21 CFR PART 111

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In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111. In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations. The move was in response to concerns about substandard dietary supplement manufacturing practices, as well as mislabeling practices.

The 21 CFR 111 ruling addresses the quality of the manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers’ access to dietary supplements; nor does it address the safety of the dietary supplement’s ingredients, or their effects on health, when proper manufacturing techniques are used. The rule applies to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.

21 CFR Part 111 Requirements

21 CFR Part 111 – Sections 111.103 & 111.105 of subpart F
Under sec. 111.103 of subpart F, you must establish and follow written procedures for the responsibilities of quality control operations; these include written procedures for conducting a material review and making a disposition decision and for approving or rejecting any reprocessing. Under sec. 111.105 of subpart F, quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement. Furthermore, the dietary supplement must be packaged and labeled as specified in the master manufacturing record.

21 CFR Part 111 – Sections 111.12(c), 111.13 & 111.14(b) of subpart B
Under sec. 111.12(c) of subpart B, each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operation, must have the education, training, or experience to perform the person’s assigned functions. In addition (under sec. 111.13 of subpart B), qualified personnel must be assigned to supervise the manufacturing, packaging, labeling, or holding of dietary supplements, and each supervisor must be qualified by education, training, or experience to supervise. Under sec. 111.14(b) of subpart B, you must make and keep the following records: written procedures for fulfilling the requirements of subpart B; and documentation of training, including the date of the training, the type of training, and the person(s) trained.

21 CFR Part 111 – Section 111.70(a) & sec. 111.70(c)2 of subpart E
Under sec. 111.70(a) of subpart E, you must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Under Sec 111.70(c)2 of subpart E, you must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplement and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement.

21 CFR Part 111 – Section 111.570(b)2(ii) of subpart O
Written records of product complaints must be kept and must include the (A) the name and description of the dietary supplement; (B) the batch, lot, or control number of the dietary supplement, if available; (C) the date the complaint was received and the name, address, or telephone number of the complainant, if available; (D) the nature of the complaint including, if known, how the product was used; (E) the reply to the complainant, if any; and (F) findings of the investigation and follow-up action taken when an investigation is performed.

21 CFR Part 111 – Section 111.75 (i) of subpart E and Section 111.530 of subpart N Under sec. 111.75 (i) of subpart E
You must establish corrective action plans when an established specification is not met. Furthermore (under 111.530 of subpart N), if a dietary supplement is returned and the reason for the return implicates other batches, you must conduct an investigation of your manufacturing processes on each of those other batches to determine compliance with specifications.

21 CFR Part 111 – Section 111.120(b) of subpart F
According to sec. 111.120(b) of subpart F, the quality control operations team must determine whether dietary supplement components, packaging, and labels conform to specifications established under sec. 111.70 (b) and (d) of Part E (which establishes component, labeling, and packaging specifications for ensuring the quality of a dietary supplement).