Abstract
For the control of the production of medicines quality requirements are essential. Quality requirements cover the quality of the preparation throughout the whole shelf life, from release until the end of the shelf life. Medicines that are produced by the industry or prepared in a pharmacy have to meet the requirements of the European Pharmacopoeia. Status, type and structure of its monographs are dealt with. This chapter explains what quality requirements are. Also the background to the general quality requirements such as identity and content are discussed.
In this chapter the following quality requirements that are specific to pharmaceutical dosage forms are described: chemical purity, average mass, average volume, average content, uniformity of mass, uniformity of content, uniformity of dosage units, microbiological purity, sterility, endotoxins, disintegration, dissolution, particle size, particulate contamination and physical parameters such as pH, relative density and osmolality.
An overview of relevant quality requirements of important pharmaceutical dosage forms in practice is given at the end of this chapter. Analysis needs analytical validation; this is generally discussed as well.
Based upon the chapter Kwaliteitseisen by Oscar Smeets and Rik Wagenaar in the 2009 edition of Recepteerkunde.
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Notes
- 1.
This section was contributed by Herman Woerdenbag, Groningen, The Netherlands
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Smeets, O., Santillo, M., van Rooij, H. (2015). Quality Requirements and Analysis. In: Bouwman-Boer, Y., Fenton-May, V., Le Brun, P. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-319-15814-3_32
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