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

http://busingers.ca/box-office/ Access to essential quality medicines is not a given in many sub-Saharan African countries and several other regions in the world, says WHO. Largely due to resource constraints and lack of skilled personnel, low-income countries experience poor availability of essential medicines in health facilities, substandard quality treatments, frequent stock-outs and sub-optimal prescription and use of medicines. 

At i+solutions, we have highly skilled and experienced personnel and we have built an ISO 9001:2015-certified Quality Management System, in line with WHO’s Model Quality Assurance System for Procurement Agencies (MQAS) i+ solutions holds an European Pharmaceutical Distribution License given by Dutch Health Authorities.

Our international Quality team ensures that our products are manufactured, stored and transported according to current global quality standards and WHO recommendations.

 

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

Upper Saint Clair       

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.

Victoria Garcia

Quality Assurance Manager

Tanja Porre

Quality Assurance specialist

Rutger-Jan Rietman

Head of Quality Management

Federica Cecco

Quality Assurance Specialist