Keywords
Pharmaceutical manufacturing
Quality by Design (QbD)
Quality Risk Management (QRM)
Process validation
Abstract
Technology transfer (TT) in the pharmaceutical industry is a structured, lifecycle-oriented process that ensures the reproducible transition of products and processes from development to routine manufacturing. It should be understood not as a single event or documentation handover, but as an integrated system of knowledge transfer, process understanding, and organizational alignment within a GMP-regulated environment. This article provides a practical interpretation of TT based on key regulatory frameworks, including WHO, EMA, ICH Q8–Q12, FDA guidance, and PIC/S requirements. The study is based on analysis of regulatory documents, scientific literature, and industrial practice, supported by experience from GMP manufacturing environments. The objective is to translate regulatory expectations into operational principles that determine TT success. The results show that effective technology transfer depends on robust process knowledge, interdisciplinary collaboration, and consistent application of Quality by Design (QbD) and Quality Risk Management (QRM). Critical success factors include clear definition of critical process parameters (CPP) and critical quality attributes (CQA), effective analytical method transfer, and strong data integrity across sending and receiving units. Common failure modes include insufficient understanding of equipment differences, incomplete transfer of tacit knowledge, and inadequate control of material variability. Analytical transfer and scale-up are identified as particularly sensitive stages requiring strict operational control. Technology transfer is a strategic function within pharmaceutical quality systems that directly impacts product quality, regulatory compliance, and manufacturing robustness, while enabling efficient lifecycle management and reducing post-approval risks.
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