Posted by Rick Soltero
The FDA inspections of dietary supplement manufacturers have resulted in 1 in 4 producers getting a
Warning Letter that could shut down their business. We have analyzed the inspection notices from these
manufacturers and wrote this series of articles in the hope that we can give you some ideas for
improving your own state of compliance. These ideas are grounded in the GMP for Dietary Supplements Final Rule.
One of the most common failures cited by FDA inspectors in Warning Letters is lack of adequate
documentation. As an example, a dietary supplement manufacturer in Ohio was issued a warning letter that described
in detail how they failed to make and keep written procedures for specifications, Quality Control
operations, Master Manufacturing Records, returned goods and equipment.
The FDA wanted to see written documentation that specifications were set and testing was completed
before using a component or ingredient in manufacturing. They expected documentation to show quality
control personnel performed the review and disposition of products at the time of performance. They
also wanted to see written master manufacturing records (MMR) for each unique formulation of dietary
supplements. When the firm first promised to provide written procedures and then failed to produce
them, the FDA issued their warning that failure to provide adequate documentation may result in
seizures and injunctions.
Why good documentation is important
There are many GMP requirements for making and distributing good quality dietary supplement products.
It would be hard to stay in compliance if there were no written procedures that describe how to assure
that each of the requirements are met. The production and quality staff can be easily trained and can
stay in compliance if there are written procedures for them to read when they first start the job and
that they can refer back to when they need a refresher.
Without written procedures, the staff may not remember the correct way to do things or they may do the
steps differently over time. Written procedures enforce uniformity and quality which is what consumers
deserve and the FDA expects.
What Can You Do to Improve?
Our first rule of GMP compliance is “Document what you do, and do what you document.” The FDA guidance
document on GMP
for Dietary Supplements has very thorough instructions on what is required for compliance. You can
interpret their guidance and write up your own processes for how you will do each of the major
functions of GMP manufacturing. Once you have the documented your processes as Standard Operating
Procedures, just follow them each time.
FDA hot buttons: All of the FDA’s requirements are listed in their GMP regulations, however there
are some issues that are more commonly cited. You can avoid these citations if you:
- Establish written procedures for manufacturing operations
- Make and keep records of the written procedures for cleaning the physical plant and
- Make sure quality control personnel approve or reject all processes, written procedures,
controls, tests and examinations, and deviations
- Have a control process for the issuing and using the product labels.
- Set up procedures for sampling and provide a cross-reference to procedures for tests or
- Document corrective action plans for use when a specification is not met.
- Demonstrate that quality control personnel reviewed the results of tests or examination
of any in-processing or finished product at the time of performance
- Keep written records as required for one year past the shelf life date, if the
shelf-life dating is used, or two years beyond the date of distribution of the last batch of the
dietary supplements associated with the records
To make it easy for you to get into or to stay in compliance, InstantGMP Consulting Services can provide a complete set of manufacturing Standard
Operating Procedures (SOPs) and Policies for GMP manufacturing. You can choose
individual SOPs to supplement what you already have or you can use the entire set as a foundation for
a complete quality system.