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A guide to the new dietary supplement GMPs: reviewing the details, nuances and potential impact of the new rule.

On June 25, 2007, the Food and Drug Administration (FDA) published the dietary supplement current good manufacturing practices (cGMPs) final rule. The new regulations apply to all persons who manufacture, package, label, or hold dietary supplements, with the exception of persons who hold dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual customers. A warehouse or other storage facility for a retailer does not qualify as a retail establishment and is subject to the rule. Similarly, a warehouse or other storage facility that sells directly to individual consumers does not qualify as a retail establishment and is subject to the rule. Dietary supplements that are imported are also subject to the rule. While traditional retailers do not technically fall under the rule, as discussed later in this article, the new regulations raise many issues that retailers should consider.

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According to FDA, the cGMPs are intended to establish a comprehensive system of process controls, including documentation of each stage of the manufacturing process, which can minimize the likelihood of, or detect problems and variances in manufacturing as they occur, before the product is in its finished form. The process controls that are a part of cGMPs are essential to ensure that a dietary supplement is manufactured, packaged, held, and labeled in a consistent and reproducible manner.

Compliance Dates

The compliance date for businesses that employ fewer than 20 full-time equivalent employees is 36 months from the publication of the final rule (June 25, 2010). The compliance date for businesses employing fewer than 500 but 20 or more full-time equivalent employees is 24 months from the date of the final rule (June 25, 2009). And the compliance date for businesses employing 500 or more full-time equivalent employees is 12 months from the date of the final rule (June 25, 2008). However, due to the broad nature of the new requirements, it is recommended that companies begin to consider how they will implement some of the requirements now.

Summary of Major Requirements

The requirements of the rule apply to companies based on the functions that the company is performing. Keep in mind, one person or company will often perform multiple functions, and thus, the requirements under multiple sections would apply to that person or company. What follows is a list of general requirements by function.

Holders or Distributors. Applicable to holders or distributors, the final rule, among other things:

* Establishes minimum requirements for personnel, including hygienic practices and qualifications;

* Establishes minimum requirements for the physical plant and grounds, including (but not limited to) waste removal, grass cutting, maintenance of roads and parking lots, cleaning and sanitizing agents, pest control, water supply, plumbing, plant size, ventilation, temperature and humidity controls and lighting;

* Establishes minimum requirements for equipment and utensils, including equipment calibration, utensil and equipment design and sanitation;

* Imposes certain requirements on automatic, mechanical or electronic equipment used to hold a dietary supplement;

* Requires the establishment and use of written procedures for most operations--including those related to quality control and product complaints;

* Requires implementation of quality control operations to ensure the quality of a dietary supplement;

* Requires establishment of specifications for any point, step, or stage in the process where control is necessary to ensure the quality of the dietary supplement (e.g., a person would need to establish a specification for the temperature at which the product will be held);

* Requires that you hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute in a manner that protects against contamination and deterioration;

* Requires records associated with holding or distribution of a dietary supplement to be kept for one year beyond the shelf life dating, or if shelf life dating is not used, for two years beyond the date of distribution of the last batch of dietary supplements associated with those records;

* Requires identification and quarantine of returned dietary supplements until quality control personnel conduct a material review and make a disposition decision;

* Requires quality control personnel to conduct a material review and make a disposition decision under certain circumstances; and

* Requires a qualified person to investigate any "product complaint" that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.

If a company's only function is to hold packaged and labeled dietary supplements for distribution and the company's name and address do not appear on the label, the company is not required to establish component specifications, in-process specifications, specifications for labels and for packaging, product specifications, specifications for product received from a supplier for packaging as a dietary supplement (and for distribution rather than for return to the supplier), or specifications for the packaging and labeling of the finished packaged and labeled dietary supplements because the company does not engage in any of those activities.

