Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water

Table 2

WHO quality requirements implemented in JuLaDQ [34].

Quality attributes		Specifications
Personnel and organization	Personnel	Qualified, trained, and experienced
	Legal basis and organization	Legal establishment and proper organizational structure
Analytical workflow	Sampling	Appropriate sampling plan and sample documentation
	Samples	Samples unique identification and integrity during transport and storage
	Test results	Appropriate monitoring and evaluation
	Test reports	Include test results, and details of sample and test conditions
	Records	Data integrity and availability
	Methods	Proper validation
	Equipment	Calibration, servicing, and maintenance
	Lab environment	Temperature and humidity monitoring and control
	Documentation control	Written standard operating procedures for each activity
	Out-of-specifications	Corrective and preventive actions
	Customers	Complaint handling
	Contracts	Supplier and subcontractor management
	Quality audits	Continuous internal and external quality audits