Compliance with GMP and GxP requirements (QMS)
At AVISAN, we provide validation services with a comprehensive and specialized approach, in compliance with GMP requirements and the requirements of international authorities (WHO, EU‑GMP, PIC/S, and FDA). We ensure that equipment, processes, systems, and manufacturing environmental conditions are scientifically and documentarily validated to ensure product quality, safety, and efficacy.
- Consulting and internal auditing for GMP compliance
- Preparation for inspections by the Ministry of Health, EMA, and FDA
- Gap Analysis and preparation of a corrective action plan (CAPA Plan)
Strategy development
Development of a validation strategy and comprehensive Validation Master Plan (VMP)
Design and Implementation of Installation Tests
Design and Implementation of Installation, Operational, and Performance Tests (IQ/OQ/PQ)
Equipment Process Validation
Validation of Process Equipment, Water Systems, HVAC, CIP/SIP, and Utility Systems
Cleaning Validation
Cleaning Validation and Design of Washing Schemes
Manufacturing Process Validation
Manufacturing, Packaging, and Transportation Process Validation
Documentation of Stages and Readiness
Precise Documentation of All Stages and Readiness for Audits
By leveraging industrial experience and up‑to‑date knowledge, we deliver validation services in a manner that is accepted by the Food and Drug Administration, as well as international regulatory authorities.
