GxP / GMP Consulting

DAS Engineers provides GxP and GMP consulting services to help pharmaceutical, healthcare and industrial organizations maintain compliant, controlled and inspection-ready operations.

Our GxP / GMP Consulting Services

  1. GMP Compliance Assessment
    GMP compliance gap assessment
    Facility and engineering compliance review
    Identification of compliance risks
    Corrective and improvement recommendations
  2. Quality & Compliance Consulting
    Quality-system support
    GxP compliance assessment
    Good Documentation Practices support
    Data integrity awareness and assessment
    Compliance improvement programs
  3. Engineering & GMP Compliance
    HVAC and cleanroom GMP assessment
    Utility-system compliance review
    Equipment and facility engineering assessment
    Engineering documentation review
    Qualification and validation support
  4. Documentation & SOP Support
    SOP development and review
    Engineering procedures
    Technical documentation
    Protocol and report review
    Documentation gap assessment
  5. Qualification & Validation Support
    Commissioning support
    IQ/OQ/PQ documentation
    HVAC qualification
    Utility qualification
    Validation planning and technical support
  6. Inspection & Audit Readiness
    Regulatory inspection preparation
    Internal audit support
    Mock inspection support
    Compliance-gap closure
    CAPA and improvement support

Regulatory Focus

Our consulting approach considers applicable GxP and GMP requirements, including WHO GMP, EU GMP principles and applicable Indian regulatory requirements.

Our Approach

DAS Engineers combines engineering knowledge with GxP/GMP compliance expertise to provide practical, risk-based and sustainable compliance solutions.