Excipient
The inactive ingredients in a drug — fillers, binders, disintegrants, lubricants, colours, flavours. Cumulatively they're 90%+ of most tablets, and they have their own GMP framework (IPEC-PQG / EXCiPACT).
Excipients are everything in a drug product that isn't the API: lactose, MCC, magnesium stearate, povidone, croscarmellose, talc, dyes, flavours, coatings. They are not inert in regulatory terms — identity, purity, particle-size distribution and microbial limits all matter.
IPEC's Joint Good Manufacturing Practices Guide and EXCiPACT certification cover excipient GMP. Pharmacopoeias (USP, Ph. Eur., JP) define the monographs. V5 treats excipients as fully traceable raw materials with CoA capture, identity test on receipt, and FEFO at dispense.
- IPEC-PQG
- USP-NF
Free trial, no credit card, onboard in days, not months.