Table 2

Correlation between QUAMED MQAS and GDP ratings, activities and QA criteria

MQAS auditsGDP assessmentsActivitiesQuality Assurance criteria
1QA systemQA criterion A General quality assurance requirementsIt includes the essential elements required for a stringent quality management system, that is: a documentation system with standardised norms and procedures that define all activities of the QA system; human resources management; self-inspection; continuous improvement; management of corrective and preventive actions. The activity ‘computerised systems’ is also included in this

2Documentation system
3Computerised systems
4Human resources
5Self inspection
6Product QualificationQA criterion B Continuous product qualification
 It describes the capacity of the distributor to select products from manufacturers with an adequate level of compliance with Good Manufacturing Practices (taken as an indicator of the quality of the products as supplied by the manufacturer). This criterion is only used for MQAS assessments—not for GDP assessments.

7Manufacturing site assessement
8Qualification decision (qualified sources monitoring)
9Control at receptionQA criterion C Quality control (QC) and receptionIt integrates activities covering upstream quality assurance requirements, including the reception activities (eg, verification of documentation, quality checks, sampling procedures, etc), and other QC requirements (eg, risk assessment, sampling plan, management of out-of-specifications, etc).
10Quality control
11Warehouse organisationQA criterion D Storage and handling specific productsIt integrates activities required for adequate storage (eg, physical conditions, warehouse organisation, management of cold chain, stock control, etc) and the management of specific products (recalled, returned, quarantined, falsified, etc).

12Physical storage conditions
13Management of the cold chain
14Stock Control
15Handling non conformity products
16DispatchQA criterion E Dispatch and transportIt corresponds to the distribution activities downstream, including preparation of orders, dispatch and transport. This criterion did not exist as such in our previous studies, but the activities where already evaluated.
ProcurementN/ANot included
  • GDP, good distribution practices; MQAS, Model Quality Assurance System; N/A, not applicable; QA, quality assurance.