21 CFR 211.167 - Special Testing Requirements

What it says

For each batch of drug product purporting to be sterile or pyrogen-free, appropriate laboratory testing must be conducted, and written procedures for the validation of sterilization processes and for other special testing needs must be established and followed, with additional provisions covering ophthalmic ointments, controlled-release products and certain other product types.

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

What it means in practice

• This provision is the CGMP anchor for batch-level sterility and pyrogen or endotoxin testing, alongside the process-level assurance that validation provides.
• Testing under this provision is one part of sterility assurance and does not replace validated sterilization and aseptic processes.
• Product-specific requirements, such as for controlled-release dosage forms, mean the testing program has to reflect the actual product type.

What FDA inspectors look for

• Whether each batch of a product labeled sterile or pyrogen-free is tested as the written procedures require.
• Whether the test methods used are validated and suitable for the specific product.
• Whether investigations are opened and completed when a sterility or endotoxin result fails or is invalidated.

Related regulations