- Jan 26, 2022
Guidelines for Pharmaceutical Packaging
Many people think that packagings are superfluous. However, it must be emphasized that packaging preserves the stability and quality of medicinal products and protects them against all forms of spoilage and tampering. It’s absolutely crucial for a pharmaceutical company that sells pharmaceutical products to understand the guidelines for packaging and labelling their products. World Health Organisation (WHO) reviewed various elements of the packaging of a pharmaceutical product which aims to ensure that medicines arrive safely in the hands of the patients for whom they are prescribed.
The limits of acceptability in these various respects depend, at least in part, on climatic variables. Some of the requirements that need to be considered for the right packaging:
- 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.
- Guidelines for Pharmaceutical Packaging
The packaging’s compatibility with the active medicinal ingredients is critical for sustaining the product’s integrity. It’s important to understand the potential interactions between the container and the contents when it comes to primary packaging. Stability and compatibility of products/components are usually validated during the primary research and development stage.
Hence it is important that the packaging itself should not interact with it so as to introduce unacceptable changes excluding the effect of external factors on the product. Numerous possibilities are such as:
- the release of chemicals from components of the packaging materials;
- the release of visible and/or subvisible particles;
- the absorption or adsorption of pharmaceutical components by the packaging materials; chemical reactions between the pharmaceutical product and the packaging materials;
- the degradation of packaging components in contact with the pharmaceutical products;
- the influence of the manufacturing process (e.g. sterilization) on the container.
GMP for storage spaces should be followed when storing packaging materials. If different packaging is required, it will be determined by the characteristics of the active medicinal ingredients. Medicinal medicines kept at temperatures between 2 and 8°C, for example, may have different packaging requirements than products designed for tropical countries or light-sensitive pharmaceuticals. If the contents are sterile, the sterility of the entire package, including any unused product, must be maintained. Storage circumstances and the stability of the active medicinal ingredient are always taken into account when determining the shelf-life and use time.
Conclusion
Not sure what primary packaging suits your product? Joyi Link provides free consultation and provides a wide range of packaging for various industries such as healthcare, pharmaceutical, biotechnology, nutraceuticals as well as FMCG focused. Contact us here for more info.
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