All medicinal products need to be protected and “consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents.
The complexity of packaging materials and the highly technological nature of medicinal products is such that manufacturers are confronted with significant problems.
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;
- 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. Given the link between the quality of a pharmaceutical product and the quality of its packaging, pharmaceutical packaging materials and systems must be subject, in principle, to the same quality assurance requirements as pharmaceutical products.
The appropriate system of quality assurance for the manufacture of pharmaceutical products should therefore follow the WHO guidelines for good manufacturing practices (GMP).
The requirements to be met by pharmaceutical packaging and packaging materials as described in compendia (pharmacopoeias) and standards (e.g. those of the International Organization for Standardization (ISO)) must be considered only as general in character.
The suitability of packaging or packaging material for any particular requirements and conditions can only be ascertained through detailed packaging and stability studies on the product concerned.
Packaging in the pharmaceutical industry varies from drug to drug and normally there are three levels of packaging commonly referred to as the primary, secondary, and tertiary packaging.
- Primary packaging system is the material that first envelops the product and holds it
- Secondary packaging system is outside the primary packaging and used to group primary packages together e.g., cartons, boxes, shipping containers, injection trays, etc.
- Tertiary packaging system is used for bulk handling and shipping e.g., barrel, container, edge protectors, etc.
- Guidelines on Packaging for Pharmaceutical Products | Part II
- Guidelines on Packaging for Pharmaceutical Products | Part III
Reference: WHO Technical Report Series, No. 902, 2002- Annex 9
Resource Person: BARBARA PIROLA