However, many distributors of dietary supplements are private label distributors, meaning that the company's name appears on the product label. Under the new cGMPs, there are additional requirements for those distributors who are private label distributors. Private label distributors must know what and how manufacturing activities are performed, so they can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution. The easiest way for most companies to satisfy that requirement will be to obtain certificates of analysis (CoAs) from the manufacturer. However, the regulations include additional requirements for CoAs. Up until now, many companies would just accept CoAs at face value. Now, however, FDA is requiring that companies first qualify the supplier or manufacturer by establishing the reliability of the CoAs; maintain documentation of how the company qualified the supplier or manufacturer; and periodically re-confirm the supplier's or manufacturer's CoAs.

In addition to the new adverse event reporting (AER) requirements for dietary supplements, which go into effect on December 22, 2007, the cGMPs add additional requirements related to complaints. For example, the regulations require that holders of dietary supplements review and investigate all product complaints they receive to determine whether the complaint relates to a failure of the processes under the distributor's control that could affect the identity, purity, strength or composition of the supplement. Thus, for example, holders/distributors of dietary supplements must investigate the conditions of temperature, humidity and light in which the supplement was held. If the distributor concludes that the problem is unrelated to any process under control of the distributor, the distributor should contact the manufacturer.

Packagers and Labelers. Applicable to packagers and labelers, the final rule, among other things:

* Establishes minimum requirements for personnel, including hygienic practices and qualifications;

* Establishes minimum requirements for the physical plant and grounds, including (but not limited to) waste removal, grass cutting, maintenance of roads and parking lots, cleaning and sanitizing agents, pest control, water supply, plumbing, plant size, ventilation, temperature and humidity controls and lighting;

* Establishes minimum requirements for equipment and utensils, including equipment calibration, utensil and equipment design and sanitation;

* Requires that the physical plant have separate or defined areas for packaging and labeling operations;

* Imposes certain requirements on automatic, mechanical or electronic equipment used to package or label a dietary supplement;

* Requires the establishment and use of written procedures for most operations--including those related to equipment, physical plant sanitation, quality control, packaging and labeling and product complaints;

* Requires the implementation of a system of production and process controls that cover all stages of labeling dietary supplements;

-Requires the establishment of specifications for any point, step or stage in the in product production that will ensure dietary supplements meet the identity, purity, strength, and composition established in specifications and are properly packaged and labeled as specified in the master manufacturing record (e.g., if you receive a product from a supplier for packaging or labeling as a dietary supplement, you need to establish a specification to ensure that the product that you receive is adequately identified and is consistent with your purchase order);

* Requires the establishment of specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements; packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement;

* Requires implementation of a quality control unit to ensure, among other things, that the labeling operations are performed in a manner that prevents adulteration and misbranding;

* Requires that companies clearly identify, hold, and control under a quarantine system for appropriate disposition any packaged and labeled dietary supplement that is rejected for distribution;

* Provides that a company may repackage or re-label dietary supplements only after quality control personnel have approved such re-packaging or re-labeling;

* Requires that a company examine a representative sample of each batch of repackaged or re-labeled dietary supplements to determine whether the repackaged or re-labeled dietary supplements meet all specifications;

* Requires that quality control personnel approve or reject each batch of repackaged or re-labeled dietary supplement prior to its release for distribution

* Requires records associated with packaging and labeling of a dietary supplement to be kept for one year beyond the shelf life dating, or if shelf life dating is not used, for two years beyond the date of distribution of the last batch of dietary supplements associated with those records; and

* Requires a qualified person to investigate any "product complaint" that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.

A packager/labeler does not need to conduct testing on a finished batch of dietary supplements since it does not manufacture the finished batch of dietary supplements. A packager or labeler also does not need to do any required component testing because the packager or labeler does not receive components, rather it receives a finished dietary supplement. If you only label products and do not package, you do not need to include an accurate statement of the weight or measure of each component to be used because you are starting from packages already filled.

