Quality Assurance

 

Quality is an integral part of Paragon’s business practices. To achieve this end, quality management systems are implemented to comply with the internal policies as well as with national and international regulations and guidelines. Our scientists, engineers, laboratory and manufacturing teams interact directly with clients to understand their specific requirements – ensuring products are manufactured to meet strict current Good Manufacturing Practice (cGMP) requirements and customer-defined specifications.

At Paragon, quality is built into all of our services to ensure that products are consistently produced and controlled according to quality standards. Our quality systems cover all aspects of manufacturing; from the starting materials, premises and equipment, and to the training of staff. Using extensive compliance and regulatory experience, Paragon Quality complies with established plans while focusing on meeting customer and regulatory requirements.

Validation

PQ
Cleaning Verification
Method Qualification

Facilities Engineering

Preventative Maintenance
Calibration

Quality Control

Environmental Monitoring
Analytical Testing (in-process/release)

Manufacturing

Equipment
Process
Batch Record Review/Release
GMP clearance and changeover

Materials Control

Quarantine
Release

Quality Assurance Systems/Programs

Change control
Document Control
Deviations/Failure Investigations
Corrective and Preventative Action (CAPA)
Internal Audits
Supplier Qualification
Quality Agreements
Training
Record Retention

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