Upgradation of Domestic Site to Regulatory

Upgradation of Domestic Site to Regulatory

Upgrading a domestic site to meet regulatory standards involves a comprehensive process to ensure compliance with the regulations and standards set forth by regulatory authorities such as the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA), etc. MASUU has vast experience in this field as it has inspectors who have worked in US FDA, MHRA, ANVISA earlier. Steps involved in upgradation of a domestic site to regulatory site are gap assessment, regulatory requirements analysis, action plan development, upgradation of infrastructure, implementation of QMS, Personnel training & Qualification, Documentation & Record keeping, Regulatory submissions, Audits and inspection preparation, continuous improvement, engagement with regulatory authorities, post upgrade monitoring and maintenance, etc. By following these steps and dedicating resources to upgrading the domestic site to regulatory standards, MASUU can ensure compliance with regulatory requirements, enhance product quality and safety, and maintain market access for clients’ products.

  • ✅ US FDA (United States Food and Drug Administration)
  • ✅ EMA (European Medicines Agency)
  • ✅ MHRA (Medicines and Healthcare products Regulatory Agency – UK)
  • ✅ ANVISA (Brazilian Health Regulatory Agency)
  • ✅ TGA (Therapeutic Goods Administration – Australia)
  • ✅ WHO-GMP (World Health Organization – Good Manufacturing Practices)
  • ✅ Other global regulatory bodies

    • With a team of former inspectors from US FDA, MHRA, and ANVISA, MASUU brings in-depth regulatory expertise to help organizations achieve compliance efficiently and successfully.

    Our Comprehensive Approach to Site Upgradation
    1. Gap Assessment & Regulatory Requirements Analysis
    • Thorough evaluation of the existing infrastructure, processes, and documentation
    • Identification of gaps between the current state and regulatory expectations
    • Customized roadmap to address compliance deficiencies
    1. Development of an Action Plan
    • Creation of a detailed implementation strategy to upgrade the facility
    • Timelines, responsibilities, and resource allocation planning
    • Risk-based approach to prioritize critical compliance areas
    1. Infrastructure Upgradation
    • Modification and expansion of cleanrooms, HVAC systems, utilities, and equipment
    • Implementation of environmental monitoring and contamination control systems
    • Compliance with facility design as per international regulatory guidelines
    1. Implementation of Quality Management System (QMS)
    • Development and refinement of Standard Operating Procedures (SOPs)
    • Implementation of robust Quality Risk Management (QRM) systems
    • Establishing Good Documentation Practices (GDP) and Data Integrity measures
    1. Personnel Training & Qualification
    • Comprehensive GMP training programs for employees and management
    • Qualification and validation of personnel as per global regulatory standards
    • Continuous learning modules for compliance awareness
    1. Documentation & Record-Keeping
    • Establishing regulatory-compliant documentation systems
    • Preparation of batch manufacturing records, validation reports, and testing protocols
    • Ensuring electronic record-keeping (21 CFR Part 11 compliance) where applicable
    1. Regulatory Submissions & Compliance Documentation
    • Preparation of dossiers and submissions for regulatory approval
    • Assistance in filing applications such as ANDA, NDA, DMF, CEP, etc.
    • Coordination with regulatory authorities for approvals and clarifications
    1. Audit & Inspection Readiness
    • Conducting mock audits and pre-inspection assessments
    • Addressing audit observations and implementing corrective & preventive actions (CAPA)
    • Preparing teams for regulatory site inspections
    1. Continuous Improvement & Post-Upgrade Monitoring
    • Regular GMP audits and compliance checks
    • Integration of quality control measures to sustain regulatory status
    • Implementing technological advancements for efficiency and compliance
    1. Engagement with Regulatory Authorities
    • Liaising with regulatory agencies for clarifications, approvals, and compliance updates
    • Responding to queries and ensuring timely resolution of regulatory concerns
    • Facilitating regulatory meetings and site visits
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