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VITA Consulting

Expertise 01

GxP & Regulatory Compliance

Regulatory expectations continue to evolve across markets, modalities and technologies. VITA helps organisations interpret GxP requirements, translate them into workable processes and maintain a state of control that stands up to inspection.

Services

  • GMP
  • GDP
  • GCP
  • GxP compliance
  • Regulatory requirements
  • Regulatory strategy
  • Quality and compliance advisory
  • EU GMP Annex 1 implementation & gap analysis
  • Contamination Control Strategy (CCS) development
  • GMP audits (internal, supplier & CMO)

Typical challenges

  • Interpreting changing EU, FDA and international guidance in a consistent way
  • Closing gaps identified in internal audits or regulatory inspections
  • Aligning compliance obligations across sites, partners and suppliers
  • Balancing compliance rigour with operational efficiency

How VITA can support

  • Independent GxP gap assessments and remediation roadmaps
  • Regulatory strategy aligned with product and business objectives
  • Practical advisory on applying requirements to day-to-day operations
  • Inspection readiness preparation and support

Regulatory frameworks we work with

EU

  • EU GMP – EudraLex Volume 4, Part I & II
  • EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
  • EU GMP Annex 11 – Computerised Systems
  • EU GMP Annex 16 – Certification by a Qualified Person and Batch Release
  • EU GMP Annex 22 – Artificial Intelligence (draft)
  • EU GMP Inspection Readiness
  • EU Directive 2001/83/EC, Article 51
  • EU Regulation 178/2002
  • REACH

FDA

  • FDA Inspection Readiness & Preparation
  • FDA 21 CFR Part 11 – Electronic Records & Signatures
  • FDA 21 CFR Part 111 – Dietary Supplements
  • FDA 21 CFR Part 117 – Human Food
  • FDA 21 CFR Part 507 – Animal Food

GxP & ICH

  • GDP – Good Distribution Practice
  • GCP – Good Clinical Practice
  • ICH Q9 – Quality Risk Management
  • ICH Q10 – Pharmaceutical Quality System

ISO & Food/Feed Safety

  • ISO 9001 – Quality Management Systems
  • ISO 13485 – Medical Devices Quality Management Systems
  • ISO 22000 / FSSC 22000 – Food Safety Management & Certification
  • GFSI – Global Food Safety Initiative
  • FAMI-QS – Feed Safety and Quality Management System
  • NSF/ANSI 455-2 – Dietary Supplement GMP Certification

Related expertise

Quality Management & ValidationSpecialist Consulting & Advisory

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