Quality Control / Microbiology

  • Total Quality Management of Microbiological Quality Control
  • Microbial Risk Assessment
  • Investigating Microbial Contaminations
  • 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
  • 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
  • Laboratory and stability data analysis and reports
  • Developing and modifying test methods, SOPs, and specifications
  • Training of personnel in executing environmental monitoring and water monitoring programs, microbiological methods, and aseptic techniques

Process Developnemt and Validation

  • Pharmaceutical Equipment Development (User Requirement Specifications and Vendor assessment).
  • Equipment Cleaning Validations
  • Aseptic Process Design and Development
  • Barrier Isolator System development, and implementation
  • Aseptic Process Simulation Testing Protocols / Management
  • Sterilization Cycle Development (Gamma Irradiation, E-Beam, Ethylene Oxide, Vapor Hydrogen Peroxide, Steam and Dry Heat Sterilization)
  • 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
  • Document Control Systems setup
  • GAP Analysis and assistance with preparations for Pre-Approval Inspections, routine FDA Inspections and State Licensure Inspections
  • Establishment and maintenance of Risk Management programs
  • 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
  • GMP Training

Facility, Utilities and Equipment Validation

  • Validation / cGMP Review of Design Documentation
  • Validation Project Planning and Management
  • Validation Execution and Documentation-Parenterals, Biotech, Solid Oral Dosage, Drug Delivery Device, Packaging
    • Manufacturing Systems and Equipment Qualification/Validation- FAT, SAT, Commissioning, IQ, OQ, PQ
    • Laboratory Equipment- IQ, OQ, PQ packages for analytical systems
    • Facility and Utility System Validation- Commissioning, IQ, OQ, PQ
  • Validation Documentation and Training Support
    • Production Records Preparation
    • Protocols and Reports
    • Standard Operating Procedures
    • Preventive Maintenance Procedures
    • Cleaning Procedures
    • Turn Over Package Preparation
    • Training Services
3 Cs for Microrite

Three Cs for Microrite

C1: Creativity - We believe that creativity, not additional capital, generates the most effective solutions. This is the reason why we use a risk based approach and quality by design approach in all our work.

C2:  Communication - We have no secrets and give no surprises. We always will tell you what is happening and teach you everything we know. We communicate!

C3: Cost conscious - We help you succeed by treating your project as our business. Establishing phase specific systems to avoid overkill and overspending is our specialty.

Do it Once...Do it Right!