Pharma Facility Consultancy

Expert consultancy for pharmaceutical facility design, compliance, and optimization

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

WHO GMP

World Health Organization Good Manufacturing Practices.

US FDA

21 CFR Part 210/211 compliance for US market export.

EU GMP

European Union GMP standards for pharmaceutical manufacturers.

Schedule M

Indian GMP Regulatory Requirements.

ISO 14644

Clean Room Classification and testing standards.

ASHRAE

Global standards for HVAC design and operation.