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62 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Quality knowledge about the interaction between material at- tributes and process parameters with product quality attributes. For instance, unexpected results might be observed when changes in raw material quality are implemented, even within the approved specifica- tions. For example, slight changes in the particle size of excipients may impact the compression behavior of a dry mix for direct compression or slightly increased amounts of peroxides in raw materials may lead to significant variations in the degradation rate of the active ingredient in the formulation. Also, changes in production technology, usually made to improve not only productivity but quality reproducibility as well, can lead to an unexpected adverse impact on product quality. This may happen, for example, when moving from conventional granulation to high-speed or fluid- bed granulation in solid oral dosage forms production or from low-shear mixing to high-shear homogeniza- tion in creams manufacturing. All these cases, while potentially negatively affecting product quality or sta- bility, lead to an increased understanding of products and related processes and are typically captured in the adaptation of materials specifications or manufactur- ing methods, in other words, in the revision of critical materials attributes and critical process parameters. Knowledge is frequently acquired externally. This is the case, for instance, of attendance to courses, meetings, and symposia organized by academic, professional, industry, or health authorities, orga- nizations, or associations. Other opportunities to gain new information and understanding of prod- ucts and processes are the interaction with materials, equipment, or instrument suppliers, with providers of special good manufacturing practice (GMP) ser- Figure 2. Collaboration is at the heart of pharmaceutical development. Blue and yellow circles outline intra-pharmaceutical development interactions and inter functions interactions, respectively. ADME is absorption, distribution, metabolism, and excretion; QA is quality assurance; R&D is research and development. ADME QA Corporate Marketing Toxicology Operations Regulatory affairs Clinical team Pre- formulation QA R&D Formulation development Clinical supply Analytical development Stability Discovery Documentation Figure 2. Collaboration is at the heart of pharmaceutical development. Blue and yellow circles outline intra- pharmaceutical development interactions and inter functions interactions, respectively. ADME is absorption, distribution, metabolism, and excretion; QA is quality assurance; R&D is research and development.