21 CFR 211.115 - Reprocessing

What it says

Written procedures must describe the circumstances and manner in which reprocessing of a batch that does not conform to standards or specifications may occur, and reprocessed batches must be examined and tested to demonstrate they meet all applicable standards, specifications and characteristics before disposition.

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

What it means in practice

• Reprocessing is a formally controlled activity requiring its own written procedure and justification, not an ad hoc response to an out-of-specification result applied at the discretion of production personnel.
• A reprocessed batch is expected to demonstrate it meets the same standards as any other batch, with testing scoped to actually confirm this rather than assumed based on the reprocessing method having worked previously.
• This provision is distinct from routine in-process adjustments; reprocessing specifically addresses material that has already failed to conform to standards and is being brought back into conformance through additional processing.

What FDA inspectors look for

• Whether reprocessing is governed by a specific written procedure defining when it is permitted and how it must be documented, rather than handled informally.
• Whether reprocessed batches undergo testing genuinely scoped to confirm the specific quality attributes affected by the original nonconformance.
• Whether reprocessing is used as an infrequent, justified exception rather than a routine, expected part of the manufacturing process for a given product.

Related regulations