The complexity of packaging materials and the highly technological nature of medicinal products is such that manufacturers are confronted with significant problems. Interaction between packaging and
such products is possible due to the combination of a multiplicity of container components and active pharmaceutical ingredients, excipients and solvents used in a variety of dosage forms.
The quality of the packaging of pharmaceutical products plays a very important role in the quality of such products. It must:
— protect against all adverse external influences that can alter the properties of the product, e.g. moisture, light, oxygen and temperature variations;
— protect against biological contamination;
— protect against physical damage;
— carry the correct information and identification of the product.
The kind of packaging and the materials used must be chosen in such a way that:
— the packaging itself does not have an adverse effect on the product (e.g. through chemical reactions, leaching of packaging materials or absorption);
— the product does not have an adverse effect on the packaging, changing its properties or affecting its protective function.
The resulting requirements must be met throughout the whole of the intended shelf-life of the product.
Continue at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/GuidelinesPackagingPharmaceuticalProductsTRS902Annex9.pdf
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