Oxzan GXP Solutions Dubai

GMP QUALITY SERVICES DETAILS

FACILITY DEVELOPMENT SUPPORT & OPTIMIZATION

At Oxzan, we deliver specialized consultation and hands-on support for the design, development, and optimization of storage and distribution GxP facilities meticulously aligned with Good Distribution Practice (GDP) and Good Storage Practice (GSP) standards.

Whether you're building a new facility or enhancing an existing one, our tailored solutions ensure regulatory compliance, operational excellence, and sustainable performance. We build high-quality, and regulatory assurance that empower your business to thrive in a global marketplace.

Our Core Competencies:

COMPREHENSIVE DESIGN OF TEMPERATURE-CONTROLLED STORAGE FACILITIES

We provide end-to-end storage facility development tailored for sensitive products, ensuring quality and compliance every step of the way.

RETROFITTING AND OPTIMIZATION OF EXISTING WAREHOUSES

Transform your current infrastructure by retrofitting, upgrading, and improving operational costs.

STRATEGIC WORKFLOW PLANNING & CAPACITY MANAGEMENT

Streamlined processes that avoid bottlenecks by planning for scalability and adapting to changing business needs.

Why Choose Oxzan?

We ensure your FACILITIES is designed as one. Our functional team will steer to achieve the highest international regulatory standards today set for the future. Our expertise aligns specific requirements, providing actionable recommendations for excellence.

OUR APPROACH

Engineering GDP Compliance Through Science & Intelligence

A GDP-compliant facility is not built by chance—it is engineered through science, risk management, and regulatory intelligence. Our Facility Development Support & Optimization services are designed to help pharmaceutical, healthcare, and life-science organizations design, upgrade, and optimize distribution facilities that consistently protect product quality, ensure patient safety, and withstand regulatory scrutiny.

We support facilities from concept to compliance, ensuring that warehouse layouts, environmental controls, material flows, and monitoring systems are fully aligned with WHO GDP, EU GDP (2013/C 343/01), GCC Guidelines, and UAE MOHAP requirements. Our approach integrates quality by design (QbD) principles to eliminate compliance gaps before they become operational risks.

DESIGN EXCELLENCE

Intelligent Facility Design with GDP at the Core

We assist in the development and optimization of GDP facilities by evaluating layout design, zoning, segregation, and workflow efficiency to ensure unidirectional material movement, prevention of mix-ups, and effective control of temperature- and humidity-sensitive products.

Each design decision is supported by risk assessments, product profiles, and storage requirements, ensuring the facility is both compliant and operationally efficient.

Key Focus Areas:

Layout design & zoning
Workflow efficiency
Material segregation
Risk-based assessments

CLIMATE CONTROL

Environmental Control & Storage Optimization

Maintaining defined storage conditions is a fundamental GDP requirement. We provide expert guidance on HVAC system design, refrigeration solutions, humidity control, and backup systems, ensuring reliable performance under routine and worst-case conditions.

Our services include storage capacity optimization, hot/cold spot mitigation strategies, and preparation for temperature mapping and ongoing monitoring programs.

CRITICAL SYSTEMS

GDP-Focused Infrastructure & Utilities Support

We evaluate and optimize critical infrastructure such as power supply, alarms, security systems, access control, pest control, and waste management, ensuring uninterrupted operations and data integrity.

OPERATIONAL EXCELLENCE

Risk-Based Optimization

Beyond compliance, we help organizations improve space utilization, process efficiency, and cost control without compromising GDP principles through gap assessments, risk analysis, and continuous improvement strategies.

QUALITY ASSURANCE

Seamless Integration with Validation & Quality Systems

Facility development is closely integrated with qualification, validation, SOP development, and quality management systems. We ensure that all facility changes are properly documented, justified, and validated.

Our comprehensive approach supports smooth regulatory inspections and long-term compliance sustainability, giving you the confidence to focus on your core business operations while we ensure your facility remains inspection-ready at all times.

COMPUTER SYSTEMS

What is Computer System Validation - CSV?

The validation proves with documentation that computer systems used in industrial production adequately fulfill their automatic functions and contribute to ensure the traceability of produced batches and meets GMP regulations. Every computer system that has a direct or indirect relation to the production of the medicine, product for health or impact on traceability, must be validated, because it is a GxP system.

The first important activity of the Computer Systems Validation professional is to gather all the available documentation about the system which is object of the study.

METHODOLOGY

Validation based on risk approach

The study of the existing documentation to survey the risk scenarios is extremely important to know the particularities of the system to be validated and to meet cGMP guidelines. However, after some systems have been validated by the professional, some risk scenarios are invariably presented, such as the system behavior facing power outage, study of access profiles, access security, quality of electronic record produced by the system including audit trail, application of electronic signatures, etc.

It is important to emphasize that Functional Risk Assessment must be done by a multidisciplinary team due to the need of adopting mitigation measures for the risks which result in "medium" and "high" levels. The acceptance of these mitigation measures must be agreed among the team aiming to really be functional, whether they are adopting new work procedures or improvements in the system. The measures to be adopted become the validation strategy and they are the main points where GxP validation should focus.

Important Note

For the Functional Risk Assessment, the participation of the system supplier or developer is recommended. When this is not available, a professional can be hired with knowledge in this type of system that is being assessed.

VALUE PROPOSITION

Why do I need to validate?

In addition to contributing for data quality and data integrity, the GMP validation lifecycle is valuable because it allows:

Extracting all the needed available resources in the system to cover the specific process safely
Make the technical knowledge team more in-depth about the system, avoiding that the knowledge stays entirely on the hands of the supplier (opening the "black box")
Document technical discoveries, avoiding the loss of knowledge in an eventual exit of professionals of the company (risk to the business!)

Explore all possible automatic features in order to avoid manual steps, leading to repeatability and reproducibility for the process (target of validation!)
Direct the team to analyze necessary actions and documented procedures for contingency planning, data backup and application, and disaster recovery, reducing production downtime (risk to the business!)
Reliability of process information avoiding operational errors

PROCESS FRAMEWORK

Learn more about Validation Life Cycle

GAMP5® Validation Guide

GAMP5® is a Good Automated Manufacturing Practice guide, the 5^th version of 1^st edition was released in 2008. Recently, in 2022, they published the 2^nd edition of the guide. Since then, it has revolutionized the Validating Computer Systems method.

The guide is a set of "inspiration" for Computer Validation professionals and has as its central axis the risk-based validation strategy ("A Risk-Based Approach to Compliant GxP Computerized Systems").

Note: although each company has its specificity, there are several standard processes within a type of system, for example purchasing processes within an ERP, which are common to different companies. Taking this opportunity, FIVE has developed a paperless e-validation methodology to optimize efforts and ensure compliance.