Discovery & Project Initiation

This stage is the critical starting point where the project foundations are laid and the entire process begins to take shape.

User Requirements (URS)

The production facility’s technical and operational requirements are defined, including the product portfolio, capacity targets, hygiene classification and regulatory expectations.

Project Brief

The scope, objectives, budget, milestones and schedule are established, and stakeholders and responsibilities are defined.

Preliminary Project

Multiple solution alternatives are developed for the project, and the feasibility of each is evaluated.

Alternative Project Planning

Different layout designs, process flows and equipment configurations are examined.

Draft Feasibility Study

A preliminary assessment is performed in terms of cost, CAPEX/OPEX, schedule, risk and regulatory compliance.

Infrastructure and Utility Systems Design & Planning

All utility systems supporting the production areas are designed.

HVAC

Capacity and control strategies are defined for systems managing temperature, humidity, particle count and differential pressure.

DI / WFI Water Systems

GMP-compliant purified water and water-for-injection production, storage and distribution lines, together with their qualification and validation stages, are planned.

Compressed Air

A purity and distribution infrastructure meeting oil, particle and moisture criteria is established.

Heating & Cooling Systems (Mechanical & Electrical)

Chiller/boiler selection, energy efficiency and return principles are defined.

Production Areas Design & Planning

Production areas are designed to be efficient, cost-effective and GMP-compliant.

Layout Plans

Layouts are created according to product/process flow, ensuring ergonomics and the prevention of cross-contamination.

Cleanroom Concept

Cleanliness classes, pressure cascades, personnel/material flows, airlocks and gowning areas are planned.

Laboratory Design & Planning

Laboratories with the infrastructure required to assure product quality are established.

Quality Control Laboratory

Areas are designed for analytical methods, sample flow and storage conditions.

Microbiology Laboratory

Biosafety, microbiological testing, sterility testing, incubation and waste management are planned.

Mechanical & Electrical Equipment

Requirements for gases, ventilation, extraction, UPS and grounding are defined.

Production & Laboratory Equipment

Equipment suitable for process requirements is selected and a procurement strategy is developed.

Proposal & Consulting

Consulting is provided during equipment selection based on technical suitability, capacity and sustainability criteria.

Compliance

Compliance with GMP and regulations, product-contact surface criteria and cleanability is evaluated.

Selection

Capacity, automation level, service availability and access to spare parts are considered.

Installation and Qualification

Installation and verification activities are performed.

DQ – IQ – OQ

• DQ (Design Qualification): Documentation demonstrating that the design complies with the URS and regulations.
• IQ (Installation Qualification): Verification that equipment/systems have been installed correctly and documentation is complete.
• OQ (Operational Qualification): Demonstration that operational parameters meet the acceptance criteria.

Commissioning / Start-Up

The facility is operated under real conditions, performance is monitored and optimizations are made.

• Trial production runs are performed.
• Personnel training is completed and SOPs are implemented.
• The root causes of issues are analyzed and eliminated.

GMP Documentation

The complete documentation structure required for process sustainability and traceability is established.

Scope

• ISO Standards
• EU-GMP
• US FDA 21 CFR
• Quality System Documents

Documentation Structure

• Procedures, instructions, forms and record templates are prepared.
• Change control, deviation, CAPA and risk management processes are defined.

Validation & Audit Preparation & Training

The facility is prepared for official inspections.

• Process, cleaning and analytical method validations are performed.
• Audit scenarios and mock audits are conducted.
• Personnel receive GMP- and audit-focused training.

Project Completion

The project is completed successfully and the facility is handed over.

• Üretime geçiş ve operasyonel devir yapılır.
• Performans ve kapanış raporları hazırlanır; edinilen dersler kayıt altına alınır.