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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.111]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F – Production and Process Controls
Sec. 211.111 Time limitations on production.
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.
As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.
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