Packaging materials play a key role in ensuring the safety, quality and efficacy of drugs throughout their shelf life. They must prevent damage and protect against light, moisture, oxidation processes and other external factors that can impair the quality of drug. At the same time, packaging materials must not interact physically or chemically with the drug in the packaging, as this could lead to a change in its quality. Primary and secondary packaging must be designed considering the route of administration of the drug.

A basic distinction is made between the following classes of packaging materials:

• Primary packaging (German: Primärpackmittel): The primary packaging material is in direct physical contact with the drug and protects it from environmental influences during handling. The type of primary packaging depends on the dosage form: Tablets, for example, are usually packed in blister packs, while creams are usually stored in tubes or jars. In some cases, the primary packaging is a special system for administering the drug, such as pre-filled syringes, which serve both as a container and are used to administer the drug.
• Secondary packaging (German: Sekundärpackmittel): The components of the secondary packaging do not come into direct contact with the drug. As a rule, labels, instructions for use and outer packaging (usually collapsible boxes) are part of the secondary packaging. The secondary packaging contains one or more units of the primary packaging and in certain cases, it may contain dosing devices such as measuring spoons.
• Tertiary packaging (German: Tertiärpackmittel): Tertiary packaging contains several units of secondary packaging and is usually required for distribution and logistics. It can refer to cardboard boxes or plastic banderoles, for example.

Packaging materials ensure that the efficacy, quality and safety of a drug are maintained throughout its entire life cycle. They serve to improve handling and protect the drug from physical (mechanical) damage and environmental influences such as light, temperature, humidity, etc.

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