Virtual Manufacturing Support
We provide a full range of quality and manufacturing operations support, including development of manufacturing and sourcing strategy, identification of development and manufacturing partners, due diligence support, technical contract negotiation (development agreements, supply and technical agreements), CMC writing, development of quality programs including quality manuals, building of manufacturing and quality organizations, set-up of quality control laboratories, drafting of guidelines and procedures, audit of suppliers and potential partners, and review of CMC documentation. We can support manufacturing operations in the active ingredient, pharmaceutical dosage form, medical device, nutritional, and diagnostics fields.
Specialty Programs:
Process Analytical Technology (PAT)
BAI Partners are experienced in the development of enterprise-wide PAT Strategies, and speak
internationally on the case for PAT development and implementation. We can help you with:
- Overall PAT vision
- Development of a Business Case and justification for PAT
- Description of the AS IS state
- Description of the TO BE state
- GAP analysis
- Development of a roadmap to move from AS IS to the TO BE (CAPEX and OPEX budget needed, organization needed, equipment and skills needed, etc)
Aseptic/Sterile Processing Guidance
With our in-house microbiologist and aseptic processing expert, as well as several partners who have managed quality operations for sterile manufacturing sites world-wide, BAI is uniquely suited to help address a wide variety of issues regarding manufacture, validation, and control of sterile products manufacture. From review of sterile facilities design through design of environmental monitoring and media fill programs, failure investigation, GMP assessment, and equipment qualification and process validation expertise, BAI can fill you sterile processing support needs.
Validation Programs
BAI Partners have extensive experience with all aspects of process and laboratory validation technology including computerized systems and CFR part 11 compliance. BAI will take a team approach in developing the appropriate documentation from Validation Plans and User Requirements to IQ, OQ, PQ protocols. We can also assist you with specialized validation requirements such as:
- Stability Chambers and Walk-in Room qualification, Uniformity Testing to assure compliance to ICH Guidelines
- Validation of Environmental Parameter Monitoring (temperature, humidity, differential pressure, etc.) or Data Logging Systems
- Qualification of Laboratory Glassware Washers
- Validation of Manufacturing and Packaging Systems
Visual Inspection Programs and Parenteral Product Assessment
BAI can evaluate existing programs or develop new Visible Particulate Matter/Defect Inspection and Testing programs in parenteral facilities. Our specialty is to assist organizations new to visual inspection in fast tracking the basic inspection program development by providing essential background, training and guidance in a condensed time period. Our evaluations include reviewing/discussing/planning the following:
- Visual Inspection Practices/Procedures in Manufacturing
- Visual Inspection Practices in QA
- Inspection Booth Specifications and Vendor Selection
- Visual Inspection Test Standards for Particulates
- Visual Inspection Test Standards for Container/Closure Defects
- Visual Inspector Training & Qualification in Manufacturing and QA
- AQL Sampling Plans
- Acceptance Criteria & Referee Strategy
- Documentation Requirements (SOPs, etc.)
- Component Level Inspection and Preparation
- Customer Complaint Monitoring and Feed-Back
- Automated System Qualification
Particle Science in Process and Product Quality Troubleshooting
BAI has an experienced Microscopist on staff and can assist facilities with source determination of particulate matter problems or contamination events such as glass occurrences in finished product vials. Other focus areas where we can assist you in controlling particles are:
- Establishing a program of monitoring Intrinsic or Extrinsic Particulate Sources relating to products
- Systematic Particle Classification/Identification for Product Profiling
- Determination of washing, processing or filling equipment particulate contribution to the final product
- Assistance in establishing an internal Investigative Microscopy Laboratory
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