Keeping Batch Records for Herbal Products
About This Article
This article discusses the use of Manufacturing Batch Records for herbal products and supplements. It addresses the questions of what is a batch record, why are batch records important, and why would a manufacturer want to keep these records. The article also gives some suggested best practices for maintaining batch records for herbal products. Questions about this article can be directed to Team@BatchWize.com.
Article Contents:
Introduction
Batch Records for Herbal Products and The U.S. FDA
Best Practices for Maintaining Batch Records
What If I Don’t Create The Batch Record?
When to Get Help
Summary
1. Introduction
Making small amounts of herbal products for friends and family can be quite different than making herbal products on a large scale for commercial use. When deciding to make a product for sale, it is always a good idea to keep detailed records, also known as Batch Records or Manufacturing Batch Records. But what exactly is a Batch Record? Why is it important? And why would I need one? Let’s take a closer look.
2. Batch Records for Herbal Products and The U.S. FDA
The United States Food and Drug Administration (or U.S. FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
The FDA works to ensure that dietary supplements meet applicable safety standards and that they are well-manufactured and accurately labeled. The FDA is further responsible for enforcing the laws and regulations governing dietary supplements. (Reference: FDA Facts About Dietary Supplements)
Manufacturing Batch Records are typically used for herbal products and supplements, just as they are for any other type of product. These records serve several purposes, including:
Ensuring quality control over the herbal product
Documenting the production (or compounding) process
Providing traceability for raw materials that are used in the herbal product
Providing documentation for compliance to FDA regulations
Reducing the manufacturer’s liability
A gentle reminder that it is important to understand the classification of your product per the U.S. FDA. Generally Herbal Products (Dietary Supplements) are regulated as a food; but your product may also be regulated as a cosmetic, drug, medical device, or combination product depending on the product claims, intended use, and how the product is administered.
What is a Batch Record?
A “Batch Record” is the official record of the manufacturing process. In other words, it is the step by step directions a person follows to remake that tincture, salve, or supplement.
The Batch Record can include:
All the materials used to manufacture and package the product
Quantity of each material used and each finished product made
Source of each material
Step-by-step directions
Any procedures followed to make and package the product
Product sampling or testing that was conducted
Location of manufacture
Name of the persons performing the manufacturing or testing operations
and more!
Top 8 items to include in your Herbal Batch Record. These are things that every manufacturer should consider.
Let’s pretend that we are making a new herbal tea for the summer that is infused with hibiscus and peppermint (sounds refreshing). Our Batch Record for the team could include a list of the ingredients, the steps that we took to make or mix the tea, and identification of the person or persons who made the tea.
Once we have made the bulk tea, we would need to fill the individual bottles and ensure the proper labeling is affixed. The process of filling and labeling would also be included in the batch record. If we decided to do any sampling before we release our product (like checking for bacteria), we would include the sampling and testing in the Herbal Tea Batch Record.
A Batch Record may also be called a “Manufacturing Record,” “Manufacturing Batch Record,” “Project File,” or “Production Record.” When it comes to the quality of your product and U.S. FDA compliance, the content of the file is more important than its name.
Some companies may break the Batch Record into several parts. For example, a manufacturer may have a record for the bulk manufacture of the product, a separate record for the filling of the product into individual vials or containers, and a third record for the packaging and labeling. Using our example, this would mean one set of documents for making the bulk tea, another set for filling the glass bottle, and a third set of documents for the packaging and labeling. (See also: Types of Batch Records)
Whatever form your specific Batch Record takes, it is always easiest to have a single Batch Record File compiled at the end of manufacture that can be easily reviewed by the Quality Representative. Using our example, this would mean that all the individual records would be combined and reviewed by quality before shipping the herbal tea to our loyal customers.
Manufacturing Batch Records are important for ensuring the safety, efficacy, and quality of herbal products, as well as for meeting regulatory requirements set by authorities such as the FDA (Food and Drug Administration) or the equivalent regulatory body in another country. Since our imaginary herbal tea company is marketing and selling products in the United States, we will need to follow the requirements of the U.S. FDA.
Best Practices for Herbal Product Batch Records. It’s important to consider the content of your Batch Records as well as the storage and maintenance.
3. Best Practices for Herbal Product Batch Records
Now that you have a better understanding of what is included in the Batch Record, how do you ensure that you are properly maintaining it? This is not an all inclusive list, but here are several best practices for keeping Batch Records.
Secure Location: Ensure that your Batch Records are stored in a secure location. If your herbal Batch Records are hand written on paper, they should be stored in a fireproof cabinet. If your records are electronic, they should be stored in a secure location with routine backup and recovery activities.
