[Case Study] Quality Assurance: Supplements & Products On Fullscript


In this article, you will find:


As a practitioner, quality is the most important factor to consider when looking for a trusted source to provide health products for patient wellness. An abundance of policies and processes can make it difficult to find exactly what you’re looking for and may defer time away from patient care in order to understand quality assurance. You may also be faced with multiple solutions and may not know which to choose.

At Fullscript we make it easy to access the information you need about the quality of our products by maintaining transparency with our users and by following national & international regulations and policies.

man looking at inventory in warehouse

Maintaining high standards in warehouses, where supplements are stored before being delivered to patients, is important for all Fullscript facilities.

The importance of quality is equally relevant all the way from the product’s production to consumption. Throughout the lifecycle of a supplement, care and quality assurance is necessary to ensure that the end consumer – your patient – is getting what they need to optimize their health.

Our quality assurance team knows what to look for when taking care of more than 15,000 products, partnering with over 300 suppliers, and keeping products at their individual standards in our warehouses.

Why is quality important for supplements?

Quality control for supplements is crucial as they help keep people healthy! If supplements are not manufactured and resold under quality supervision, they can end up with expired ingredients, cross-contamination, improper labels, and other severe issues that can risk consumers’ health.

Dietary supplements and wellness products are approached differently than pharmaceuticals. In the United States, the Food and Drug Administration (FDA) oversees the regulations and practices for supplements and natural wellness products. The importance of assessing products helps establish Good Manufacturing Practices (GMPs). The standards look at the identity, purity, strength, and composition of each product that is manufactured. (1) In Canada, Natural Health Products (NHPs) are regulated by Health Canada under the Natural and Non-prescription Health Products Directorate (NNHPD). (2)

Good Manufacturing Practices (GMPs)

These standards are meant to allow all manufacturers and resellers of supplements to avoid unsafe and incorrect ingredients in products. The GMP standards also ensure that the possibility of contamination and the improper packaging and labeling of a product is avoided. (1)

The standard allows resellers, like Fullscript, to stay accountable for overall health and safety.

Current Good Manufacturing Practice (cGMP)

Good Manufacturing Practice (GMP) is also sometimes referred to as cGMP, where the ‘c’ stands for ‘current’. (3) The Current Good Manufacturing Practice (cGMP) reminds supplement manufacturers and resellers to stay up to date with their processes, equipment, technologies, and policies in manufacturing and reselling supplements. (3) The FDA developed cGMPs to ensure supplements are produced in a consistent manner and meet quality and safety standards. (4)

How does Fullscript ensure quality?

To ensure our catalog provides the best quality options to practitioners, we’ve partnered with the best professional-grade supplement brands who follow cGMP standards. You can know that everything you search for on Fullscript is manufactured to improve patient care, taking the worry off of you, and saving you time in deciding what to recommend.

Trust in knowing the products you recommend to your patients are from vetted manufacturers, have been stored in compliant warehouses, and will be delivered with the utmost care.

close up of two hands pointing pens at a notebook

To become a partner and supplier on Fullscript, all vendors must go through an in-depth questionnaire and provide quality information.

I always receive the best service from Fullscript. It is easy to connect to the platform, purchase and receive products. I am very comfortable knowing that the products I recommend are top of the line. -Doreen T., RN

Onboarding of brands

Maintaining the largest catalog in the industry takes an entire internal team to ensure processes and policies are followed so brands can join our catalog. The Fullscript onboarding process for brands is in-depth and consists of a quality control questionnaire. This document qualifies information about Brands on the following points:

  • Quality assurance policies and processes
  • Internal training programs on quality maintenance
  • Description of internal quality teams
  • cGMP auditing & certifications
  • Manufacturing personal information (both internal and external)
  • FDA inspections
  • Label, and facility testing
  • Finished goods quality testing practices
  • Raw ingredient information
  • Compliance reporting
  • Recall procedures

These questions help us identify the quality of the ingredients in the final product that the manufacturer produces and sells to us. Without the process, we would not be able to asses the brands that we carry and provide to practitioners, like you.

Did you know?
On average Fullscript onboards 5 new brands to the catalog on a monthly basis. With quality processes, the brands being added to the catalog are the best for patient care.

The more we know about brands and products, the better service we can offer to practitioners. With information, we’re able to improve features like advanced search so you can find products based on allergens, formulations, ingredients, and more! Our quality assurance also allows us to pass along information such as therapeutic value.

Fullscript encourages brands to undergo 3rd party certification programs, to ensure and further validate product quality. Amongst others, certifications include:

  • cGMP
  • ISO 9001 (5)
  • non-GMO (6)
  • USDA Organic (7)
  • NSF Gluten Free (8)
  • TGA (9)

If a supplement manufacturer meets GMP standards, they will have the cGMP designation. You can be confident that the products we carry are authentic, have been monitored to guarantee no contamination, and have been manufactured consistently and safely.

