Pharmaceutical Packaging:

1. Definition and Purpose:

   • Pharmaceutical packaging involves the science, art, and technology of enclosing or protecting pharmaceutical products for distribution, storage, sale, and use.
   • Its primary objectives include:
     • Providing Protection: Packaging safeguards drugs from external factors such as light, moisture, and physical damage.
     • Ensuring Stability: Proper packaging maintains drug integrity and stability over time.
     • Facilitating Identification: Clear labeling helps users identify the product and its contents.
     • Enhancing Convenience: Packaging design influences ease of use and administration.
     • Complying with Regulations: Packaging must adhere to regulatory requirements.

2. Levels of Pharmaceutical Packaging:

   • Tertiary Packaging:
     • Refers to the upper levels of the packaging hierarchy.
     • Includes:
       • Logistic unit: The packaging used for transportation and storage of multiple trade items.
       • Trade item: The final packaged product intended for distribution¹.
   • Secondary Packaging:
     • Surrounds the primary container (such as a bottle or blister pack).
     • Provides additional protection and information.
   • Primary Packaging:
     • Directly holds the drug product (e.g., vials, ampoules, tubes).
     • Comes into direct contact with the drug.

3. Global Standards for Identification and Labelling:

   • Global Trade Item Number® (GTIN®): A unique identifier for products.
   • Batch/Lot Number: Identifies a specific production batch.
   • Expiration Date: Indicates product shelf life.
   • Serial Number: Unique identifier for traceability