USP <1078> - Good Manufacturing Practices for Bulk Pharmaceutical Excipients

What it says

This general information chapter describes good manufacturing practices for bulk pharmaceutical excipients, covering quality management, personnel, buildings and facilities, process equipment, documentation, materials management, production and in-process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints and recalls, and contract manufacturers.

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

What it means in practice

• Excipients are a large share of most dosage forms, so their quality affects the finished product.
• Drug manufacturers rely on excipient suppliers, which makes supplier qualification a key part of the drug quality system.
• Excipient GMP is guidance rather than a drug-style regulation, so how it is applied depends on the supplier's quality system and the customer's expectations.

What inspectors look for

• Whether excipient suppliers are qualified and their quality is checked.
• Whether incoming excipients are tested or verified before use.
• Whether supplier changes are communicated and assessed.

Related regulations