Pharmaceutical manufacturing is among the most regulated and technologically advanced industries, demanding continuous innovation and unwavering quality. GM PHARMA, an international pharmaceutical company with over 600 professionals in Georgia and abroad, prioritizes excellence by investing in ongoing professional development. Regular training ensures company teams uphold the highest industry standards.
Recently, GM PHARMA conducted a three-day seminar focused on the DoE–QbD framework – a comprehensive approach of quality planning in pharmaceutical product development. This seminar brought together company staff from Research & Development, Quality Control, and Quality Assurance departments to deepen their expertise in key areas: Design of Experiments (DoE) and Quality by Design (QbD).
Design of Experiments (DoE) is a systematic methodology that uses statistical techniques to plan, conduct, and analyze controlled tests. In pharmaceutical drug development, DoE helps identify how various factors—such as ingredient ratios or processing conditions—affect product quality. By optimizing these variables early on, a company can ensure robust formulations and efficient processes.
Quality by Design (QbD) is a proactive approach that embeds quality into every stage of product development and manufacturing. Besides relying on raw materials testing, in-process control tests and end-product testing, QbD emphasizes understanding all processes from the earliest stages of formulation and process design to ensure consistent outcomes throughout the product lifecycle.
The seminar was led by Dr. Shivang Chaudhary—a globally recognized expert in Quality by Design (QbD) and founder of QbD-Expert™—who shared practical insights drawn from his extensive experience in innovative drug development. He is the author of nearly 150 ready-to-use formulation templates designed to streamline the drug development process. Dr. Chaudhary’s platform is widely adopted in the development of both innovative and generic pharmaceutical products.
As Dr. Shivang Chaudhary notes:
“By embracing advanced methodologies such as Design of Experiments (DoE) and Quality by Design (QbD), GM PHARMA not only enhances new drug development process but also reduces risk while aligning with stringent international regulatory requirements set by authorities such as the FDA, EMA, and ICH. These frameworks represent the gold standard for proactive quality management in pharmaceuticals starting from new drug development – ensuring robust processes that meet global expectations.”
CEO of GM PHARMA, Levan Varduashvili Continues:
“The integration of DoE–QbD principles represents a significant advancement for GM PHARMA’s R&D function. As one of the most regulated and technologically advanced industries, pharmaceutical company demands continuous improvement and unwavering standards. Continuous training initiatives like this seminar for R&D reaffirm our commitment to innovation, regulatory excellence, and delivering high-quality pharmaceutical products worldwide.”
It should be emphasized that GM PHARMA, an international multinational pharmaceutical company, operates a state-of-the-art manufacturing plant in Tbilisi, supported by a 25-year history of continuous development. The facility continues to stand out as the only manufacturing site in Georgia with a full technological cycle for the production of solid dosage forms and remains one of the most advanced pharmaceutical manufacturers in the South Caucasus region.
The company holds all essential national and international certifications, permits, and licenses required for pharmaceutical manufacturing—including the Georgian national GMP certificate, the international PIC/S GMP certification, ISO 9001:2017, ISO 17025, and others.
A quarter of a century after its establishment, GM PHARMA continues to pursue ambitious goals—its current top priority is obtaining the European Union Good Manufacturing Practice (EU GMP) certification. This milestone will underscore the company’s commitment to the highest standards of quality and serve as a critical enabler for expansion into new markets. GM PHARMA is planning to initiate operations in EU member states, Southeast Asia, and Latin and Central America, supporting its long-term strategic growth objectives and strengthening its position within the global pharmaceutical industry.
Since its foundation, the company’s core values have remained unchanged – the development and delivery of pharmaceutical products that enhance patients’ quality of life and extend longevity.
GM PHARMA – Serving those who need it most!
