GMP Consulting

GMP consulting is an end-to-end service that ensures the manufacturing facility, its processes, and quality system meet the requirements of Good Manufacturing Practices (GMP). Envora Global addresses both physical facility compliance and quality system and organization.

Scope of GMP Consulting

• Current situation assessment: evaluation of the facility, equipment, and processes according to GMP requirements and improvement plan.
• Facility and infrastructure compliance: GMP layout plan, HVAC – clean room, DI water, and other critical systems.
• Quality management system and documentation: EU-GMP practices, procedures, and record-keeping systems.
• Training: recruitment and training of key personnel through GMP training.
• Qualification, validation, and audit preparation: preparation for official audits and customer audits.

Who Needs GMP Consulting?

Manufacturers of human, veterinary, and traditional herbal medicines, cosmetic companies (cosmetic GMP), food supplement manufacturers (GMP/HACCP), biocidal and medical device manufacturers benefit from our GMP consulting services. Whether you are establishing a new facility or preparing your existing facility for an audit, we will create a working plan tailored to your goals.

Operational Excellence with GMP

GMP compliance is not just a document but a sustainable way of working. Therefore, during the consulting process, we target efficiency and profit increase by introducing operational excellence practices such as lean manufacturing, process reliability, and risk management.

How Do We Work in the GMP Consulting Process?

We begin our work with a current situation assessment where we familiarize ourselves with your facility and processes on-site. This assessment addresses facility layout, infrastructure systems, equipment, documentation, and organization together. Then we prioritize the findings and prepare a feasible improvement plan and timeline.

The plan consists of concrete steps such as necessary facility arrangements, quality system documents, training, and qualification/validation studies. Throughout the implementation, we aim for the knowledge to remain within the institution by working closely with your team. The process ends with the preparation for official or customer audits.

Why Envora Global?

GMP compliance requires both engineering and quality knowledge simultaneously. Envora Global brings together experience in facility and infrastructure engineering with quality system and organization work within a single team. References ranging from Sandoz Pharmaceuticals to Novartis Pharmaceuticals demonstrate that we manage GMP projects across different scales and product groups.

GMP Consulting for New Facility Projects

Addressing GMP requirements at the very beginning of the design of a new production facility prevents costly changes that may occur later. The concept design, unidirectional process flow, and lean manufacturing principles in the Novartis Pharmaceuticals Kurtköy project and the concept design of the new human drug factory in the VEM Pharmaceuticals Çerkezköy project are examples of this approach. In cosmetic and food supplement facilities, the same method is employed; production areas, quality control laboratories, and infrastructure systems are planned together according to product forms.

In existing facilities, the priority is to implement improvements with minimal disruption to production. Improvements in GMP practices and renovations of laboratories and infrastructure systems in the Sandoz Pharmaceuticals Gebze generic drug factory are examples of such transformation.

All project planning and implementations are conducted in compliance with GMP (Good Manufacturing Practices) regulations, ISO and HACCP standards, and the requirements of the Ministry of Health / Ministry of Agriculture and Forestry.

Our Process in GMP Consulting Projects

1. Concept design: determination of product groups, capacity targets, material and personnel flows.
2. Project planning: design of GMP layout plan, HVAC – clean room, DI water, and other infrastructure systems.
3. Installation and implementation: clean room partition and panel systems, selection and installation of production machines.
4. Qualification and validation: verification of equipment, systems, and processes; commissioning.
5. Quality system and audit preparation: documentation, training of key personnel, and preparation for official audits.

Our Reference Projects

• Sandoz Pharmaceuticals Gebze Generic Drug Factory – Sandoz Pharmaceuticals, Kocaeli / Gebze (2006–2009): Improvement of GMP practices; EU-GMP documentation system.
• Mamsel Pharmaceuticals Production Facility Project – Mamsel Pharmaceuticals, Istanbul / Tuzla (2014–2015): human medicine, cosmetic, and biocidal production areas; concept design and redevelopment.
• DELTA Cosmetics FDA and GMP Consulting – DELTA Cosmetics, Istanbul (2021–2026): assessment and renovation of existing system; GMP consulting for FDA audit.
• ELIT Pharma Production and R&D Facility – ELIT Pharma, Istanbul (2025–2026): food supplement and cosmetic production areas; quality control and R&D laboratories.
• ELIT Cosmetics Production Facility – ELIT Cosmetics, Istanbul (2018): concept design and implementation of cosmetic production facility; GMP training and documentation.
• Sandoz Pharmaceuticals Levent Factory Renovation Project – Sandoz Pharmaceuticals, Istanbul / Levent (1989–1996): HVAC ventilation and air conditioning system; EU-GMP practices and factory renovation.

Let’s Plan Your Project Together

Contact Envora Global to assess your needs for your GMP consulting project and create your roadmap together.