Table 2.

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

MQAS audits	GDP assessments	Activities		Quality Assurance criteria
	1	QA system	QA criterion A General quality assurance requirements	It 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
	2	Documentation system
	3	Computerised systems
	4	Human resources
	5	Self inspection
	6	Product Qualification	QA 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.
	7	Manufacturing site assessement
	8	Qualification decision (qualified sources monitoring)
	9	Control at reception	QA criterion C Quality control (QC) and reception	It 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).
	10	Quality control
	11	Warehouse organisation	QA criterion D Storage and handling specific products	It 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).
	12	Physical storage conditions
	13	Management of the cold chain
	14	Stock Control
	15	Handling non conformity products
	16	Dispatch	QA criterion E Dispatch and transport	It 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.
	17	Transport
	Procurement	N/A	Not included

GDP, good distribution practices; MQAS, Model Quality Assurance System; N/A, not applicable; QA, quality assurance.