Batch Records
The Batch Record is a checklist and summary of all the actions were actually done when producing a batch of product based on a Master Formula. The checklist itself should be based on a Master Formula, updated if the Master Formula is updated, and always kept absolutely current.
If the whole process of making the product is carried out in stages with time in between, then the batch record should be broken into several parts so that one can be finished completely during one production period. Cold process soap is an example where you might have a batch record broken out into several parts such as making of the soap and pouring it into molds, unmolding and cutting, and then trimming and packaging.
Purpose
The purpose of the batch record is to have a accurate documentation for each batch of product you produce and to provide a checklist that can be completed at the time of manufacture to make sure that each step is correctly completed.
After the fact, the batch record gives you a record you can go to if there is any problem with thee product. Looking at the batch record you should be able to tell what ingredients were used (and from what supplier) and spot any issues that may have occurred during the manufacturing.
If you have employees or helpers, it will tell you who worked on the batch at each stage.
Batch Numbers
A batch number is a unique identifier assigned to a product batch in order to track it. You assign the batch number when you make the product.
You should have a system for creating your batch numbers. There is no required format, but they are usually somehow related to the product and the date of manufacture. It needs to be something that you can work with and easily track.
One way to do it is just sequential numbers. 00001, 00002, 00003, etc. The issue with that is in order to know what it is and when it was made you would have to keep a log book that refers the number back to a description of the batch.
Another way is to use the date with a sequential number: 202406301, 202406302, etc. This tells you the date just on looking at it, but you would still need a log to determine what the product was.
An easier way is to use a combination of letters and numbers (alphanumeric) that make it easy for you to see what it is. Something like CR-LAV-20240630 is easy to translate into Lavender (LAV) Cream (CR) made on June 30, 2024. If you made two batches of lavender cream that day, you could assign CR-LAV-20240630-A, CR-LAV-20240630-B.
Content
The content of the Batch Record must be complete and allow for documentation of every step along the way. The following information should be included:
Document Information
The top of the first page of the Batch Record should clearly show the name of the product being produced, master formula being used, date, and the assigned batch number.
Subsequent pages need sufficient information so they can be identified if they are separated from the first page.
Batch Size
Master Formulas are normally in terms of percentages of ingredients. The batch record needs to show the total amount of product being produced and the final number of finished units (bottles, jars, bars, etc.) being made.
Besides being important information, it can also be used as a side-check to make sure that all ingredients have been added. If you’re supposed to end up with 65 ounces of lotion and you only have 55 when you’re done, then something was missed.
Ingredients
A list of the ingredients and the required amounts must be in the batch records.
For each ingredient there needs to be a check-off that it was, in fact, measured correctly and added to the batch. Large companies often have a second person check and sign-off on the ingredient measuring.
When full GMP is in place, ingredients are tracked when they are received and assigned lot numbers. If this is in place, the lot number of the ingredient should be added to the batch record. If you aren’t yet tracking lot numbers, then the supplier from whom the ingredient was purchased should be listed. That way if there is any issue later on, you’ll know who you got the ingredients from and can track down any issues. It’s also handy if an ingredient from one supplier worked better than a similar ingredient from a different supplier.
Checklist
Each step of the process should have a place to be checked off or initialed to indicate it was done as stated. For example, if the ingredients are supposed to be mixed for a specific amount of time that would be one item on the checklist and have a place to sign off that it was done.
The checklist can also include verification steps. For example, if the ingredients are supposed to be heated to a specific temperature it would be a step on the checklist but would also have a place to write in the actual temperature that was taken to verify the step was completed.
Product Label
Attaching a copy of the actual product label to the Batch Record can be helpful, particularly if you have several different labels for a single product. It is highly recommended to do so.
Product Sample
For finished, packaged products, most GMP Guidelines suggest one completed unit in the finished packaging be held as a "retain sample." However, if you are making very small batches, that could be unreasonable. In that case, consider setting aside a small amount (such as a piece of a bar of soap or an ounce of cream or lotion).
The Batch Record should have a place to indicate what sample was retained and where it is stored.
Record Keeping
The original batch record should be kept. Do not rewrite the batch record – keep the original regardless of how messy it might be. You can file it in a file folder or binder, but keep thee records in order in some way so you can find them when needed.
If you are keeping your records digitally, you can scan the original batch record and keep that file for your records. Be sure to suitably name the file so you can find it again (the batch number is a good way) and have a reliable file folder system on your computer.
A log, which just lists the date, batch number, product and quantity is a nice record to have if you want to be able to easily scan down a list of the product batches you’ve made or find something made some time ago. If you’re going paperless, the log can be easily kept in a spreadsheet and even link to the batch files on your computer.
Of course, if you are keeping digital files keep back-ups! Ideally, you should have back-ups of all your records somewhere off-site or in the cloud, and preferably in two or more locations. Better safe than sorry.
