21 C.F.R. § 211.111 Time limitations on production.
Title 21 - Food and Drugs
When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.
Title 21: Food and Drugs
PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F—Production and Process Controls
§ 211.111 Time limitations on production.
