Pharmaceutical legislation guarantees the quality and safety of medicines through compliance with regulations and strict controls on all stages of production and all materials used.

These regulations and controls, however, do not only concern the active substances and the production processes that transform them into the medicine to be placed on the market, but also the materials used for its packaging.

Indeed, the quality of pharmaceutical packaging is of paramount importance, not only for the role it plays in the marketing of the product. But also with regard to the packaging, which has to be made with quality materials and according to applicable standards, ensuring the integrity of the medicinal product and the clarity of the information on it.

Let’s find out together specifically what requirements pharmaceutical packaging must have.

  • The packaging must not alter the drug or contaminate it
  • The packaging must be able to protect the contents
  • The packaging must be strong enough not to be manipulated
  • The packaging must allow easy access to the contents, even for people with difficulties

The following requirements apply to all types of packaging, so both blister packs and bottles or ampoules.

ISO 15378:2018 identifies the principles of Good Manufacturing Practice (GMP) and specifies the requirements for a quality management system applicable to primary packaging materials for medicinal products.

The implementation of GMP principles in the production and control of primary packaging materials is of great importance for the safety of a patient using the medicine, due to their direct contact with the product. The application of GMP for pharmaceutical packaging allows us to ensure that these materials meet the requirements of the pharmaceutical industry.

At Maca, we offer all the care and safety that the industry requires, such as communicating the contents of the packaging and including product and traceability information.


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