Table 1

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

Five quality assurance criteria		Twelve activities derived from the Model Quality Assurance System	Definition
1	General quality requirements (GQR)	Documentation system	GQR 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
		Self-inspection
2	Good distribution practices (GDP)	Organisation of the warehouse	GDP 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
		Distribution
3	Cold chain management (CCM)	Management of the cold chain	CCM 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.
4	Selection of sources (SS)	Selection of the sources	SS 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.
5	Quality control (QC)	Quality control	QC 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.