Regulatory Readiness Built on an Accurate Site Record
Raysun's immediate regulatory objective is to support Lao GMP certification of the Vientiane facility after installation, qualification, validation and operational readiness have been completed.
The facility design and quality-system development are being aligned with applicable Lao GMP requirements, with reference to current PIC/S GMP guidance and EU GMP Annex 1 principles for sterile medicinal products. These references guide current engineering and documentation work; they do not constitute certification or approval.
Raysun is preparing a Site Master File in parallel with facility design and equipment procurement. The document will describe the site, organization, pharmaceutical quality system, facilities, utilities, equipment, materials, production, quality control, validation, contracted activities, distribution, complaints and other applicable systems based on controlled evidence. It will be updated as the project moves from design to installed and qualified state.
Regulatory workstreams
Site Master File development and lifecycle maintenance
Facility, utility and equipment description control
Validation master planning and traceability
Product- and process-specific CMC documentation support
Change control between design, installed and qualified states
Inspection-readiness planning and evidence-package management
Regulatory assessment of proposed markets and project scope
Important Regulatory Notice
Raysun Biopharma is not represented on this website as EU GMP-certified, PIC/S-certified or approved by the U.S. FDA, EMA or another foreign regulator. Any future certification, inspection or product-registration statement will be published only after verification against an official record and internal approval.