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| [Code of Federal Regulations] |
| [Title 21, Volume 2] |
| [CITE: 21CFR111] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 G - Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
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Sec. 111.153 What are the requirements under this subpart G for written procedures?
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You must establish and follow written procedures for fulfilling the requirements of this subpart G.
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Sec. 111.155 What requirements apply to components of dietary supplements?
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(a) You must visually examine each immediate container or grouping of immediate containers in a shipment that you receive for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the components;
(b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment you receive to ensure the components are consistent with your purchase order;
(c) You must quarantine components before you use them in the manufacture of a dietary supplement until:
(1) You collect representative samples of each unique lot of components (and, for components that you receive, of each unique shipment, and of each unique lot within each unique shipment);
(2) Quality control personnel review and approve the results of any tests or examinations conducted on components; and
(3) Quality control personnel approve the components for use in the manufacture of a dietary supplement, including approval of any treatment (including in-process adjustments) of components to make them suitable for use in the manufacture of a dietary supplement, and releases them from quarantine.
(d)(1) You must identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement that you manufactured and distributed.
(2) You must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of components that you receive and any lot of components that you produce.
(e) You must hold components under conditions that will protect against contamination and deterioration, and avoid mixups.
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Sec. 111.160 What requirements apply to packaging and labels received?
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(a) You must visually examine each immediate container or grouping of immediate containers in a shipment for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the packaging and labels.
(b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment to ensure that the packaging or labels are consistent with your purchase order.
(c) You must quarantine packaging and labels before you use them in the manufacture of a dietary supplement until:
(1) You collect representative samples of each unique shipment, and of each unique lot within each unique shipment, of packaging and labels and, at a minimum, conduct a visual identification of the immediate containers and closures;
(2) Quality control personnel review and approve the results of any tests or examinations conducted on the packaging and labels; and
(3) Quality control personnel approve the packaging and labels for use in the manufacture of a dietary supplement and release them from quarantine.
(d)(1) You must identify each unique lot within each unique shipment of packaging and labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging and label, the status of the packaging and label (e.g., quarantined, approved, or rejected); and to the dietary supplement that you distributed; and
(2) You must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of packaging and labels.
(e) You must hold packaging and labels under conditions that will protect against contamination and deterioration, and avoid mixups.
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Sec. 111.165 What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?
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(a) You must visually examine each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product.
(b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment of the received product to ensure that the received product is consistent with your purchase order.
(c) You must quarantine the received product until:
(1) You collect representative samples of each unique shipment, and of each unique lot within each unique shipment, of received product;
(2) Quality control personnel review and approve the documentation to determine whether the received product meets the specifications that you established under § 111.70(f); and
(3) Quality control personnel approve the received product for packaging or labeling as a dietary supplement and release the received product from quarantine.
(d)(1) You must identify each unique lot within each unique shipment of received product in a manner that allows you to trace the lot to the supplier, the date received, the name of the received product, the status of the received product (e.g., quarantined, approved, or rejected), and to the product that you packaged or labeled and distributed as a dietary supplement.
(2) You must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of the received product.
(e) You must hold the received product under conditions that will protect against contamination and deterioration, and avoid mixups.
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Sec. 111.170 What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?
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You must clearly identify, hold, and control under a quarantine system for appropriate disposition any component, packaging, and label, and any product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), that is rejected and unsuitable for use in manufacturing, packaging, or labeling operations.
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Sec. 111.180 Under this subpart G, what records must you make and keep?
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(a) You must make and keep records required under this subpart G in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for fulfilling the requirements of this subpart.
(2) Receiving records (including records such as certificates of analysis, suppliers' invoices, and suppliers' guarantees) for components, packaging, and labels and for products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and
(3) Documentation that the requirements of this subpart were met.
(i) The person who performs the required operation must document, at the time of performance, that the required operation was performed.
(ii) The documentation must include:
(A) The date that the components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement were received;
(B) The initials of the person performing the required operation;
(C) The results of any tests or examinations conducted on components, packaging, or labels, and of any visual examination of product that you receive for packaging or labeling as a dietary supplement; and
(D) Any material review and disposition decision conducted on components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement.
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Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.
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