Large-scale qualification and validation in a GMP environment
Equipment commissioning & startup
Documentation, training, and operational handover
Context and key issues
As part of its R&D transformation strategy, Sanofi initiated the construction of the XL building to consolidate the Marcy and Neuville teams and to pool GMP and non-GMP activities. We are supporting the qualification of transferred equipment, as well as the implementation of an airborne decontamination solution (DSVA) within BSL2 and BSL3 (GAP IV) areas.
Equipment commissioning and startup
Coordination of transfers and tests (post-transfer, GMP/GRP test campaigns)
Drafting and execution of qualification protocols (IQ/OQ – DSVA) in BSL2/BSL3 environments
Drafting of commissioning, qualification, and regulatory validation reports
Drafting and execution of qualification protocols (IQ/OQ) and DSVA cycle qualification
Coordination of transfers and tests / test campaigns
Drafting of DSVA procedures and operational documentation
User training and operational handover of equipment
Handover of all transferred equipment after complete qualification and approval of associated reports.
DSVA equipment qualified and compliant with regulatory requirements.
DSVA cycles validated and usable in routine operations based on approved protocols and reports.
DSVA documentation (procedures and operational instructions) validated and defensible during inspections.
Internal and external users trained, qualified, and authorized to operate the DSVA system.
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