Manufacturers. Applicable to manufacturers, the final rule, among other things:

* Establishes minimum requirements for personnel, including hygienic practices and qualifications;

* Establishes minimum requirements for the physical plant and grounds, including (but not limited to) waste removal, grass cutting, maintenance of roads and parking lots, cleaning and sanitizing agents, pest control, water supply, plumbing, plant size, ventilation, temperature and humidity controls and lighting;

* Establishes minimum requirements for equipment and utensils, including equipment calibration, utensil and equipment design and sanitation;

* Imposes certain requirements on automatic, mechanical or electronic equipment used to manufacture a dietary supplement;

* Requires the establishment and use of written procedures for most operations--including those related to equipment, physical plant sanitation, certain manufacturing operations, quality control, laboratory testing and product complaints;

* Requires the preparation and use of a written master manufacturing record for each unique formulation of manufactured dietary supplement, and for each batch size, to ensure your manufacturing process is performed consistently and to ensure uniformity in the finished batch from batch to batch;

* Requires the establishment of process controls in order to produce a product consistently and reliably each time (e.g., there must be process controls in place to ensure that appropriate tests and examinations are conducted, a master manufacturing record is prepared, each batch production follows the master manufacturing record, and the finished tablet or capsule is placed in the intended package with the intended label);

* Requires the establishment of specifications for any point, step or stage in the product production that will ensure dietary supplements meet the identity, purity, strength and composition established in specifications and are properly packaged and labeled as specified in the master manufacturing record;

* Requires adequate documentation of the 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 supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement

* Requires implementation of quality control operations to ensure the quality of a dietary supplement;

* Requires the establishment and use of laboratory control processes related to establishing specifications and to the selection and use of testing and examination methods;

* Requires testing of a subset of finished batches of dietary supplements based on sound statistical sampling or, alternatively, testing all finished batches;

* Requires the preparation of a batch production record every time a dietary supplement batch is made; the batch production record must accurately follow the appropriate master manufacturing record;

* Requires the collection of representative samples of each unique lot of components and in-process materials for each manufactured batch, a subset of finished batches of each dietary supplement manufactured before releasing for distribution, and of each lot of packaged and labeled dietary supplements;

* Requires records associated with the manufacture of a dietary supplement to be kept for one year beyond the shelf life dating, or if shelf life dating is not used, for two years beyond the date of distribution of the last batch of dietary supplements associated with those records; and

* Requires a qualified person to investigate any "product complaint" that involves the possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.

The regulations also provide for the option to use a CoA (for specifications other than the identity of a dietary ingredient) from a component supplier instead of conducting tests or examinations on the components a manufacturer receives. However, the regulations include additional requirements for CoAs. In the past, many companies would just accept Co As at face value. Now, however, FDA is requiring that companies first qualify the supplier by establishing the reliability of the CoA; maintain documentation of how the company qualified the supplier; and periodically re-confirm the supplier's CoA.

Issues for Retailers to Consider

Even if a company functions only as a traditional retailer and does not perform any of the functions described in this article, the new rule raises issues to be considered. For example, given the new requirements placed on manufacturers, packagers and labelers, retailers should make certain that products they sell continue to be available. Retailers should also be proactive in investigating whether these new requirements are going to cause the price of the supplements they sell to increase.

If retailers have agreements with their suppliers, they may need to revise the agreements to ensure that the products are being manufactured, packaged, labeled and held in accordance with the new regulations. If they do not have agreements with their suppliers, retailers should consider whether it would be in their best interest to sign new agreements with them.

Summary

This article offers general descriptions of the new requirements. The regulations themselves are much more detailed. Nearly all sections of the new rule require that companies establish and follow written procedures. Thus, drafting standard operating procedures (SOPs) will be a key part of complying with the rule. Therefore, it would be wise to put together a checklist to ensure that the new requirements are being met.

About the author: Todd Harrison is a partner with the law firm Venable, which specializes in food and drug law, and is based in Washington, D.C. Mr. Harrison is also NUTRACEUTICALS WORLD'S Capitol Comments columnist. For more information on the new cGMPs or other regulatory issues, he can be reached at 202-344-4724; E-mail: taharrison@venable.com.

By Todd Harrison

Partner

Venable

Washington, D.C.

RELATED ARTICLE: This article in a nutshell:

* Compliance dates

* Summary of major requirements for holders/distributors, packers/labelers, manufacturers

* Issues for retailers to consider

* Summary
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Author:Harrison, Todd
Publication:Nutraceuticals World
Date:Sep 1, 2007
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