FDA Draft Guidance for Industry Current Good Manufacturing Practice

In August of 2016 the FDA released Draft Guidance for Industry Current Good Manufacturing Practice.  I have written previously that AFIA submitted 13 pages of comments on the 36 page document and that I was reluctant to discuss this draft document because of some of the  things it contains.  It is a year later and the compliance deadline is upon us (September 2017) but the guidance is still in draft form! It does not look like anything will change so it is time to move on…

I will not attempt to discuss the entire guidance document. I encourage all of my readers to review the entire document in detail. Here is what the guidance says about subjects on my list of FAQ’s:

(bold italic text is direct from the guidance document.)

  • What kind of training do I need to do? The FDA is clear that training on CGMP’s is not intended to be “formal classes” but instead can be gained through experience and supervision. On the other hand training on employee health, hygiene and food safety must be clear and documented. They state “Training does not need to be specific to each person’s assigned duties, but rather should take into account the range of duties to decide the scope of training(s) and whether a single training would be appropriate for all individuals, or separate audience specific trainings would be more appropriate. The training may be provided by facility personnel, an external source, or a combination of both. Training may be provided by any reasonable means, for example, on the job, in a classroom setting, or online.” They further state the expectation that “most facilities will also provide some form of refresher training”.


  • The rule specifically says that “jewelry and other objects” must be prevented from falling to feed. What they mean by “other”?Examples of objects that could fall into the animal food, equipment, or containers include: pens, sunglasses, gloves, tools, keys, pocket knives, or cell phones. Personnel should consider whether items stored in outside pockets (such as shirt pockets) might be able to fall out during operations, and if so, remove these items or place them in a more secure pocket.


  • Many people ask: What do they mean by Utensils?Utensils may include items such as buckets, shovels, or scoops. Utensils and equipment should be maintained so that parts or pieces do not break or fall off and contaminate the animal food. The cleaning procedures necessary to prevent animal food adulteration may vary depending on the type of product being manufactured.”


  • What does “sanitation” mean in a feed mill? “…livestock animal food operations generally avoid the use of water and liquid cleaning compounds because they need to maintain dry surfaces to move grains, oilseeds, and other predominantly dry ingredients through mixing operations for dry finished products. Instead, livestock animal food operations may use dry cleaning methods such as scraping, sweeping, vacuuming, flushing, or sequencing.


  • Do I need to use an outside pest control company? The answer is no but…

The management of the establishment should develop a comprehensive pest control plan that includes regular monitoring for the presence of pests and measures to exclude pests, such as: blocking possible pest entry points (e.g., using screens, keeping doors and windows secured, caulking holes), using pest trapping devices, and cleaning to remove pest harborage or attractants. Using cats or other animals as a method of pest exclusion is not acceptable because their presence can also lead to the contamination of animal food.


  • Do I have to use food grade lubricant? Food-grade lubricants should be used when they can come into contact with the animal food or an animal food-contact surface.”

Editorial Summary: 21 CFD 507.25 defines the cGMP for Plant Operations. It’s brevity in the rule bothers me a great deal. In my experience in assisting Livestock Feed Mills with cGMP evaluation and implementation this cGMP is critical to the mitigation of hazards. Section F on page 21 – 27 addresses this cGMP and should be read by all in great detail.