Good manufacturing practise for pharmaceuticals

Course Description

COURSE CONTENT

LECTURES:

Principles of good manufacturing practice for pharmaceuticals. Employees. Space and equipment. Documentation.

SEMINARS:

Procedures and records. Production. Quality control. Contract manufacture and contract analysis. Complaints and product recall. Self-inspection programme.

Standard Operating Procedure (SOP) for the selected manufacturing process or analytical method:

a. Writing a standard operating procedure (SOP).

b. Analysis of the compliance of the SOP with the rules of good manufacturing practice for pharmaceuticals.

Assessment of raw material suppliers according to the requirements of good manufacturing practice for pharmaceuticals:

a. Independent analysis of supplier documentation

b. Evaluation of the conducted analysis according to the rules of good manufacturing practice for pharmaceuticals.

FIELD EXERCISES:

Conducting manufacturing plant and analytical laboratory visits for students with implemented good manufacturing practice for pharmaceuticals.

Inspection:

a. Production plant inspection exercise according to the rules of good manufacturing practice for pharmaceuticals.

b. Evaluation of the performed analysis.

LEARNING OUTCOMES

• Adopt the principles of good manufacturing practice
• Design a standard operating procedure for the specific operation in the pharmaceutical manufacturing facility
• Propose corrective actions for the certain deviation detected in the production process
• Evaluate the risks of the selected production process and propose a risk assessment
• Detect non-compliance of the selected analytical procedure with the rules of good manufacturing practice
• Propose actions to harmonize the chosen production or analytical process with the rules of good manufacturing practice

Literature

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, https://ec.europa.eu/health/documents/eudralex/vol-4_hr

Quality Rules: A Short Guide to GMP (2009), John Sharp. The Pharmaceutical and Healthcare Sciences Society.

G. Jagschies, E. Lindskog, K. Lacki, P. M. Galliher (eds.) (2018) Biopharmaceutical processing: development, design, and implementation of manufacturing processes. Elsevier.

M.-K. Yeh (ed.) (2018) Biopharmaceuticals, IntechOpen, Open access peer-reviewed Edited Volume, https://www.intechopen.com/books/biopharmaceuticals

W. Jiskoot, G. F. A. Kersten, E. Mastrobattista, B. Slütter (2019) Vaccines. In: Crommelin D., Sindelar R., Meibohm B. (eds) Pharmaceutical Biotechnology. Springer, Cham, pp. 281-304. https://link.springer.com/chapter/10.1007/978-3-030-00710-2_14#citeas

Recent review and original scientific papers related to good manufacturing practise for pharmaceuticals.