Overview

AVIVA provides comprehensive pharmaceutical facility consultancy services, helping you design, build, and maintain GMP-compliant facilities that meet domestic and international regulatory requirements (Schedule M, WHO, FDA, EU-GMP).

Facility Design & Layout

  • Concept layout preparation as per process flow
  • Man and Material movement optimization
  • Clean room classification and zoning
  • HVAC system logic and pressurization planning
  • Utility requirement estimation

Regulatory Compliance

  • Gap Analysis and GMP Audits
  • Preparation of URS (User Requirement Specification)
  • Validation Master Plan (VMP)
  • SOP (Standard Operating Procedure) preparation
  • DQ, IQ, OQ, PQ Protocols and Reports

Validation Lifecycle

1. VMP

Validation Master Plan creation outlining the scope and strategy.

2. DQ / IQ

Design & Installation Qualification to verify equipment matches specs.

3. OQ / PQ

Operational & Performance Qualification under load conditions.

4. Handover

Final summary reports and training for ongoing compliance.

STANDARDS WE COVER

Ensuring your facility meets the most stringent global regulatory requirements.

WHO GMP

World Health Organization standards for global pharmaceutical manufacturing excellence.

US FDA

Compliance with 21 CFR Part 210/211 for facilities exporting to the United States.

EU GMP

Stringent European Union Good Manufacturing Practice standards for medicinal products.

Schedule M

Indian Regulatory Requirements for pharmaceutical factory premises and equipment.

ISO 14644

International standards for clean rooms and associated controlled environments.

ASHRAE

Global HVAC design and engineering standards for industrial and commercial systems.