Shelley's Place

Good Manufacturing Practices

US Manufacturing Dietary Supplement Current Good Manufacturing Practices Regulation

Shelley’s Place Founder, ShelleyRae, personally oversees our GMP clients.

ShelleyRae has 10 years of GMP experience in nutraceuticals and 30 years experience in GMP overall; including supporting the original writer of many of the aeronautical ANSI and other standards.

We offer our clients expert support in understanding the manufacturing, packaging, labeling, and licensing requirements of the FDA and Health Canada. Including general compliance and recall procedures.

US Manufacturing

Dietary Supplement Current Good Manufacturing Practices

Regulation (21 CFR part 111) entitled Current Good Manufacturing Practice (CGMP) In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements (72 FR 34752). The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure    that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

          Supporting All Subparts of the DS CGMP Rules

Including Requirements for Written Procedures

 

              B  Fulfilling the requirements for personnel (21 CFR 111.8)

C      Cleaning the physical plant and pest control (21 CFR 111.16)

D      Fulfilling the requirements for equipment and utensils, including calibrating instruments and controls you use in manufacturing or testing a component or dietary supplement; calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements (21 CFR 111.25)

F       The responsibilities of quality control personnel, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing (21 CFR 111.103)

G      Fulfilling the requirements for components, packaging, and labels and for product that you receive for packaging or labeling as a dietary supplement (21 CFR 111.153)

J      Laboratory operations, including written procedures for the tests and examinations you conduct to determine whether specifications are met (21 CFR 111.303)

K      Manufacturing operations (21 CFR 111.353)

L       Packaging and labeling operations (21 CFR 111.403)

M     Holding and distributing operations (21 CFR 111.453)

N      Fulfilling the requirements for returned dietary supplements (21 CFR 111.503)

O      Fulfilling the requirements for product complaints (21 CFR 111.553)

Audit Supervision and Review

         Vendor Required

         GMPS Required

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