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Quality Systems

Intelligent Management
All the developmental activities carried out at Getz Pharma Research are managed and conducted intelligently, scientifically and methodically to offer you the best service and on time.

Our R&D operates in full compliance with cGMP guidelines.
The major activities of quality assurance include
  • Standard Operating Procedures
  • Change control, Incident, Deviation
  • Documentation
  • Internal Quality Audits (IQA)
  • cGMP training
  • Validation of equipment, analytical test methods and equipment cleaning verification
  • Licensing process for manufacturing and import of drug
  • Stability studies 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. 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, stability studies and tech transfer. All documentation related to the quality system to be used within the R&D premises are controlled to ensure that it is issued to the appropriate personnel, under the correct level of authority, is revised and reissued as necessary.
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