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Quality Control / Microbiology
- Total Quality Management of Microbiological Quality Control
- Microbial Risk Assessment
- Investigating Microbial Contaminations
- Plant sanitization problem solving, biocontamination control and risk analysis
- Selection and qualification/validation of disinfectants for the manufacturing facilities
- Assistance with facility design for contamination control
- Cleanroom performance qualification (PQ) protocols and reports
- Development of programs for environmental monitoring, water monitoring and compressed gases monitoring
- Writing/modifying procedures per current compendial requirements
- Protocol development and validation of microbiological assays and equipment
- Auditing QC microbiology laboratories, contract laboratories and microbiological aspect of manufacturing
- Analyze and prepare FDA 483 responses
- Designing efficient workflow systems for QC laboratories
- Laboratory and stability data analysis and reports
- Developing and modifying test methods, SOPs, and specifications
- Training of personnel in executing environmental monitoring and water monitoring programs, microbiological methods, and aseptic techniques
Process Developnemt and Validation
- Pharmaceutical Equipment Development (User Requirement Specifications and Vendor assessment).
- Equipment Cleaning Validations
- Aseptic Process Design and Development
- Barrier Isolator System development, and implementation
- Aseptic Process Simulation Testing Protocols / Management
- Sterilization Cycle Development (Gamma Irradiation, E-Beam, Ethylene Oxide, Vapor Hydrogen Peroxide, Steam and Dry Heat Sterilization)
- Microbiological Control (bioburden and endotoxin) in Pharmaceutical and Medical Device Manufacturing systems
- Aseptic Spray Drying Development for API particle engineering
- Nondestructive testing protocol development for device quality assurance
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Quality Assurance and Compliance
- Developing and streamlining Quality Systems
- Management of Quality Assurance Function
- Developing and revising of Quality Assurance documents and procedures for Compliance
- Document Control Systems setup
- GAP Analysis and assistance with preparations for Pre-Approval Inspections, routine FDA Inspections and State Licensure Inspections
- Establishment and maintenance of Risk Management programs
- Deviations, Out of Specification Results, Corrective Actions and Quality Investigations and Change Control
- Annual Product and Quality Reviews
- Establishing quality agreements and service agreements with CMOs
- Technology Transfer Documentation
- Assistance with Internal, External and Vendor Audits
- Data compilation, review and reports for regulatory filings
- GMP Training
Facility, Utilities and Equipment Validation
- Validation / cGMP Review of Design Documentation
- Validation Project Planning and Management
- Validation Execution and Documentation-Parenterals, Biotech, Solid Oral Dosage, Drug Delivery Device, Packaging
- Manufacturing Systems and Equipment Qualification/Validation- FAT, SAT, Commissioning, IQ, OQ, PQ
- Laboratory Equipment- IQ, OQ, PQ packages for analytical systems
- Facility and Utility System Validation- Commissioning, IQ, OQ, PQ
- Validation Documentation and Training Support
- Production Records Preparation
- Protocols and Reports
- Standard Operating Procedures
- Preventive Maintenance Procedures
- Cleaning Procedures
- Turn Over Package Preparation
- Training Services
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