Storage of supplements

At Fullscript, we operate by cGMP standards, including our distribution centers’ policies and processes. As a company, we’re compliant to the National Sanitation Foundation (NSF) guidelines. (10) Everything from the storage of supplements, to transport and delivery, is all carefully monitored and controlled.

To be labeled cGMP certified, we also follow the 4 categories of good manufacturing practices:

  1. Places – ensures that the location where products are stored is clean
  2. People – ensures that employees are trained on proper cleanliness and safety processes
  3. Processes – ensures that there are consistent operations to provide authenticity and safety
  4. Products – ensures that products are checked throughout manufacturing, storage, and delivery for authenticity, safety, and accuracy

Places

Our facilities follow safety codes and are up to manufacturer standards. Products are stored in 68-77 degrees Fahrenheit and 36-46 cold storage, with humidity at no more than 60 percent. These measures ensure heat sensitive products are separate from those that do not require temperature attentiveness. Within our facilities, temperatures are monitored and logged 24/7, 365 days a year. Our facilities are totally secure and visitors are logged for safety purposes.

Preventative maintenance and calibrations for critical storage components include:

  • HVAC
  • Cold storage
  • Weight and measures equipment

Our facilities are also constantly tested for pest control, sanitation standards, personal hygiene, document control, preventative maintenance, and more!

People

When storing supplements in our warehouses, we ensure our employees go through a training program to successfully handle all products, including temperature-sensitive products such as probiotics. Fullscript employees learn about supplementation, ingredients, and have the confidence to identify and handle different ingredients.

woman with reading glasses looking at her laptop

Our quality processes are followed by team members inside and outside of our distribution facilities.

Processes

Our processes for storing products are followed by every team member at Fullscript, both inside and outside our facilities.

Product recall process

In rare circumstances, product recalls may occur. We make sure to assist in the recall process by alerting our practitioners in these cases and can provide guidance in dealing with product returns or disposal. The obligation is on us, and we have a rigorous recall process, including a dedicated team that oversees recalls that affect the catalog and monitors the process from manufacturer to the end user.

Whether the recall is voluntarily initiated by the brand or is mandated by the FDA, we have three touch points, with both the healthcare practitioner and patients, via email and regular mail to ensure that procedures are in place to assist in the recall process. Unfortunately, many supplement resellers do not establish recall procedures which may expose you and your patients to health and safety risks. Our strict policies and processes for product recalls can give you confidence that your patients’ health and safety is at the center of our attention.

Product complaint process

You can also rest assured that we have a quality consumer complaint procedure. We record everything the compliant entails and make a point to report it internally as well as to the brand in question. Complaints help us forecast possible voluntary recalls and they also help us constantly evaluate the quality of the brands we work with. Our customers are always heard.

Products

Products that are stored in our facilities are cared for from the moment they get to the warehouse to the moment they get to a patient’s home. We keep a log of all products through lot tracking. We can be confident in having an overview of all products in the warehouse at any time. This is important for instances where recalls happen. Focusing on temperature standards also allows us to make sure heat-sensitive products are cared for appropriately and maintain their potency.

Wonderful products, prompt service and delivery. My Physician recommended that I purchase my supplements from Fullscript because of the purity of their products. -Frankie J., Patient

Direct shipments to patients

Once supplements are recommended and ready to be shipped to patients, we package them with care and make sure they are stored properly. Heat sensitive products are shipped with a cold pack to keep them cool. Although short-term heat exposure may not affect the potency of heat-sensitive products, we follow standards to control and monitor the temperature of the product even after it has left the warehouse.

Each product is packaged and tracked with care. We deliver quality supplements to the patient.

The bottom line

When it comes to quality, there are no shortcuts. At Fullscript, we understand that the focus on quality starts from selecting the right brands to include in our catalog, and does not end until the recommended product has been delivered to the patient.

Supplement resellers who do not specialize in supplements may not establish quality control assurances. They may not have processes in place for recalls and complaints, and they may not utilize warehouse optimization strategies and training programs for staff.

Potential new brands are always reviewed by our team to ensure quality. The Fullscript Quality Assurance Team reviews all products, including their standards, certifications, any associated complaints, unsubstantiated claims, compliance with FDA guidelines, and more.

Tips for practitioners: always look for certifications – if Current Good Manufacturing Practices are not met, the quality of products may be in question. Choose the right resellers to partner with so that you can optimize patient care.

If you are a practitioner, consider signing up to Fullscript. If you are a patient, talk to your healthcare practitioner about Fullscript!

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