Manufacturing and Facility Validation Services
Whether you are building a new facility or expansion to your existing operations; installing new capital equipment; re-validating existing equipment / utilities or you have been challenged with compliance deficiencies with your manufacturing operations/equipment, facility or utility, turn to the experts at Regulatory Compliance 黄人导航庐 Inc. We can develop and tailor the appropriate cGMP validation program to help.
We perform an array of validation services, such as:
- We can assist with the entire validation life cycle continuum鈥攕tarting with the validation strategy/validation master plan through purchase, qualification, and commissioning
- We have cGMP experts that can help and guide you from design qualification, and user requirement definition through factory/site acceptance and through commissioning and qualification. We have experts in user requirement specification (URS), drug specification (DS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification/process qualification (IQ/OQ/PQ) summary reports
- Expertise in the validation of: equipment, facilities, utilities, computer systems, and controls supporting the areas of manufacturing, laboratory, utilities, and processes
- Comparability protocols and re-validation of existing equipment and operations
- Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility
Our broad range of Pharmaceutical Quality Assurance consulting services include:
