Implementation of CGMP Compliance from concept to pre-approval
cGMP Compliance Technology Audit/Gap Analysis
  • Equipment and Facilities
  • Processes
  • Quality Systems
  • Documentation
  • Organizational Structure
  • Risk assessment
    • Enable companies to determine which qualification/validation/facilities & equipment upgrades are necessary
    • Provide support with the implementation of identified measures.
Development of the Conceptual Design
  • Prerequisite and a guide to prepare technical requirements document (User Requirements Specifications) for economical and functional preparation and implementation of detailed engineering design project for facility and equipment upgrade/retrofit/new construction within the cGMP framework, based on the regulatory Risk assessment and strategic business development plan or analysis
Preliminary Engineering Design
  • Field survey to confirm the layout of architectural system components and mechanical, electrical and plumbing infrastructure.
  • Preparation of material, personnel and equipment flow diagrams for all process areas.
  • Selection and defining utility requirements and Client`s needs associated with new and existing processes and equipment. Preparation of the process equipment list for Client`s review and approval that will form the basis for budgetary equipment costs. Organization (optional) of pre-selection of vendors and a bid process for the equipment to include US, European, Asian and local suppliers.
  • Preparation of Area Classification and Pressurization Plan drawings for each of the processing areas with reference to European Grade levels as appropriate.
  • Preparation room air change rate calculations and development of preliminary HVAC Zoning plans so that the assessments of existing and sizing of new HVAC equipment can be made.
  • Recommendation of the affecting set points for room temperature, humidity and pressurization, as well as acceptable operating, alert and action limits and how these will be monitored and controlled.
  • Preparation of a Validation Master Plan.
Engineering & Construction
  • Field Project Management
  • Design (Architectural, Civil, Structural, Mechanical, HVAC, Plumbing, Electrical, Process)
  • Purchasing/Expediting
  • Construction
  • Validation
  • Start-up / Commissioning
  • Manufacturing/Processing Personnel Training
Qualifications/Validations
  • Qualifications/Validations
    • Basic concepts
    • Master plans (a company specific qualification/validation concept)
    • Project specific master plan (GMP, Validation, SOPís)†
  • Qualification (DQ/IQ/OQ/PQ)
    • Development and preparation of all qualification protocols and relevant SOPís
    • Execution of the protocols (at customer request) or helping a customer to execute
    • Preparation of GMP compliant documentation describing the qualification activities for the customerís facility
  • Validation
    • Full technical and manpower support for preparation of protocols and reports and execution activities (although the latter is typically done by the manufacturer).
    • Scope Ė process, cleaning, analytical methods, computerized systems
    • Preparation of all necessary validation SOPís carefully adapted to the customerís needs
Documentation
  • Documentation
    • Technical support and execution (per customer`s request) of all necessary documentation
    • Scope - documentation concepts, SOP`s, production documentation (batch records, cleaning records, etc.), technical documentation (development reports)
    • Documentation review
    • Training
  • Preparation for inspection
    • Technical support and/or execution and follow-up services
    • Scope - Self audits, Audits of suppliers, Customer audits, Regulatory audits
  • Remediation (FDA 483`s, Warning Letters)
    • Technical support in preparation or execution of responses to local and/or international regulatory agencies (for example, EIR, 483`s and Warning letters)
    • Technical support in preparation and/or execution of the corrective and preventative action (CAPA) master plans
  • Regulatory Submissions
    • Technical support and/or execution and follow-up services
    • Scope - DMF, COS, Comparability protocols, CMC section
  • Training
    • Design of the comprehensive training program to cover initial and ongoing training requirements
    • Conducting general GMP and specific training sessions on continues basis