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Safe drugs, the importance of pharmaceutical packaging

Pharmaceutical legislation ensures the quality and safety of medicines through the compliance with regulations and strict controls on all manufacturing steps as well as on all used materials. Such regulations and controls, however, do not concern only the active substances and the manufacturing processes turning them into the medicinal product to be marketed, but also the materials used for its packaging.

The quality of the pharmaceutical packaging has in fact a primary importance, not only for the role it plays from the point of view of the product marketing: a packaging made with quality materials and according to the applicable norms ensures that the product remains intact and undamaged and that the information reported on it is clear.

The pharmaceutical packaging regulations provides for that the packaging of medicines meets specific requirements.

Primary packaging

Primary packaging, that is the packaging that comes into direct contact with the drug, should perfectly adapt to it, preventing the contamination by outer agents and not presenting any features that could alter it in any way. It should also be able to resist effectively to outer environment conditions, protecting the medicinal product from light and air. Finally, it should ensure an appropriate protection for the product, when moved, for instance inside the pharmacy or at home.

Secondary packaging

On the other hand, the function of the secondary packaging is different. In most cases, this is a cardboard carton, that can contain primary packages of different nature, such as blisters, vials, bottles, sachets, etc. This packaging also has a further protective function from outer agents and from environmental conditions and during transportation.

However, the main function of secondary packaging is to include information on the product. If, on one hand, the primary packaging can only include essential data about the drug (name, active substance, strength, expiry date, batch number), the secondary packaging can include more information, such as the MA holder, the known excipients and safety warnings, if required.

However, the most important function of secondary packaging is communication: the creation of the pharmaceutical packaging should therefore consider that secondary packaging represents the first impact of the user with the product. This should therefore be visually characterised so that the medicinal product is immediately recognisable, in spite of well-regulated graphics features.

For this reason, the availability of new types of innovative pharmaceutical packaging is nowadays very significant, such as sustainable pharmaceutical packaging obtained from biodegradable or recyclable resources.

Unfortunately, there are many variables making the drafting of medicines’ packaging difficult. The strict requirements it should comply with, such as the font size, and the need for any change – either in the graphics or content – to be preliminarily approved by the competent authority, slow down its production and limit the possibilities to circulate information more effectively.

Many pharmaceutical companies prefer to entrust specialised providers with the creation of pharmaceutical packaging. These offer services of pharmaceutical graphics along with those more strictly related to the product’s authorisation, and have appropriate tools for the preparation of the pharmaceutical packaging as well as competence on all the norms regulating this delicate aspect of the marketing of medicinal products.

Written by: Maria Pia Felici

Foto di Mizianitka da Pixabay