A Brief Guide to Federal GMPs for Dietary Supplements

Ensuring quality, safety, and integrity of the dietary supplements require nutraceutical companies to build a culture of quality and meet compliance with Federal GMPs. Thankfully, the development of advanced technologies has made quality management for nutraceuticals more straightforward than ever.

With the increasing popularity of dietary supplements, the concern for quality and safety is also on the rise. Nutraceuticals companies need a next-generation approach to manage quality and ensuring product integrity. It will help them restore customer confidence and ensure good health for everyone.

Nutraceutical’s quality management has also gained regulatory interest and compliance enforcement. Due to active ingredients in the supplements, an overdose may pose health risks and can even cause adverse events.

All the conversation around the safety and quality of dietary supplements implies the need for more regulated management of dietary supplements and their ingredients. But a thorough approach requires nutraceutical companies to keep everything documented, including:

1. Amount of Active Ingredients to be used in a supplement, 
2. Extraneous materials used in the supplement,
3. Safer substitutes of the synthetic substance,
4. Inspection of the materials that are claimed naturally derived,
5. Products adulteration details (if done with drugs or their analogs), and more.

In addition to documentation, standardizing the processes as per industry best practices can help nutraceutical organizations gain a strategic advantage.

In this post, we will look at all the best practices and regulatory guidelines defined under Federal GMPs for Dietary Supplements. The guidelines include:

• Stringent requirements for manufacturing, packaging, labeling, and holding dietary supplements.
• Evaluating identity, quality, purity, strength, and composition of the dietary supplements and their dietary ingredients.

If you want to meet the requirements of the DS CGMP rule, you must perform the following activities:

• Approving or rejecting any deviations from or modifications to controls, procedures, tests, and examinations that could possibly affect dietary supplement identity, purity, strength, or composition.
• Any supplier’s qualification documentation shall be reviewed and approved.
• Examining and approving supplemental information explaining why meeting in-process specifications, combined with component specifications, is intended to improve dietary supplements’ integrity and composition.
• Reviewing and approving the documentation set out reasons why the dietary supplement’s finished batch will meet the product specifications.
• Examining and approving the documentation for any exempted product specifications that are mandatory, as well as any in-process documents or other tests that are necessary for ensuring compliance with such requirements.
• Providing all representative samples.
• Collecting and storing all reserve samples.
• Verifying whether all specifications of 21 CFR 111.70(a) are met.
• Detailed procedures for a laboratory (21 CFR 111.110);
• Material review and disposition decisions (21 CFR 111.113);
• Equipment, instruments, and controls requiring maintenance and repair (21 CFR 111.117);
• Before producing dietary supplements, appropriate actions must be taken regarding the components, packaging, and labels.
• Manufacturing operations need to be entered into the master manufacturing record, batch production record, and manufacturing records (21 CFR 111.123);
• Packaging and labeling operations (21 CFR 111.127);
• Management of returned dietary supplements (21 CFR 111.130); 
• Product complaint procedures as defined under (21 CFR 111.135).

Supplement manufacturers must follow the above-mentioned good manufacturing practices to deliver safe and accurately labeled products to consumers and achieve public health benefits.

Here’s the detailed version of Federal CGMP for Dietary Supplements.

But Are GMPs Making Any Difference to Quality of Dietary Supplements?

Certainly!

Building processes as per GMPs best practices can drive multiple benefits for the nutraceutical companies since it helps them to

• Ensure that product is free of contamination or adulteration.
• Take steps to avoid mix-ups and errors.
• Spread awareness about what needs to be done and how it needs to be done.
• Control the manufacturing process and ensure consistent results.
• Ensure quality product and process design goes into manufacturing.
• Keep track of what happened throughout the entire production cycle.
• Have an experienced team for reviewing and deciding to release or reject the project.
• Standardize processes to resolve quality issues, learn from mistakes, monitor operations, and continually improve.
• Deliver products that meet their stringent quality standards.

Traditional v/s Next-Generation Approach: What’s Better?

The traditional approach to quality management may get ineffective and inefficient with the constantly growing challenges. The compliance requirements are also getting stringent every day. Therefore, nutraceutical companies require robust and scalable quality management software that can grow with their business needs.

We all understand and agree with the fact that “Change is the only constant.” Upgrading to EQMS software is the change that nutraceutical companies need. An effective quality management software helps streamline quality processes while mitigating operational and compliance risks. It also provides more control and insights into quality data for better decision-making. Most importantly, it helps build a closed-loop quality system to foster a continuous improvement culture without any extraneous efforts.

Therefore, for the nutraceutical industry to evolve, the companies must be comfortable with the change that the next-generation approach will bring. It will enable them to manage risks more effectively and efficiently than before. Most importantly, there will be lesser wastage, materials rejection, and rework.

Which EQMS Software to Choose?

Considering the need for flexibility, scalability, and reliability, it would be best to invest in a cloud-based EQMS software like Qualityze EQMS Suite.

With Qualityze Enterprise Quality Management Software, nutraceutical companies can:

• Establish best practices workflows to streamline and standardize quality processes.
• Perform timely inspection of chemicals, active ingredients, adulteration materials, substitute substances, and much more.
• Optimize supplier quality using a pre-defined supplier questionnaire and avoid supplier risks.
• Manage and maintain quality documentation.
• Perform timely review of quality and compliance requirements to ensure SOPs are up to date.
• Track adverse events, inconsistencies, and change conditions through the system.
• Keep a check on the quality, safety, and purity of the dietary supplements before delivering them to the customers.
• Improve employee competency by keeping them trained on best practices and compliance requirements for packaging, labeling, and handling dietary supplements.
• Manage equipment calibration and maintenance schedules to ensure consistent quality outputs.
• Assess and eliminate the quality risks and their root cause(s).
• Manage and resolve customer complaints while keeping every record.
• Keep track of activities performed through audit trails.

These are just a few to mention. You can control and manage every process that contributes to product quality. It comes with KPI Dashboards, Reporting Tools, E-Signature, Centralized Database, Intuitive Platform, and much more to simplify nutraceutical quality management while meeting compliance with applicable regulatory standards.

Don’t you think it is time to upgrade to quality management software?

If yes, please get in touch with our customer success team at info@qualityze.com or call us on 1-877-207-8616. We will configure the quality management software to meet your business-specific needs.