ISO 15378 - Primary Packaging Materials for Medicinal Products

The ISO 15378 certification complies with ISO 9001 requirements for good manufacturing practice in the design, manufacture and control of primary packaging materials for pharmaceutical and pharmaceutical products (cellulose, polyethylene, glass).
The service includes verification and validation of the materials produced, and risk analysis to ensure the packaging safety from any microbiological, chemical or particulate contamination and to ensure the desired functionality.

Certification Procedure

Compilation of the information questionnaire
submission of the technical/economic offer which, once accepted, constitutes a service contract
audit at the company and related reporting
in the event of a successful outcome of the previous phases, certification is assessed by a technical committee
in case of successful completion of the previous phases, the certificate is delivered to the company
annual audit to maintain the certificate.

Why RINA?

RINA is accredited by ACCREDIA and ANAB for ISO 9001:2008 in the sector 38 - Health and Social Services. Our team issues numerous certifications, both in Italy and abroad, to hospital units, clinics and nursing homes, laboratories, rehabilitation services and social care.