Legible & Retrievable: Whether your records are handwritten or digital, it is important that they can be easily read and understood at a later date by a third party. For paper records, this means the use of an indelible pen (one that won’t smear or easily fade in the light). For your electronic records, this means the storage of the record, raw data, meta data, and audit trail. The Manufacturing Batch Record must be fully accessible at any time. For example, if the U.S. FDA chose to come in and inspect our herbal tea manufacturing facility, we would need to provide the records quickly, and they should be easy to read. We should also establish document retention times (how long we keep the records) that align with our regulatory requirements.
Documentation: Implement GDP, Good Documentation Practices. Good documentation practices ensure that records are legible, complete, and accurate. It also provides guidance on how to document raw data, annotate comments, make corrections, or cite investigations.
Training: Training is an important part of Batch Record maintenance. Manufacturers should provide comprehensive training to employees responsible for record-keeping tasks to ensure they understand the importance of accurate documentation and are able to use the record keeping systems. If the process is changed or the system is updated, employees should be retrained. In our hypothetical herbal tea manufacturing facility, we have 3 trained personnel who can perform the manufacturing activities. When the recipe is changed, these employees would need to be retrained. And that training should be documented.
Make Updates: As you adapt and improve your process, be sure to meticulously update your manufacturing documents. For example: When changing a process parameter or set point, you should also change the document version. “Soak and Mixing Procedure Ver 1.0” would be updated and released as, “Soak and Mixing Procedure Ver 2.0.”
Things don’t always go as planned: When you need to deviate from the approved procedure or Master Record, you should always document the deviation within the Batch Record. Additionally, if a quality investigation is needed, this investigation should be referenced or cited in the Batch Record and reviewed by the quality representative. For example, while making our herbal tea, we ran out of the hibiscus supplied by Third Eye Hibiscus Co. and had to switch to ginseng provided by New Way Hibiscus, a secondary supplier. The change would be documented in the Batch Record.
Conduct routine documentation reviews: The manufacturer should establish a process where you routinely review manufacturing procedures and records. Ensure that procedures are up to date and accurately reflect the existing process. Verify that Manufacturing Records are accurate and complete. If there are any discrepancies (things that don’t go as planned), address them immediately and document it as part of the Quality Record.
Create A Master Record: A best practice is to develop a “Master Batch Record” and then execute a Production Record (Batch Record) each time you manufacture the product. Think about it like having a master recipe, and then executing that recipe the same way each time. Having a Master Record standardizes the process and procedures and ensures product consistency. The Master Record sets out exactly how to make the product, what type of equipment or materials are used, times, speeds, criteria, etc. In the Production Record, the manufacturer documents exactly what was done on that day, what specific equipment was used, what lot of material was used, who performed the operation, etc. The Master Record and Production Record should both be controlled documents and have a version number to ensure the most recent, approved version is in use.
4. What If Another Company Is Creating My Batch Record?
Many companies that sell herbal products and supplements hire a contract manufacturer (CMO, Copacker, etc.) to manufacture or package their product. These same guidelines apply to contract manufacturers. Additionally, it is important for the brand holder to review the Batch Records for their products, even if they did not personally manufacture the product. The brand holder bears final responsibility for ensuring that only safe and effective products are placed on the market.
Using our previous example, even if we do not personally manufacture the herbal tea, we are still responsible for reviewing the Manufacturing Records and ensuring that our product and manufacturing process comply with FDA & product requirements. In other words, we can’t pay to have someone else take on that liability – the buck stops with us!
5. When to Get Help
Batch Records are an important part of the manufacturing process and support the quality of the product that you are selling. These records are a requirement of GMP and may be used in the future by employees, quality personnel, FDA, or other regulatory agencies. The time and expense associated with Batch Record Review may be mitigated by using third party reviewers. These reviewers are trained Quality Specialists that review all of the product data, Manufacturing Records, test data, packaging, labeling, etc to help ensure that only quality products are released to the marketplace.
6. Summary
Manufacturing Batch Records are an important part of making herbal products. The Manufacturing Record documents how the product was made, what materials were used, and provides traceability. Like a beautiful fern, Manufacturing Records are constantly growing and evolving. These records should be reviewed periodically to ensure they represent your current process.
Authors/Content Contributors
Rebecca Waterbury, Suthi Nagar, BatchWize, LLC. BatchWize is a specialty consulting group that focuses on the review of quality records and the release of FDA regulated products. BatchWize helps companies get quality products to market faster, and keep them there. Contact BatchWize today for a free consultation. Email us at: Team@BatchWize.com.
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