Cleanroom Microbiology
Contamination Control
Environmental Monitoring
Disinfectant Qualification
and Cleaning Procedures
Fungal Identification


Quality Control Microbiology
  • Investigating Microbial Contaminations
  • Risk assessment
  • Total Quality Management of Microbiological Quality Control
  • 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
  • Training of personnel in executing environmental monitoring and water monitoring programs, microbiological methods, and aseptic techniques
  • 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 to facilitate timely review and action
  • Laboratory and stability data analysis and reports
  • Performance of validation audits and report reviews
  • Developing validation protocols and reports
  • Developing and modifying test methods, SOPs, and specifications

Process Development and Validation
  • Pharmaceutical Equipment Development ( User Requirement Specifications and Vendor assessment).
  • Equipment Qualifications (FAT, SAT, IQ, OQ and PQ Protocols)
  • Equipment Cleaning Validations
  • Aseptic Process Design and Development
  • Barrier Isolator System development and implementation
  • Aspetic Process Simulation Testing Protocols / Management
  • Sterilization Cycle Development (Gamma Irradiation, E-Beam, Ethylene Oxide, Vapor Hydrogen Peroxide, Steam and Dry Heat Serilization)
  • 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


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
  • Implementing Paper Based Document Control Systems
  • Implementing Electronic Document and Training Tracking Systems
  • Assistance with preparations for Pre-Approval Inspections, routine FDA Inspections and State Licensure Inspections.
  • Establishment and maintenance of Risk Management programs
  • Developing of tracking systems for 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
  • GAP Analysis
  • GMP Training

Manufacturing Support
  • Assistance with manufacturing related documentation
  • On site training and qualification of manufacturing personnel in aseptic techniques
  • Master Cell Bank manufacture and re-certification
  • Developing batch records and implementing effective pre and post batch record execution documentation to reduce deviations
  • Implementation of Paper Based and Electronic Materials Management Systems
  • Project Management
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