessment committee.
Timetable
This course is scheduled for semester 2.
Mode of instruction
Practical work, self-tuition and discussions.
Assessment method
The internship will be completed in the following way:
A report with an overview of all activities of the student during the internship and a self-reflection in which the student compares his / her strengths, weaknesses, and acquired knowledge with the desired personality attributes and knowledge level of a QP.
An evaluation report on quality control and quality assurance in the production process (this report is confidential).
An oral presentation and in-depth discussion with an assessment committee, based on which the suitability of the candidate for positions in the quality assurance of the pharmaceutical industry, with particular attention to the function of Qualified Person will be assessed.
The reports and presentation are assessed by the internship supervisor and a BPS staff member on the basis of a standard form.
The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0. The final grade should be 6.0 to successfully complete this course.
Reading list
Subject to the content of the internship.
Registration
Registration via uSis for this course is not necessary.
Contact
Coordinator of the Industrial Pharmacy specialization: Emily Ouwehand MA (email: studyadvisorBPS@lacdr.leidenuniv.nl)
Remarks
This course is only available for students of the Industrial Pharmacy specialization.
This information is without prejudice. Alterations can be made for next year.