BB Consulting Offered Services
Each service is customized to the clients need to comply with US, ISO and/or EU regulations.
BBCS represents a third party, conducting cGMP and GLP compliance audits as well as computer validation, Part 11 compliance and PAI readiness audits.
- Automation Systems
BBCS delivers validation services for all types of automation systems. Control systems design, upgrades and qualification. In addition, BBCS has assisted in the design and development of new control systems.
- Cleaning Process Development & Validation
BBCS develops and qualifies cleaning processes for sterile parenteral and non-sterile manufacturing equipment.
- Change Control
BBCS handles and manages change controls during any validation or qualification project.
- Clinical Services
BBCS offers phase 1-3 clinical monitoring project management. In addition, we are ready to work with you on any ancillary projects to ensure that you remain in regulatory compliance, including SOP's, trial master filing (or device history filing), inspection readiness, IP accountability, monitoring report reviews, vendor oversight, etc.
- Compliance Services
BBCS delivers compliance services by developing QC, QA and validation standard operating procedures in addition to developing full validation programs to ensure continued compliance post qualification.
- GAMP 5 and 21CFR11 GAP Analysis
BBCS will evaluate specifications for new and computerized systems to ensure compliance with GAMP 5 and 21CFR Part 11.
- Equipment Qualification
BBCS delivers full equipment qualifications using the lifecyle approach congruent with the latest FDA guidance trends to ensure compliance and continued confidence.
- GMP Facilities Commissioning and Qualification
BBCS delivers commissioning and qualification services for new construction, and modifications of existing facilities. Refer to the list of deliverables for examples of BBCS capabilities. BBCS utilizes Stage 1 Process Design, Stage 2 Process Qualification and Stage 3 Continued Process Verification flow in addition to the lifecycle and risk based approaches as outlined in the most recent FDA Draft Guidance on Process Validation.
- Laboratory Systems Validation
BBCS works closely with major laboratory equipment vendors to provide initial and continued qualification status for critical equipment.
- Process Validation
Congruent with the latest FDA guidance trends, BBCS provides validation and qualifications for processes, equipment and systems. Refer to the quick reference list.
- Project Management
BBCS provides full validation and general project management capabilities.
- Quality Assurance Support
BBCS provides SOP writing, data review, batch record review and audits.
BBCS performs and delivers documentation from periodic and continued process verification on all qualified processes, systems and equipment.
- Sterilization Process Development & Validation
BBCS develops and qualifies sterilization processes for sterile parenteral manufacturing equipment and products.
- Temperature Mapping
BBCS uses their own NIST calibrated equipment for temperature mapping studies ranging from ultra low to depyrogenation temperatures. Both wired and wireless systems are available depending on the application.
- Validation Master Plans and Technical Writing
BBCS provides clients with a comprehensive Validation Master Plan in addition to assistance with technical writing needs.
Quick reference of capabilities and experience
- Site / Vendor Management
- Phase 1-3b Studies / 510 k
- Contract Negotiation
- SOP / Guidance Writing
- Data review
- Risk Based Monitoring
- Start-up and Final Report
- Clean Compressed Air
- Clean Steam
- Emergency Generators
- USP Purified Water
- Water for Injection
- QC Analytical Equipment
- Dry Heat and Depyrogenation Ovens
- Glassware Washers
- Process Equipment
- Refrigerators / Freezers
- Stopper / Vial Washers
QA / Specialty Projects
- Batch Record Review
- Gap Analysis
- Risk Assessment
- EN285 Clean Steam compliance testing
- QC Methods Validation
- Environmental Monitoring Programs
- Steam Sterilization Process Development
- Dry Heat Sterilization Process Development
- PAI Preparation Assistance
- Container Closure Integrity Studies
- Sanitization Validation Studies
- Testing Execution
- Protocols and Reports
- Annual Review / Periodic Qualification Reports
- Change Control Documentation
- Development Reports
- Audit report
- Environmental Monitoring Program
- Methods validations
- Aseptic Process Validation
- Wireless or TC Temperature mapping
(ultralow to depyrogenation)