Pharma D&S




Pil User Testing

On 23 July 2013 AIFA published a notice concerning the "Updating of information leaflets of nationally authorised medicinal products to the format provided by the Q.R.D. (Working Group on Quality Review of Documents) and the identification of the criteria for ensuring their legibility, clarity, and user-friendliness". In this notice, the Evaluation and Authorisation Office asked the MA holders of nationally authorised medicinal products to observe the provision laid down in Section V “Labelling and the product information leaflet" of Legislative Decree no. 219 dated 24 April 2006, that established that the product information leaflet must reflect the results of a legibility test.

The MA holders of nationally authorised medicinal products are obliged to conduct the legibility test by 1 July 2014.
Pharma D&S offers a range of services to support companies in complying with this specific obligation:
1) Review of the PIL to align it with the format indicated by the Q.R.D;

2) Preparation of the Artwork of the PIL by the Pharma D&S graphics department in compliance with the company's graphic specifications;

3) Bridging studies: Identification of the products on which to conduct the legibility test and drawing up of the bridging report to submit to the competent authorities.

4) Conducting of the legibility test (development of the protocol, recruiting through partnerships with various national associations, interview and drawing up of the report);

5) Specific Focused Testing on “daughter” PLs;

6) Filling out of Form 1.3.4 of the registration dossier;

7) Preparation of the regulatory dossier.

Pharmaceutical packaging

The creation of the "Artwork" of the packaging materials is a highly critical operation with serious GMP and regulatory implications.
As a rule, this activity is carried out inside the pharmaceutical company that has developed facilities and skills which, further to the evolution of specific regulations, require continuous updates.
The creation of the advertising material (visual, technical datasheets, brochures, flyers, etc..) is defined in Legislative Decree no. 219 dated 24 April 2006. This activity calls for creative and technical skills for the graphic processing and at the same time, regulatory knowledge to enable the preparation of material in accordance with the regulations.
In the light of ongoing changes in the industry, these activities are subject to reorganisations with the outsourcing of the services which do not represent the company's core business.
The consolidated experience of Pharma D&S in the GMP and regulatory sectors, plus the presence of a graphics department, make it possible for the company to become a partner of pharmaceutical companies in the preparation of the artwork and advertising material, thus meeting the needs of companies to outsource various sectors in order to cut fixed structural costs.

Pharma D&S services for pharmaceutical packaging

Pharma D&S develops artwork for packaging materials:
The activity for developing the printed material takes place according to the graphic indications defined in the “reference master drawing” the client forwards to Pharma D&S in electronic format (.pdf or a format to be decided). The tests to be inserted in the artwork are sent by the client to Pharma D&S in the final version and electronic format (.doc).
Pharma D&S uses these indications to create the artwork according to the standards and layouts provided by the client. The draft of the artwork prepared by the Pharma D&S graphic artist is checked by Pharma D&S technical personnel with degrees in pharmaceutical fields, and then forwarded to the client for approval.

Development of telematic datasheets and entering on the Farmarete:
Pharma D&S develops the telematic datasheets according to the work methods defined in the procedures, and checks the compliance of the content with respect to the sworn translation in German. All the activities are recorded in a specific register according to everything established in the technical specifications between the client and Pharma D&S. Pharma D&S is able to supply the service of entering the telematic datasheets on the Farmarete, thus saving the client all the operational activities.

Development of the sworn Italian-German/Italian-French/Italian-other language translations: Pharma D&S has the translations carries out by mother-tongue technicians with degrees and experience in the pharmaceutical sector.
Pharma D&S carries out sworn translations and provides the client with original copies of the translated and sworn documents.

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