21 CFR 211.111 - Time Limits on Production

What it says

When appropriate, time limits for the completion of each phase of production must be established to assure the quality of the drug product. Deviation from an established time limit may be acceptable if it does not compromise the quality of the drug product, and any deviation must be justified and documented.

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

What it means in practice

• Hold times between steps, such as how long a bulk solution can wait before filling, are common examples, and the limit should be supported by data.
• The phrase when appropriate means the firm decides where limits are needed, but it must be able to explain those decisions.
• Exceeding a limit is handled through the deviation system, with a documented justification and impact assessment.

What FDA inspectors look for

• Whether time limits exist for production phases where time could affect quality.
• Whether limits are supported by hold-time studies or other data.
• Whether exceedances were justified and documented.

Related regulations