cGMP Validation provides Commissioning and Qualification services for a wide variety of process equipment, including, but not limited to, the types listed below.
  • Bioreactor Systems
  • Incubators
  • Blenders
  • Fermentor Systems
  • Reach-In Freezers
  • Fluid Bed Dryers
  • Reaction Vessel Systems
  • Reach-In Refrigerators
  • Spraydryers
  • Media Prep Vessel Systems
  • Warehouse Coolers
  • Granulators
  • Mixers, Agitators
  • Warehouse Freezers
  • Tablet Presses
  • Filtration Systems
  • Stability Chambers
  • Encapsulators
  • Glassware, Parts Washers
  • Laminar Flow Units
  • Solid Dosage Fillers
  • Autoclaves, Sterilizers
  • Biosafety Cabinets
  • Capping Equipment
  • Depyrogenation Ovens & Tunnels
  • Fume Hoods
  • Label & Packaging Equipment
  • Sterilization Tunnels
  • Isolators, Glove Boxes, RABS
  • Inspection Systems
  • Aseptic Processing Equipment
  • Vial, Ampule Fillers
  • Centrifuges
  • Raw Material Dispensing Systems
  • Laser Drillers
cGMP Validation also provides Factory Acceptance Testing and Site Acceptance Testing support.
cGMP Validation provides Commissioning and Qualification services for a wide variety of utility systems, including, but not limited to, the types listed below.
  • Chilled Water / Glycol Systems
  • Compressed Air Systems
  • USP / PW Water Generation and Distribution Systems
  • Compressed Gas Systems
  • WFI Generation and Distribution Systems
  • HVAC Systems
  • Plant Steam Systems
  • Waste Neutralization Systems
  • Pure / Clean Steam Systems
  • Tank Farms
  • Clean-In-Place Systems
  • Steam/Sterilize-In-Place Systems
cGMP Validation also provides Factory Acceptance Testing and Site Acceptance Testing support. cGMP Validation also provides Commissioning and Qualification services for facilities, including those required to demonstrate compliance with an air quality or international standard, such as:
  • Cleanroom / Controlled area construction
  • HVAC Performance Qualification
  • Environmental Baseline studies
  • Preparation of SOPs for process flow

cGMP Validation provides Qualification services for a wide variety of utility systems, including, but not limited to, the types listed below.

  • Biorobotic Systems
  • GC, HPLC and Software
  • Weighing and Dispensing Systems
  • Microplate Readers
  • DNA and Peptide Sequencers
  • Laboratory Centrifuges
  • Laboratory Information Management Systems

cGMP Validation provides Validation services for many process, including, but not limited to, the types listed below.

  • Analytical Methods Validation
  • Aseptic Process Validation
  • Methods
  • Process Transfer
  • Assay Validation
  • Cleaning Validation
  • Environmental Baseline Studies
  • CIP / Cleaning Validation
  • Shipping Validation
  • SIP / Sterilization Validation

cGMP Validation provides Validation services for Product Validation (Rx and OTC):

  • Parenterals
  • Tablets / Caplets
  • Liquids
  • Ointments
  • Suspensions
  • Powders

cGMP Validation offers many services to aid clients in meeting regulatory and compliance expectations including, but not limited to, the following:


cGMP Validation offers specialized auditing service of vendors, suppliers and contract laboratories. cGMP can assist you in building a vendor qualification program for raw materials or services.

Risk Assessments

cGMP Validation also provides internal auditing services and can provide a report based on quantitative evaluations of programs, procedures, policies, and practices at your site(s). Relative risk of each parameter or area reviewed will provide prioritization awareness needed to successfully remediate any situations not in compliance with agency, industry, or internal standards.

Regulatory Consulting

cGMP Validation helps clients develop and implement sound cGMP compliance strategies. cGMP Validation can assist your company with these and other compliance an regulatory activities.

  • Preparation for FDA inspections, particularly pre- and post-approval inspections
  • Evaluation of Quality Systems with quantitative evaluation reports
  • QA / QC documentation review
  • Development of Quality Systems
  • Plan Presentations to FDA
  • Development of Quality System SOPs
  • Design Reviews
  • Responses to FDA observations or action

cGMP Validation offers on-site training for client staff and management, as well as for your vendors and / or contractors. Common topics include:

  • Good Manufacturing Practices (21CFR 210, 211)
  • Validation protocol generation and execution
  • FDA Pre- and Post-Approval Inspections
  • Current Industry Trends
  • Client SOPs
  • Facility Design

cGMP Validation can develop a custom training program for you company’s internal procedures.

cGMP Validation will provide training course documentation suitable for your training records.

cGMP Validation has experience in all areas of computer and automation validation. cGMP Validation has led computer validation projects for the following representative systems:

  • Computerized Systems Validation, support documentation development
  • Computerized Systems Guidelines Development
  • Computerized Systems Configuration
  • Laboratory Management Systems (LIMS)
  • Software Quality Assurance and Quality Control
  • Building Management Systems (BMS)
  • Automation / Controls System Validation for temperature, humidity, access control, and similar functions
  • Supervisory Control and Data Acquisition Systems (SCADA)
  • Programmable Logic Computers / Controllers (PLC)
  • Data Migration Plan development
  • Bar code, material handling, inspection systems, and process monitoring systems
  • GMP / GAMP Compliance Assessment and Remediation
  • 21CFR Part 11 Assessment and Remediation

cGMP Validation can help you understand and implement a risk-based approach to compliance with 21CFR Part 11, rooted in the Final Guidance for Scope and Application provided by FDA.

Our experience will help you determine the Part 11 relevance to your processes.

Our staff maintains certification and ongoing education to be able to provide advice in which you can be confident.

cGMP Validation can provide all phases of activities needed for compliance with this regulation from gap-analyses and remediation planning for existing systems to prospective assessments of new systems.


cGMP Validation preparation of specialized documentation such as:

  • Validation Master Plans
  • User Requirements Specifications

cGMP Validation preparation of specification documentation and Standard Operating Procedures for:

  • Utilities
  • Preventive Maintenance Procedures
  • Process Equipment
  • Calibration Procedures
  • Laboratory Equipment
  • Processes
  • Labeling
  • Sample Handling
  • Environmental Monitoring
  • Quality Systems


Medical Device
Animal Health-Compliance
API / Bulk / Finished Pharmaceutical Facilities
Please contact us for additional Services.