AUDITS: QUAMED conducts audits of pharmaceutical suppliers (procurement agencies, distributors, wholesalers and manufacturers) with reference to the current WHO’s Good Storage and Distribution Practices (GSDP), the Model Quality Assurance System for Procurement Agencies (MQAS) and Good Manufacturing Practices (GMP).

TECHNICAL VISITS: We also conduct technical visits to pharmaceutical suppliers. Technical visits focus on checking the level of WHO GSDP/GMP compliance but cannot be considered full GSDP/GMP audit because of the shorter duration of the visit. The results of a technical visit are a support when deciding on local purchases.

LOCAL MARKET ASSESSMENTS: We often combine the audits and/or the technical visits and present them in a “Local Market Assessment” report. The added value of a LMA is that it offers a possibility to compare different  suppliers from a quality perspective, and it describes and analyses the pharmaceutical context in which the audited and visited suppliers operate.

SUPPLIERS' AUDITS: GSDP, MQAS and GMP

For detailed information on the different audits, please download the ‘technical notes’ and the ‘Frequently Asked Question (FAQ) notes’ to the right.

All our audits are based on WHO Good Manufacturing Practices (GMP), Good Storage and Distribution Practices (GSDP), and the Model Quality Assurance System for Procurement Agencies (MQAS) current standards.

The audit results are presented in a standardized way to allow easy comparison between different potential suppliers. It allows to have a quick overview of the strengths and possible risks of a supplier (wholesaler, procurement agency or manufacturer).

GSDP TECHNICAL VISITS

Technical visits focus on checking the level of WHO GSDP compliance through site/premises visit and review of the QA system and documentation.

GSDP technical visit will generate information on the elements shown in the graphic below.

Such technical visit cannot be considered as a full GSDP audit;  all the main pillars cannot be evaluated as thoroughly as during an audit because of the shorter duration of the visit. However, it will give our partners (the organisations that has requested the technical visit) sufficient information on the visited suppliers to take in to account the possible risks associated with a purchase and to make an informed decision whether or not to procure from a specific supplier. Based on the outcome of a technical visit, the customer may also decide to request for a full audit in order to confirm the decision.

 

Local Market Assessments

To support you to select the pharmaceutical suppliers (procurement agencies, distributors, wholesalers and manufacturers) in a country that offer the best guarantees, we can organise a local market assessment that includes a combination of audit and technical visits of potential pharmaceutical suppliers. You can preselect the suppliers, or we select them together.

The objective of an LMA is to give recommendations on the local procurement of medicines and other health products.

A report details the results of the evaluations and the recommendations. These recommendations are summarized in a table listing the preferred suppliers, the second choice, and the non-recommended suppliers based on the level of compliance of their practices with the WHO standards. For distributors, you will also find recommendations regarding the sources they offer.

A graphical representation helps you to compare suppliers and guide you:  their performance in terms of distribution practices on the x-axis and the quality of the sources proposed on the y-axis for each evaluated supplier.

The results of these evaluations feed into our database.

Product dossier evaluation

A Product Dossier evaluation, is an assessment of product information that is provided by a manufacturer. It’s aim is to  to seek advice on product information related to the quality, safety and efficacy of a finished pharmaceutical product.

A product dossier evaluation is always done by one of our qualified QUAMED experts.

Product Source Assessment

A Product Source Assessment is an assessment of finished pharmaceutical product sources using a variety of product information (such name of the manufacturer, address of the manufacturing site, country of production and other information). The assessment will allow us to classify the product source according to the QUAMED GMP classification of sources.

It’s objective is to establish objective information on the risks related to the purchase of particular products. This may help QUAMED members in their procurement process.

Would you like more information about audits or get a quote? Do not hesitate to contact us via the contact form.