Guidelines on Packaging for Pharmaceutical Products | Part III

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Containment

The design of high-quality packaging must take into account both the needs of the product and of the manufacturing and distribution system.

Protection

The packaging must protect the product against all adverse external influences that may affect its quality or potency, such as:

  • light
  • moisture
  • oxygen
  • biological contamination
  • mechanical damage.

Stability

For primary packaging, it is necessary to know the possible interactions between the container and the contents. Normally, product/ component stability and compatibility are confirmed during the primary research and development stage.

  • The active pharmaceutical ingredients should remain within their specification limits over the shelf-life of the pharmaceutical product.
  • This can be confirmed by real-time stability studies.
  • Such studies must evaluate the changes in the quality of the product, in contact with its packaging, during a period equivalent to its intended shelf-life.

Storage

Packaging materials should be stored in accordance with GMP for storage areas. The characteristics of the active pharmaceutical ingredients will determine whether different packaging will be needed.

For example, if the contents are sterile, sterility must be maintained, including that of any unused remaining product.

The shelf life and utilization period are always determined in relation to storage conditions and the stability of the active pharmaceutical ingredient.

Compliance

Packaging and labelling may help to reinforce the instructions given by the physician or the pharmacist, and improve compliance with drug therapy.

In this respect, packaging becomes a compliance aid.The design of pharmaceutical packaging should be such that the product can easily be administered in a safe manner to the patient. If the patient feels at ease with the packaging and route of administration, the design of the packaging may become a key factor in increasing compliance. This is also an important factor in clinical trials.

Quality assurance aspects of packaging

To ensure that patients and consumers receive high-quality drugs, the quality management system must take the following considerations into account if the required quality of packaging is to be obtained:

  • the requirements of the national authorities and the relevant legislation,
  • the product,
  • the production process,
  • the manufacturers’ internal policies,

Bad packaging and packaging defects can create problems that may result in drug recalls.
Such defects may include breakage, and problems relating to printing or inks, or errors on labels and package inserts.

The use of GMP and quality control will prevent the release of a defective medicinal product.


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Reference: WHO Technical Report Series, No. 902, 2002- Annex 9


Resource Person: BARBARA PIROLA

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