Abstract
The quality of pharmaceutical preparations is the result of the planning and implementation of the manufacturing process. The Good Manufacturing Practice (GMP) principles and guidelines are about incorporating quality into all aspects of the manufacturing process. This chapter covers the planning, implementation, monitoring and validation of the process, as well as product quality control and release.
Preparations differ in size and complexity. The scale can range from a tailor-made preparation for one patient to production for many thousands of patients. The complexity can range from reconstitution to complex preparations from active pharmaceutical ingredients (API) and excipients. For all kind of preparations it is essential to minimise the risk of mix-up or cross-contamination by applying technical measures and an appropriate working discipline. All preparation steps must be controlled and traceable. A validated procedure for quarantine, final quality control and release has to be in place. Furthermore, to guarantee the quality and safety of a product the preparation and cleaning processes have to be validated, including the qualification of premises and equipment. These validation activities have to be planned and executed in accordance with quality risk management principles.
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Lange, R., Schnor, T. (2023). Product Quality, Quality Control and Validation. In: Le Brun, P., Crauste-Manciet, S., Krämer, I., Smith, J., Woerdenbag, H. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-031-20298-8_32
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