Services

Compliance, C&Q

MTG and Compliance

A global leader in life sciences engineering and technical solutions, Mentor Technical Group (MTG) has the knowledge and experience with the FDA and international agencies to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.

Our Compliance and C&Q Experts

MTG’s Compliance and C&Q experts are the perfect solution to your Performance Validation and Commissioning & Qualification needs, providing you with the regulatory and validation knowledge necessary to complement your business and handle your Utilities, Manufacturing, Packaging, and Computer System Validation needs.

From Consultation to Execution

MTG supports projects ranging from strategic consultation to execution of large-scale compliance programs, and provides the regulatory and validation knowledge necessary to complement your organization as a whole, allowing you to focus on your essential business goals and objective.

Our Compliance/Validation Services

Our Regulatory Compliance/Validation Services include:

  • Batch Certification
  • CAPAs
  • Cleaning Validation
  • Commissioning and Qualifications, Start-Up
  • Computer Systems Validation (SDLC)
  • CSV
  • Decommissioning
  • Engineering Studies
  • Environmental Monitoring Programs
  • Facilities & Utilities C&Q/Verification
  • Facilities, Utilities, Manufacturing/Packaging Equipment Qualification
  • Factory Acceptance Tests (FAT)
  • FDA Regulations Assessments
  • Functional Requirements Specifications
  • Information Technology Systems
  • Installation, Operational, Performance Qualification Protocols and Reports
  • Laboratory Equipment Validation
  • Laboratory Systems
  • Packaging Validation
  • Process and Packaging Equipment C&Q/Verification
  • Process Validation and Investigations
  • Process Validation/Revalidation
  • Quality Risk Assessments
  • Quality/Validation Master Plans
  • Regulatory Compliance Services
  • SOPs, Guidelines, Audits
  • Validation Project Management
  • Validation Services

Our New-Facility Construction Experience

MTG has new-facility construction experience that enables our team to coordinate validation activities concurrently with facility construction, commissioning, and start-up, thus assuring a higher quality installation and fulfillment of your critical schedule needs. We can perform:

  • Annual Product Reviews
  • Batch Record Certifications
  • Cleaning Validations
  • Commissioning, Start-up, and Factory Acceptance Tests (FAT)
  • Computer System Validation (including software, servers, and hardware)
  • Environmental Monitoring Programs
  • Facilities, Utilities, Manufacturing/Packaging Equipment Commissioning, and Qualification
  • FDA Regulations Assessment/Remediation
  • Laboratory Systems
  • Non-Conformance/Corrective Action Preventive Action (NC/CAPA)
  • Process Optimization/Cost Reductions
  • Process Validation and Process Investigations
  • Quality Assurance/Validation Master Plans
  • Regulatory Compliance Remediation for Engineering, Manufacturing/Packaging, and Quality Control/Assurance Observations
  • SOPs, Guidelines, and Audits

Our Efficient, Cost-Effective Compliance Processes

Our aim is to support the Manufacturing, Packaging, Technical Services, and Process/Packaging Engineering Staff in Pharmaceutical Process Design, Management, Process Control, Optimization, and Automation to obtain optimum world-class operations that result in efficient, cost-effective cGMP compliance processes. Our services include:

Process/Packaging Optimization and Improvements

  • Capacity Analysis Projects
  • Cleaning-in-Place Design and Support
  • Containment Operation Design and Support
  • Cycle Time Reduction
  • Equipment and Systems Improvements, PLC Automation, and Control Systems Configuration and Integration
  • In-process Testing Automation
  • Losses and Waste Reduction
  • Non-Compliance Elimination
  • Operational Efficiencies Metrics
  • Productive Time Maximization
  • Projects Justifications and Capital Appropriations Development
  • Quick Changeover (QCO) & Single-Minute Exchange of Die (SMED) Projects
  • Six Sigma, DOE, and DMAIC Solutions Implementation

Process/Packaging Process and Product Transfer

  • Process and Product Transfer Related Documentation Development
  • Process/Packaging Technology Transfer
  • Product Development Support
  • Product Transfer Strategy, Coordination, and Implementation

Process and Packaging Resources Outsourcing

  • In-process QA Specialists
  • Manufacturing and Packaging Operators
  • Manufacturing and Packaging Supervisors, Facilitators, or Assurers
  • Manufacturing and Packaging Technicians, Mechanics, or Specialists
  • Packaging Engineers
  • Parts Buyers
  • Process Engineers
  • Reliability Based Specialists
  • Spare Parts Coordinators

Our Laboratory Quality Operations

MTG supports Laboratory Quality Operations, providing managerial, technological, and regulatory compliance solutions for laboratory, equipment, and operations to help our customers satisfy their needs. Our experienced professionals, with a vast knowledge of Compliance and Pharmaceutical Plant Operations, can support you from the conceptual phase of your laboratory project through to its final implementation. We can provide personnel with expertise in the following areas:

Analytical Lab

  • Analysis Performance in Accordance with USP, NF, EP, BP, and Internal Procedures
  • Individual Laboratory Equipment Classification
  • IQ, OQ, and PQ Laboratory Instrument Protocols
  • Laboratory Equipment and Components Updates
  • Laboratory Equipment Calibration and Preventive Maintenance Program
  • Laboratory Equipment Validation Program
  • Laboratory Personnel Certification
  • Method Transfer for New Products Performance, including Protocols and Laboratory Testing
  • Minimum Laboratory Equipment File Requirements Update Reports
  • Outside Calibration Contractor Audits and Certification
  • Outsider Services Contractor Audits and Certification
  • Standard Operating Procedures for Laboratory Instruments Review
  • Verification, Analysis, and Certification of Laboratory Analyst and Chemist Raw Material, In-process, and Finished Products in Accordance with USP, NF, EP, BP, JP, and Internal Procedures

Microbiology Lab

  • Autoclave Certification
  • Autoclave/Annual Certification
  • Cleaning Validation
  • Data Reviewers
  • Environmental Monitoring and Qualifications
  • ID System (Biolog, Microscan, Celsis)
  • IQ, OQ, and PQ Laboratory Equipment Qualifications Protocols
  • Laboratory Equipment Qualifications Executions
  • Laboratory Equipment Validation Program
  • Laboratory Investigation
  • Laboratory Remediation
  • LIMS Systems
  • Media Qualification
  • Method Transfer for New Products Performance, including Protocols and Laboratory Testing
  • SOP Development and Revisions
  • USP, EP, and JP Laboratory Method Qualification
  • Water Systems Validation Using USP, JP, and EP Method