Good Manufacturing Practices – Part 3

In this 3rd installment, we’ll take a look at the records required to meet the standards required in the Good Manufacturing Practices Guidelines/Inspection Checklist.

Like I say about labeling, “It isn’t COMPLICATED, but it is DETAILED.”  If you have your raw materials correctly logged and labeled, and your recipe/formulation with the procedures written out (see Part 2), then you already have most of the information needed for your recordkeeping.  As an added bonus, if you have been calculating the cost of each ingredient when it comes in, you’ll also be able to track your exact cost for each batch and individual product.

7. Records.

Check whether control records are maintained of:

• Raw materials and primary packaging materials, documenting disposition of rejected materials.
• Manufacturing of batches, documenting the:
  1. Kinds, lots and quantities of material used.
  2. Processing, handling, transferring, holding and filling.
  3. Sampling, controlling, adjusting and reworking.
  4. Code marks of batches and finished products.
• Finished products, documenting sampling, individual laboratory controls, test results and control status.
• Distribution, documenting initial interstate shipment, code marks and consignees.

Discussion:

When your ingredients come in, you should already have checked to make sure they are correct and up to standard (by inspection, testing and/or supplier documentation).  Keep a log or binder with the information for each ingredient received.  I’ve found it easiest to keep a binder, and put the information for each ingredient received, with all the data about it on one page, and then place that in the binder.  The information should include the date ordered, invoice number, cost including shipping (from which you can calculate the cost per ounce or pound – however you use it), supplier batch/lot numbers, your assigned batch number if you have one, where it is stored, how it was inspected, etc. You could file them by date, by supplier and/or by type of ingredient.

For each batch of product you make, have a separate sheet with the recipe and procedures printed out and ready (I call mine a Batch Record sheet).  Assign a batch number to each batch (I use the date with a letter for each batch of the day – 20110601-A, 20110601-B, etc). As you make the product check off or fill in all the blanks for how much was used, who measured it (double check!), the batch/lot number of the ingredient (which will tie back to the ingredients/supplies documentation binder), what was done at each stage of the process.  Be sure to include any adjustments you had to make during the production process, if any.

If you have been keeping the cost of the ingredients accurately calculated, you will be able to calculate the exact cost of the batch, based on the actual ingredients you used in it.

When completed, test (either actual test or by inspection) and make a note of the results.  Take a small sample of the product from the batch, put that batch number on it, and store it safely (see #5 Production, and #6 Laboratory Controls in Part 2).

When you label the product, put the batch number the label for the product.  If you print your own labels, this is easy.  If you have labels already printed, make a space in the design so you can hand-write or print the batch number on each label before it is applied to the product.  Also attach a copy of the label to the Batch Record sheet.

Note that the Batch Number is not required on the label according to the labeling regulations, but it is considered to be part of Good Manufacturing Practices to have it on the label.  That way if any batch goes bad, you will know exactly which products were in that batch and can handle it more easily.

Finally, make a note of what was done with the product.  Was it for one customer?  Prepared to keep in stock to fill orders?  Whatever it was, write it down on the Batch Record sheet.

Keep the Batch Record sheets in a binder, in date order (or, if you prefer, keep sections for each type of product and keep the Batch Record sheets in date order by type of product).

Much of the information needed for both ingredients and on the Batch Record sheets can be kept in a computer file using MS Word or Excel, a text file or a specialized program.  You can also scan the paper documents (Batch Records with the production data handwritten, labels, MSDS and technical specs for ingredients and invoices) and keep them electronically.  BE SURE TO KEEP BACKUPS.  Having an offsite backup is good as well – just in case.

However, even if you have everything electronically, you should still have a paper record which can be easily referred to and contains the original data.

Bottom line, keep a record of everything – from beginning (receipt of ingredients) to end (final disposition of the product).

For the rest of the series, see:

• GMP Part 1, which covers Building and Facilities, Equipment and Personnel.
• GMP Part 2, which covers Raw Materials, Production and Laboratory Controls.