GMP Validation and Compliance Requirements:
GXP Consultants offers the highest quality of Regulatory Audit Services with our former FDA Investigators and can supply you with paperless Electronic Documentation Management Systems (EDMS) in addition to Quality Validation for Biotechnology, Pharmaceutical, Medical Device and Diagnostics, Facility and Utilities, Equipment, Methods and Computer Validation.
GXP Consultants is committed to providing our clients with a superior level of validation consulting and testing services and keeping them current with validation issues, standards and trends. GXP Consultants dedicated validation laboratories provide you with your validation testing and methods development needs.
GXP Consultants is the solution for your validation and compliance needs offering:
- Validation Master Planning and Gap Analysis
- Validation Project Management
- Commissioning and Qualification
- IQ, OQ, PQ Generation and Execution
- Cleaning Validation Protocol and Method Development
- Process Validation Protocol and Method Development
- Design of Experiments (DOE) for Process and Cleaning Validation
- Analytical Methods Validation Protocol and Method Development
- Computer Validation and 21 CFR Part 11 Compliance
- Pharmaceutical Water Testing
- Pharmaceutical Facility Environmental Monitoring Testing
- Microbiological and Sterility Testing
- Cleaning Agent Effectiveness Testing
- Extractables and Leachables Testing for Disposables
- Residual Solvent Testing for Drug Products, Substances and Excipients
Our Validation / Calibration experts have at least a decade of experience and state of the art equipment.
GXP Consultants responds quickly and effectively to fast track projects, providing efficient Project Management and Planning using advanced project management techniques. Together we can achieve world-class results in regulatory compliance by providing superior validation services for automated systems.
Our staff is uniquely qualified to help our clients assess and define their validation requirements. GXP Consultants provides validation for both sterile and non-sterile facilities and associated utilities commissioning, qualification and validation. GXP Consultants can assist you with the development and/or review of functional requirements, system design review, requests for proposals, system specifications, development of standard operating procedures and preventive maintenance records and vendor evaluations and audits.
GXP Consultants dedicated GMP laboratories will provide you with comprehensive support for Compendial Testing, Analytical Method Development and Validation for Drugs and Biologics, Viable (Microbiological) and Non-Viable Testing for Pharmaceutical Facility, Water and Steam, Drug and Biologic Product Stability Testing and Validation, Extractable and Leachables for disposables and Residual Solvent Testing for Drug substances, products and excipients.
13681 Newport Avenue
Suite 8-620
Tustin, CA 92780
(714) 325-8896
