Pharmaceutical Quality and Good Manufacturing Practice

MSc/ Postgraduate Certificate/ Postgraduate Diploma

This part-time course is designed to enable suitably qualified employees of the pharmaceutical industry to:

• acquire the necessary knowledge base to submit themselves for nomination as Qualified Persons (QPs)
• develop relevant academic knowledge and skills at postgraduate level
• develop research and investigative skills in the area of pharmaceutical quality and good manufacturing practice

The course is provided in a unique collaboration between the Strathclyde Institute of Pharmacy and Biomedical Sciences and NSF-DBA Ltd (formerly known as David Begg Associates (DBA)). NSF-DBA have an enviable reputation for the quality of their courses, have been providing continuing education for employees of the pharmaceutical industry for many years. Registration with NSF-DBA Ltd is required in addition to registration with the University. 

Lecturers include NSF-DBA staff, personnel from the regulatory authorities and the pharmaceutical industry, as well as University of Strathclyde staff with expertise in pharmaceutical quality.

Course Structure

Students are required to complete 6 of the NSF-DBA modules for consideration for the Postgraduate Certificate, and 12 modules for consideration for the Postgraduate Diploma. Modules run over a 21-month period as a series of thirteen one-week residential modules.

Students then complete additional study before sitting examinations for the award of the Certificate or Diploma.

The Diploma can be converted to the MSc by completion of a research project which is normally undertaken at the student's workplace.

The course is by part-time study only.

Curriculum

The course is based on the syllabus in the European-approved 'Qualified Person' (QP) study guide as used in the pharmaceutical industry.  The course content encompasses all the diverse elements required to ensure that each batch of a medicinal product meets the quality requirements of the relevant product and manufacturer's licences. This includes:

• an understanding of the pharmacology and chemistry of the product's active and other ingredients
• a knowledge of how the product was manufactured
• how the product delivers the drug in the patient's body
• how the patient's body is expected to handle the drug by way of excretion and metabolism.

Students are also made aware of the statutory framework which is applied in the control of the manufacture and distribution of medicinal products.

Course Delivery and Assessment

Each module consists of lectures, tutorials, laboratories, discussion groups and relevant visits. Modules are assessd individually. The cohesion of the student group rapidly develops as all participants are generally working in some aspect of quality assurance in the pharmaceutical industry. As such, the informal aspects of each module can become an important part of the knowledge-gathering process.

For the PGCert/PGDip and MSc, students then sit formal examinations.

For the MSc, students write and submit for examination a thesis based on their research project.

Entry requirements
Applicants should hold a relevant degree in a pharmaceutical, biological or chemical discipline or equivalent.

Students are required to have attended and completed the required number of Qualified Person (QP) or QLP modules with NSF-DBA Ltd.

Application Process

Registration with the University for the PGCert/PGDip/MSc is separate from enrollment with NSF-DBA Ltd.

Applicants should complete the University application form using the link below. Applicants are asked to upload documents including:

• Degree certificate or evidence of equivalent learning
• Evidence of English Language proficiency if English is not a first language (IELTS 6.5)

Contacts

Course Director: Dr Chris Prior
Email: c.b.prior@strath.ac.uk

Course Administrator: Catriona Howatson
Email: sipbs-pgi@strath.ac.uk

NSF-DBA Ltd Contact: The Georgian House, 22/24 West End, Kirkbymoorside, York YO62 6AF, Tel. 01751 432 999

http://www.nsf-dba.com/