Areas of Expertise
The GMP Group has significant experience in the design and construction of pharmaceutical manufacturing facilities.
The following typical of the type of expertise and services we can offer.
Facilities for Research and Development:
- Conventional Organisms
- Primary and Secondary Pharmaceuticals
- Biotechnology
Final Product Finishing and Packaging for:
- Parenterals (LVP and SVP)
- Tablets
- Topicals
- Ophthalmics
- Powders
- Capsules
- Liquids
- Transdermals
- Inhalers
- lmplantables
- Devices and Diagnostics
- Vaccines
- Lymphokines
- Antibodies
- Enzymes
- Amino Acids
- Therapeutic Products
- Vitamins
- Other Speciality Chemical and Pharmaceutical Products
Cell Culture
- Suspension Culture
- Micro Carrier
- Perfusion
- Hollow Fibre
Protein Purification
- Ultra filtration
- Gel Filtration
- Affinity Chromatography
- Ion Exchange
- HPLC
- Fractional Precipitation
Capabilities
- Personnel and Material Flow
- Lyophilisation
- Sanitary Design
- Aseptic Processing
- Water For injection and Purified Water Systems
- Clean Room Design
- CIP and SIP Systems
- Industrial Engineering Design
- Sterilisation
- Architectural Finishes
- Chemical and Biochemical Process Technology
- Simulation of Work Flow
- Particulate Control and Monitoring
- Automated Material Handling/Packaging Fermentation
- rDNA and Conventional Organisms
- Bacterial and Yeast Cultures
- Very Large Scale (up to 100,000 gallons) Bulk Chemicals
- Aerobic and Anaerobic Systems
- Robotics
- Automated Storage/Retrieval Systems (AS/RS Design)
- Computer Simulation, layout and Modelling
- Fermentation and Product Purification
- Liquid and Solid Dosage Manufacturing
- Aerosol Manufacturing
- Aseptic Fill
- Bio-Waste Treatment
- Controlled Substance Design
- Designs for NIH Bio-Safety Guidelines
- Training
- Computer Aided Design
Services:
The GMP Group can provide the following project services tailored to suit the client requirements.
Planning
- Master Strategic Planning
- Feasibility Studies
- Economic Analysis
- Site Search and Evaluation
- Site Master Planning
- Environmental Analysis
- Facilities Planning
- Manufacturing Resource Planning
- Capacity Analysis
- Technology Evaluations
Process Engineering
- Economic and Technical Evaluations
- Process Analysis
- Process Development
- Process Equipment Engineering
- Equipment Selection and Procurement
- Process Monitoring and Control
- Process Optimization
- Vendor Co-ordination and Qualification
- Systems Integration
- Product Delivery Systems
- Computer Integrated Manufacturing
- Turnkey Control Systems
- Operational Training
- Process Re-engineering
- Simulation
Engineering
- HVAC & Process Ventilation
- Clean Utilities
- Mechanical & Piping Systems
- Electrical
- Structural & Civil
- Life Safety & Fire Protection
- Security
- Telecommunications and Data
- Energy Management Systems
- Environmental Design
- Building Automation and Controls
- Manufacturing Automaton
- Software Development
- Equipment Specification
- O&M Manuals
- GMP Compliance
Management Services
- Project Management
- Quality Control
- Value Engineering
- Project Cost Control
- Estimating
- Scheduling
- Start Up and Commissioning
Architecture
- Planning & Building Regulations
- Building Design for Functionality
- Personnel & Material Flow
- Building Co-ordination
- Corporate Image Management
- Landscape Architecture
- Interior Design & Ergonomics
Construction Services
- Construction Management
- General Contracting
- Procurement
- Full-time Site Representation
- Contract Negotiations Estimating
- Cost Control
- Scheduling
- Field Expediting
- Maintenance
Regulatory Compliance and Validation
- FDA, DHSS, WHO Liaison
- GMP Training
- cGMP Compliance
- cGMP Audits
- Validation Master Planning
- FDA Design Review Assistance
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Process Qualification (PQ)
- Protocol Execution for:
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Automation Validation
- Calibration
- Environmental Monitoring
- Change Control