Table 1

The five quality assurance criteria grouping the 12 activities derived from the Model Quality Assurance System

Five quality assurance criteriaTwelve activities derived from the Model Quality Assurance SystemDefinition
1General quality requirements (GQR)Documentation systemGQR includes the basic elements required for the establishment of a quality assurance system which is effective in preventing mistakes.
For example: documentation system with standardised norms and procedures that define each activity of the quality assurance system, the management of human resources, and the recall and complaints handling.
Human resources
Recall and complaints handling
2Good distribution practices (GDP)Organisation of the warehouseGDP includes the process of reception, storage and distribution of medicines.
For example: it defines under what physical conditions the products must be stored (temperature, humidity…) to prevent their degradation (development of degradation products, loss of bioavailability, etc).
Physical storage conditions
Stock control
Control at reception
3Cold chain management (CCM)Management of the cold chainCCM includes all of the means used to ensure a predefined temperature (generally between +2°C and +8°C) for temperature-sensitive products as they move through the supply chain, and so to ensure their quality, efficacy and safety.
4Selection of sources (SS)Selection of the sourcesSS includes the criteria adopted to choose products from manufacturers that comply with good manufacturing practices. It is taken as an indicator of the quality assurance of the products as supplied by the manufacturers.
5Quality control (QC)Quality controlQC includes the design and implementation of a sampling plan to check the quality of supplied products, through full chemical analysis conducted at an accredited laboratory.