Building the Quality System with the Facility
Raysun is developing its pharmaceutical quality system in parallel with facility and equipment design so that procedures, records and regulatory descriptions reflect the actual installed and qualified state.
Quality Policy
Raysun is committed to protecting product quality and, ultimately, patients through science-based decisions, clear accountability, reliable data and continual improvement. Quality requirements are to be defined before execution, risks are to be assessed and controlled, and systems are to be released for use only when documented evidence demonstrates readiness.
Quality-system pillars
Contamination control strategy
The site contamination control strategy will connect facility and equipment design, personnel practices, cleaning and disinfection, barrier systems, utilities, materials, environmental monitoring, aseptic process simulation and investigation systems. It will be maintained as a lifecycle document.
Quality risk management
Risk assessments will be used to support design choices, control strategies, validation priorities, supplier oversight, change control and product introduction. Risk-management records must remain traceable to decisions and follow-up actions.
Data integrity
Paper and electronic records will be governed by attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available data principles. Computerized-system controls will be proportionate to intended use and risk.
Supplier and material management
Materials, sterile ready-to-use components, primary packaging and critical service providers will be subject to defined qualification, specification, receipt, status control and change-notification requirements.
Validation lifecycle
User requirements, design qualification, factory and site acceptance testing, installation qualification, operational qualification, performance qualification and process validation will be planned as connected evidence rather than isolated exercises.
Cleaning validation for multi-product use
Product and equipment grouping, residue limits, sampling methods, analytical capability, dirty and clean hold times, campaign length and worst-case selection will be justified before shared equipment is released for multi-product operation.
Aseptic assurance
Environmental and process monitoring, personnel qualification, sterilization and depyrogenation controls, filter integrity, container-closure integrity, interventions and aseptic process simulation will be established and qualified for the applicable process.
Current status statement
The quality framework is under development. Its implementation and effectiveness will be demonstrated through approved procedures, training, qualification, validation, internal review and the applicable regulatory process. This page does not claim an existing certification or inspection history.