Regulatory Status and Excipient Quality

According to ICH Guideline Q8 Pharmaceutical Development, the marketing authorization application (MAA) should discuss the excipients chosen and their concentration. The MAA should show the characteristics that can influence the medical product performance and manufacturability relative to the respective function of each excipient. Additionally, the MAA should demonstrate the ability of excipients to provide their intended functionality throughout the intended period of validity of the formulation. Use the information on excipient performance as appropriate to justify the choice and quality attributes of the excipients.26 

Excipient and vendor selections can greatly influence the new drag development timeline, product performance, and acceptance of final products. Compendial excipients have composition consistent with monographs published in compendia such as USP-NF these are the better-characterized excipients. These excipients most likely possess desirable qualities and are preferred excipients for pharmaceutical formulations. Non-compendial excipients can also be used for drug products if they are supported by Type IV dmg master files (DMFs) in regulatory dossiers. Overall, a good excipient supplier should 29 

Control of excipients is often built around the various pharmacopeial standards including the British Pharmacopoeia (BP), European Pharmacopoeia (PhEur), Japanese Pharmacopeia (JP) and the United States Pharmacopeia/National Formulary (USP/NF). The use of excipients that conform to a compendium ensures that the material meets the established specifications and acceptance criteria. This provides a handle on the batch-to-batch variability of the excipients used, as well as an option to select from multiple vendors for controlling the cost of goods. However, the pharmaceutical industry has long recognized that these standards are 

Very few excipients are manufactured specifically for pharmaceutical use. Manufacturing plants are usually not devoted to the manufacture of a specific excipient. With continuous production cycles, the control and quality are often not at a 

Microbial limit Microbial limit Acidity and alkalinity 

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