C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS › Subpart K—Production and Process Control System: Requirements for Manufacturing Operations

21 C.F.R. § 111.355

What are the design requirements for manufacturing operations?

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You must design or select manufacturing processes to ensure that product specifications are consistently met.