Supplement quality control from white label and private label manufacturers is critical for retailers looking to offer safe and effective supplements for their customers. From the raw materials sourced to final product testing, every stage of the manufacturing process impacts the quality of the final product.
Below, we will examine how supplement quality is determined, what certification processes exist to ensure a high standard in production, and how Soft Gel Technologies exceeds industry expectations to offer the highest quality supplements.
How to Evaluate the Quality of a Supplement
Unbiased supplement quality controls involve more than just the ingredients sourced; they also largely center around the manufacturing facilities and their processes.
Verifying the quality of a supplement is just as much about establishing that a manufacturer’s processes, equipment, and operating conditions all meet or exceed regulatory standards. The whole picture of supplement quality control includes:
- Raw material testing: Manufacturers must rigorously test raw materials to verify that they are pure, not blended with added ingredients, and have the correct strength and concentration of active compounds.
- Manufacturing process controls: Facilities and equipment must be clean, prevent cross-contamination, follow defined processes, and conduct tests at multiple production stages to verify ingredient mixes, temperatures, and other conditions.
- Finished product testing: The finished product is tested for its potency and purity to verify the accuracy of dosage and shelf life and to ensure that the supplement is free of harmful bacteria or mold.
What Role Does Third-Party Testing Play in Evaluating Product Safety?
Supplement manufacturers can make claims, but third-party agencies provide independent verification or quality standards at multiple stages of production to validate whether reality matches manufacturer claims.
How Does Soft Gel Technologies Display Transparency In Its Processes?
Soft Gel is dedicated to maintaining the highest quality standards and undergoing certification and related audits to demonstrate its dedication to excellence. This includes:
- Quality assurance of raw materials, in-process quality checks, and final product testing
- Solvent-free, US-based manufacturing practices
- An open approach to product development, including ingredient safety, efficacy, and clinical studies
- Dedication to environmental responsibility, with lean manufacturing energy use, power consumption, and related practices
- An emphasis on open communication with customers regarding the manufacturing process
- Providing full documentation and recordkeeping to third-party auditors
- Following certification processes that ensure industry standards
What Is NSF Certification for Supplements?
The National Sanitation Foundation (NSF), now called NSF International, is an independent organization that provides certification for dietary supplements.
NSF certification involves a comprehensive process to ensure product quality and safety, which includes:
- Verifying the product contains what is listed on its label
- Assessing the product formulation
- Testing for undeclared ingredients or contaminants
- Ongoing monitoring with annual audits
NSF certification provides an added level of quality assurance for consumers to help them make informed decisions based on supplement quality and safety. NSF certification includes regulations defined by current Good Manufacturing Practices (cGMPs).
What Is cGMP?
Current Good Manufacturing Practices are regulations enforced by the FDA, which include dietary supplements. These regulations provide guidelines for designing, monitoring, and controlling manufacturing processes and facilities, including quality management, standards for raw materials, procedures, testing, equipment, and personnel.
Why Is It Important to Be cGMP-Certified?
GMP certification affirms a high standard for the manufacturing of products in a clean, controlled environment. For manufacturers, it is an opportunity to build trust within the industry and with retail customers.
Certifications communicate quality and transparency regarding a manufacturer’s:
- Quality management system (QMS)
- Sanitation and hygiene
- Raw material controls
- Manufacturing process
- Employee training
- Maintaining proper documentation
- Testing products at multiple stages of production
- Preventative and corrective measures
- Participation in audits and inspections
The FDA originally established Current Good Manufacturing Practice standards to oversee consistent manufacturing of quality products under safe conditions, and cGMP certification is granted via third-party organizations and regulatory bodies, including:
- The National Sanitation Foundation International (NSF)
- The Natural Products Association/Underwriters Laboratories (NPA/UL) partnership on dietary supplements
- The US Food and Drug Administration (FDA)
The NSF developed the NSF/ANSI 455-2 standard for dietary supplement cGMP certification. This incorporates the FDA’s 21 CFR Part 111 regulation, industry best practices, and retailer quality requirements; cGMP certification requires audits of a facility’s processes, conditions, documentation, and quality control measures, including:
- Raw materials
- Staff training
- Facility hygiene
Soft Gel holds third-party certifications through NPA/UL and NSF, including NSF’s GMP for Sport. You can view our NSF certification on the NSF website.
These internationally recognized, third-party GMP inspections and certifications help assure our customers that the products we manufacture meet the standards they demand for purity, potency, and quality.
The ISA certifies us as Halal; Health Canada approves us as a foreign manufacturer.
What Are the Challenges for Non-GMP Certified Manufacturers?
For manufacturers that are not GMP certified, clients have to worry about potentially contaminated supplies or substandard quality. Manufacturers could face penalties for violating regulations, which in turn makes it very difficult for them to compete with higher-quality facilities.
Quality Control Steps in Soft Gel Manufacturing
Regulations generally treat the quality standard as an examination before, during, and after production, ensuring quality products enter production, compliant manufacturing conditions are maintained, and the end result matches the claims made about the product. This is sufficient but doesn’t guarantee excellence.
How Does Soft Gel Maintain Consistency and Safety?
Soft Gel is a cGMP-certified manufacturer, using recognized third-party audits that ensure compliance with:
- Facility maintenance
- Hygiene standards
- Handling raw materials
- Other raw material controls
- Testing at key production stages
- Participation in audits
- Precision of equipment
Beyond compliance, Soft Gel takes an additional sequence of steps, starting with the initial receipt of materials, in-process checks, and final product analysis. Soft Gel employs advanced analytical methods and state-of-the-art equipment, including high-performance liquid chromatography (HPLC), mass spectrometry, and other advanced testing methods used to verify product composition and purity with every batch of ingredients.
Add to this multiple redundant quality checkpoints to address any quality or purity variance before the final stages of production. Soft Gel maintains documentation at every step of production for full traceability of materials, conditions, and processes.
Ensuring the Purity and Potency of Ingredients
Soft Gel’s quality control of supplements involves carefully sourcing high-quality ingredients from an extensive network of trusted suppliers and testing them for quality, safety, purity, and potency. We have a strict supplier qualification program with detailed assessments and rigorous standards.
We test raw materials for contaminants like heavy metals, pesticides, and microbiological agents to hold the highest standard of premium ingredients.
We have invested millions of dollars in state-of-the-art blending and encapsulation equipment. Inspection of this process is temperature-controlled using precision equipment designed to meet the requirements of Title 21 of the FDA Code of Federal Regulations (CFR) Part 111.
Why Partner with Soft Gel?
Soft Gel Technologies displays our commitment to quality and safety in soft gel capsule supplement manufacturing through a rigorous process, comprehensive testing, and stringent quality control measures. We do this to ensure absolute consistency in batch-to-batch quality and efficacy.
Our investment in state-of-the-art equipment and real-time monitoring allows us to maintain precise control over our product’s size, shape, weight, and seal integrity, which helps us optimize the product presentation and bioavailability of active ingredients.
Our certifications and compliance speak to our excellence and transparency to build your trust and exceed your expectations.
Soft Gel aims higher than compliance expectations regarding details like monitoring the gelatin temperature, seam width, the quality of our drying process, and the ribbon thickness of our supplements. Add to this our precise formulations, skilled staff, and sustainable practices, which make Soft Gel a leader in reliable bulk production.
Get in touch with our experts to discuss partnering with us today.
