Current Good Manufacturing Practices (cGMPs)

One important outcome of choosing to market a product of yours as a dietary supplement or cosmetic is that certain Current Good Manufacturing Practices (cGMPs) must be followed. You might already be familiar with the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) that governs field production and post-harvest packing.

And, if you make any value-added food products, you might also already know that additional food safety rules are triggered once you start processing on or off farm. There are very few things you can do on-farm without having to establish a cGMP program.

You can dehydrate, label, and pack whole raw agricultural products on farm without having to establish a cGMP program. So, if you are growing herbs to sell in their whole form for teas or for others to process into products, you will not have to establish a dietary supplement cGMP program.

But what if you do need to follow cGMPs for dietary supplements or cosmetics? What are you getting yourself into?

There are a lot of very basic requirements that have to do with having a sanitary and health staff, building and equipment. These things might take some thinking, planning, and small changes to your lab or the equipment you use (for example, wood is not considered sanitizable and should not be used in a production facility). The most burdensome part of the process will be 1) convincing yourself these steps are worth the time and effort by understanding the ideas and theories behind them, and 2) the recordkeeping!

Unlike food production cGMPs, there are very few exceptions to the dietary supplement and cosmetic cGMPs. There is, for example, no exception or a small business. There is an exemption if you are only selling wholesale. And, if you are an herbalist who advises individual clients and makes specific products for that individual, you are less likely to see FDA enforcement based on cGMPs. Even then, though, it isn’t impossible.

Establishing a cGMP program is a good idea for almost anyone producing dietary supplements or cosmetics. It requires appointing at least one quality control manager and developing extensive plans and recordkeeping procedures. The cGMPs must become a routine aspect of your operation, as all inspectors live by the motto, “if it isn’t written down, it didn’t happen!” To establish a cGMP program, the quality supervisor is required to get training. Look for training programs that supply templates for procedures and recordkeeping. If you can find such a program, you will save yourself a lot of headaches! This guide will not cover cGMPs extensively but see the chart on the next page for an overview of what each section of the rules requires.

SELECTED OVERVIEW OF cGMPs FOR DIETARY SUPPLEMENTS (capsules, tinctures)

Personnel, Physical Building and Grounds, Equipment

Selected Rules:

  • All employees must be well, clean, and practice appropriate hygiene while preparing products
  • Lab must be kept clean and in good repair, water must be potable, cleaners and sanitizers must be approved for their intended use
  • The flow through the lab must support cleanliness (avoid cross-contamination)
  • Equipment must be sanitizable and not create crevices where things can collect
  • Equipment must be calibrated, maintained and inspected routinely

Selected Recordkeeping Requirements:

  • Cleaning, sanitizing and maintenance procedures must be in writing and logged
  • All staff must be trained in health and safety and water testing must be on file
  • Equipment that must be calibrated must have records of these steps

Manufacturing Process

Selected Rules:

  • Develop specification for quality product, and verify that all product meets those standards
  • Must keep records to show that the product comes from your fields or have proof of the identity of product you buy in

Selected Recordkeeping Requirements:

  • Create a Master Manufacturing Record (MMR) that holds the specifications for your products
  • Create a batch production record for each batch created, and that it complies with the MMR

Distribution

Selected Rules:

  • Must have some way to trace your sales, not necessarily a lot number
  • Must pack and hold the product in conditions that keep that product safe (does it need refrigeration?)
  • Hold reserve samples of each batch for two years from date of distribution
  • Must have a process for receiving returned product, quarantining if needed and responding to customer complaints

Selected Recordkeeping Requirements:

  • Sales records–a process for tracking where certain batches were distributed

OVERVIEW OF COSMETIC cGMPs (lotions, lip balms, etc…)

Personnel, Physical Building and Grounds, Equipment

Selected Rules

  • All employees must be well, clean, and practice appropriate hygiene while preparing products
  • Lab must be kept clean and in good repair, water must be potable, cleaners and sanitizers must be approved for their intended use
  • The flow through the lab must support cleanliness (avoid cross-contamination)
  • Equipment must be sanitizable and not create crevices where things can collect
  • Equipment must be calibrated, maintained and inspected routinely

Selected Recordkeeping Requirements

  • Cleaning, sanitizing and maintenance procedures must be in writing and logged
  • All staff must be trained in health and safety and water testing must be on file
  • Equipment that must be calibrated must have records of these steps

Manufacturing Process

Selected Rules

  • Have a process to verify incoming materials, store them to protect them from contamination
  • Write down formulations for each product made and keep records to demonstrate that batches adhere to these formulations

Selected Recordkeeping Requirements

  • Create a batch production record for each batch created, and that it complies with the formulations laid out before manufacture

Distribution

Selected Rules

  • Ensure label complies with the law
  • Have a written procedure to deal with customer complaints and receive rejected product

Selected Recordkeeping Requirements

  • Sales records–a process for tracking where certain batches were distributed

Action Steps for the Botanical Producer

The information in this guide is just a basic overview of the Current Good Manufacturing Practices for dietary supplements and cosmetics. Some good next steps for the botanical producer trying to determine how to comply with safety and health regulations are:

  • Consult with a food safety expert through Extension or some other organization to determine if the products you are making will be regulated as food (such as only dehydrating herbs you’ve grown on the farm), dietary supplements, or cosmetics. Remember that the health-related claims you make about your products will also determine whether they are considered food (some teas are marketed and regulated as foods) or dietary supplements (many teas are marketed and regulated as dietary supplements).
  • Work your network to find other botanical producers that have completed a cGMP plan and ask if they would share the plan or at least talk to you about compliance.
  • Search for herbalist guilds or producer associations that provide cGMP training. Ask if templates for recordkeeping come with the training!

Ultimately, the Action Steps for this chapter are:

  • To call the state’s food program to determine who would inspect the production of the dietary supplement or cosmetic. In some cases, this would be the food safety program through the Department of Agriculture, the county health department, or other state officials. You will need to describe the product you want to make to determine which agency will oversee your production. An Extension Agent might be a good intermediary to help you through this system.
  • Create a Good Manufacturing Practices Safety Plan and Recordkeeping system that is specific to the dietary supplements and/or cosmetics the producer is creating.