Pharmaceutical products are the foundation of a health system


It is our mission to make sure that the products we procure are always of the highest quality

At i+solutions, quality of the medicines we procure is essential for the achievement of our ambitions. To support the objectives of our organization, we implement and maintain a Quality Management System (QMS). The QMS is based on the requirements of ISO 9001:2015, Good Distribution Practices (EU GDP and WHO GDP) and WHO’s Model Quality Assurance System For Procurement Agencies (MQAS).

The QMS is built on i+solutions’ defined processes, organization and responsibilities, in order to guide us in meeting our quality objectives. In a broader sense, it ensures that our services always meet the regulatory and customer requirements.

i+solutions’ Management, QA department and staff are responsible for quality through the QMS, seeking improvement by constant review, involving suppliers and sub-contractors.

Quality is a responsibility of every employee within the organization.


Our Quality Assurance System covers

+ Quality Manual 

+ Product and vendor qualification

+ Self-inspections and audits

+ Dossier and documentation review

+ Quality Control testing

+ Handling quality incidents and CAPAs

+ Change control 

+ Handling complaints and recalls 

+ Handling products during storage and distribution

   (Traceable in ERP system)

Certifications

     

Services We Provide

Vendor qualification

We apply stringent, risk assessment-based qualification procedures to ensure that we select high quality vendors that deliver in time and according to the required and agreed specifications.

Once qualified, the vendors are monitored and reviewed, to ensure a constant level of performance.

We choose WHO or Strong Regulatory Authority (SRA) approved manufacturing sites and apply tools, such as quality questionnaires and on-site audits, to check the quality of our suppliers.

Product qualification

Qualification of the products involves thorough documentation and dossier review by trained and experienced personnel. All products, from essential medicines to Personal Protective Equipment (PPE), undergo a comprehensive qualification process. We either supply products that have been SRA- approved or non-SRA approved but meticulously reviewed and qualified by our team, to ensure that they have been manufactured and tested according to GMP and ISO standards. Products are tested in WHO pre-qualified or SRA- inspected laboratories. We continue testing and monitoring throughout the product lifecycle (see image below).

Meet our QA team.

Tanja Porre

Quality Assurance specialist

Federica Cecco

Quality Assurance Specialist