USP <1163> - Quality Assurance in Pharmaceutical Compounding

What it says

General Chapter <1163> provides quality assurance principles for pharmaceutical compounding, addressing verification of ingredient identity and quality, process and equipment controls, personnel training and competency, and documentation practices supporting the quality of compounded preparations across both sterile and nonsterile compounding.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This chapter provides the overarching quality assurance framework that chapters <795> for nonsterile compounding and <797> for sterile compounding operate within, addressing the quality system principles common to both rather than the specific technical requirements unique to each.
• Ingredient verification takes on particular importance in compounding, where components are often sourced differently than in commercial manufacturing, requiring specific attention to confirming identity and quality before use.
• Documentation practices described in this chapter parallel core GMP documentation principles, contemporaneous records, traceability and review, applied specifically to the compounding pharmacy context.

What inspectors look for

• Whether ingredient verification processes genuinely confirm identity and quality before compounding, rather than relying on supplier documentation alone without independent verification.
• Whether personnel competency for compounding activities is documented and current, consistent with broader personnel qualification principles.
• Whether compounding records provide genuine traceability connecting specific preparations to the ingredients, equipment and personnel involved.

Related regulations