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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter B - Food for Human Consumption |
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Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements |
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Subpart E - Requirement to Establish a Production and Process Control System |
| § 111.55 - What are the requirements to implement a production and process control system? |
| § 111.60 - What are the design requirements for the production and process control system? |
| § 111.65 - What are the requirements for quality control operations? |
| § 111.70 - What specifications must you establish? |
| § 111.73 - What is your responsibility for determining whether established specifications are met? |
| § 111.75 - What must you do to determine whether specifications are met? |
| § 111.77 - What must you do if established specifications are not met? |
| § 111.80 - What representative samples must you collect? |
| § 111.83 - What are the requirements for reserve samples? |
| § 111.87 - Who conducts a material review and makes a disposition decision? |
| § 111.95 - Under this subpart E, what records must you make and keep? |