About this Project
OBJECTIVE
CQV Cleaning Validation Project and Current Decommissioning Project
SERVICES
Corporate initiative to upgrade facility compliance level from cosmetics production to meet regulatory expectations of OTC manufacturing. PSC® initiated work with a site audit to perform a gap analysis and identify compliance deficiencies. Remediation tasks were associated with each of these findings and combined into a WBS structured by compliance streams (e.g. C/Q/V, CAPA, training). PSC® deployed a team of consultants to triage critical issues, and then validation engineers to perform cleaning validation and equipment qualification of all production equipment.
A dashboard was utilized to manage issues, track status, and communicate progress with site management. Subsequent projects included major facility renovations to resolve structural issues while maintaining ongoing GMP production. PSC® was responsible for managing the mechanical upgrade aspects of the site master plan. PSC® routinely supports facility shutdowns and equipment upgrade projects. Current responsibilities include site decommissioning.
EQUIPMENT USED
- Kaye Validator
- Additional SIM for Kaye 2000
- iRTD-400 Probe
- LTR-140 Bath
- HTR-400 Bath
- Data Loggers
- Kaye Feed Thru Device
- Pressure Transducer
- CLiMET (laser particle counter)
- Low Pressure Gas Flowmeter
- CLiMET (Microbial Sampler)
- Shortridge Air Data MultiMeter
- Druck Pressure Testing
- Gas Flowmeter
- SVMS Steam Quality
- Thermocouples
- Scissor Lift
- Specialized PPE
- Specialized Tools
PROJECT SUCCESS
Cleaning validation was completed, including manual cleaning, validated loads in qualified parts washers, and validated automated tank cleaning with qualified CIP system. Equipment qualification was completed. Remediation phase was successfully concluded on schedule and transitioned to routine quality system management with ongoing support from PSC®.
