Our manufacturing plant operates in full compliance with cGMP guidelines. The major activities of quality assurance include:

• Documentation and change control
• Internal Quality Audits (IQA)
• cGMP training
• Validation of process, equipment, equipment cleaning and analytical test methods
• Stability studies and impurity profiles as per ICH guidelines

Specifically, Getz Pharma Research offers state-of-the-art cGMP stability storage and testing capabilities, standard storage conditions meeting ICH guidelines, and additional storage options at a range of other environmental conditions for specialty products or needs such as ophthalmics. Each cGMP environmental chamber operates independently, with separate temperature and, where applicable, humidity controls. All chambers are continuously monitored by a computerized monitoring system. Temperature and humidity set-point windows are ±2°C and ±5% RH, respectively, with deviations outside set-point ranges resulting in an immediate alert. Additionally, all storage chambers are supported by full generator backup in case of power failure, with a standby chamber operational and validated for multiple conditions to account for breakdown time, if needed.

At Getz Pharma Research, our comprehensive reporting and monitoring systems ensure that our clients stay in close touch with their program. Our GMP-compliant lab follows all quality systems and procedures acceptable to worldwide regulatory agencies. Our documentation records, reports and data management systems are auditable and open to client inspection. Our technology package includes the product and process development reports, method development and validations reports, and stability reports.