Industry standards and certifications hold companies to a high standard and help consumers have confidence in the products they purchase. In the world of dietary supplements, a GMP certified facility can demonstrate its dedication to creating quality products under the best conditions.
Below, we’ll define GMP certification, explain how it benefits manufacturers and consumers, and outline the importance of verifiable standards in the industry.
What Does It Mean to Be GMP-Certified?
GMP stands for Good Manufacturing Practice. A GMP certified manufacturer adheres to a system of standards originally established by the US FDA, designed to ensure the consistent manufacturing of quality products under safe conditions. The certification is granted after thorough audits of a facility’s processes, conditions, documentation, and quality control measures.
GMP certification covers everything from raw materials to equipment, staff training, and facility hygiene.
Why Is it Important to Be GMP-Certified?
GMP certification is essential when searching for the right manufacturing facility to source and manufacture your line of supplements. A certified facility affirms that products are held to high quality standards and manufactured in clean, controlled environments. Required procedures must be followed, from sourcing and handling safe ingredients to auditing and reporting on outcomes.
At the end of the day, GMP certification removes a long list of uncertainties about a facility’s operations and business practices, ensuring that what you put on the shelf lives up to your standards and prioritizes consumer health and safety.
Benefits to Manufacturers
A GMP-certified supplements manufacturer demonstrates its commitment to quality and safety to potential customers. This is invaluable for building trust with clients and extends to retailers who can attest to consumers that the highest-quality ingredients are handled under standardized facility conditions.
GMP certification helps manufacturers be better prepared for regulatory inspections and reduces the frequency and costs associated with audits.
Risks Involved with Manufacturers that Aren’t GMP-Certified
Non-GMP-certified facilities lack the oversight to confirm ingredients are sourced, handled, and produced to a standard of compliance. This can lead to multiple adverse outcomes:
- Product contamination
- Fees or other penalties for violating compliance standards
- Difficulty competing for clients
- Product recalls
- Forced factory shutdowns
- Lack of access to markets that require certification
How Does GMP Certification Affect Product Safety and Quality?
GMP certification guidelines require stringent controls regarding foreign materials, microbes, and chemicals. These guidelines also offer standards for consistent manufacturing processes to ensure safety and prevent contamination.
This standardization of practices includes controlling temperature and humidity conditions and setting standards for cleanrooms and waste disposal.
The combination of quality control and standards at each stage of production, comprehensive documentation and recordkeeping for product traceability, and the required adherence to regulatory standards, audits, and inspections ensures safe products of the highest quality are manufactured at GMP-certified facilities.
What Standards and Practices Must a Manufacturer Meet to be GMP-Certified?
GMP certification includes the following stringent standards and practices:
- Implementing a vigorous quality management system (QMS)
- Maintaining sanitation and hygiene standards
- Establishing and following a standard for raw material controls
- Standardizing manufacturing processes
- Utilizing a comprehensive employee training process
- Maintaining proper documentation
- Testing products at multiple production stages
- Correcting non-conformities and implementing preventative measures
- Participating in audits and inspections
- Managing supplier quality control
How Does the Certification Process Work, and Who Grants GMP Certification?
GMP certification is granted by accredited third-party organizations and regulatory bodies. Certifying organizations include:
- The National Sanitation Foundation International (NSF)
- The Natural Products Association/Underwriters Laboratories (NPA/UL)r dietary supplements
- The US Food and Drug Administration (FDA)
According to the NSF, certification involves the following steps:
- Application submission
- Proposal and agreement
- Pre-audit planning
- On-site audit
- Audit report
- Corrective actions
- Certification decision
- Ongoing compliance
This GMP certification process helps manufacturers meet requirements for regulators and retailers while establishing trust throughout the entire supply chain.
How Does GMP Certification Impact the Pricing of Manufacturing Services?
GMP certification can lead to higher costs due to auditing fees, upholding quality control, and other related investments. These costs are minimal compared to the competitive market benefits of being certified, and often manufacturers offset expenses with reduced prices for long-term clients and for bulk orders.
Are There International Differences in GMP Standards?
There are numerous independent GMP standards, as many third-party organizations regulate them. Some variations in standards stem from not all countries agreeing on what constitutes a supplement, which impacts the degree of testing and approval phases of development.
However, international agreements for recognizing these standards do exist; they keep general GMP standards consistent from one country to the next, so the focus remains on helping facilities uphold those standards.
Independent third-party organizations like the National Sanitation Foundation (NSF) whose GMP certification process and accompanying services are internationally recognized allow manufacturers like Soft Gel to adhere to an international standard. The NSF is an internationally recognized, independent organization that sets GMP standards and provides testing, auditing, and certification services.
The European Medicines Agency (EMA) collaborates with organizations from multiple countries to align standards, regulations, and shared inspections. This includes collaboration between the EMA and FDA, based on their mutual recognition agreement (MRA), which aligns EU, US, and UK practices.
About Soft Gel: Your GMP-Certified Manufacturing Partner
Soft Gel proudly holds third-party GMP certifications through NPA/UL and NSF. This includes NSF’s GMP for Sport. We are Halal-certified and are an approved Health Canada foreign manufacturer. As your supplement manufacturing partner, we ensure:
- Strict quality control
- Regulatory compliance
- Consistent processes
- Use of quality ingredients
- Safest production conditions
Learn about our portfolio of branded and patented soft gelatin capsules or get in touch with us to discuss how we can custom-make supplements exclusively for you.
Frequently Asked Questions
How often are GMP-certified facilities inspected or audited?
Supplement manufacturers typically undergo audits 1–2 times per year. This may include unannounced inspections, post-certification follow-up audits, and surveillance audits. More follow-ups may occur if compliance or corrective measures are involved.
What does GMP certification entail for a manufacturer?
GMP certification involves implementing robust quality management, maintaining facilities and equipment, training employees, rigorous product testing, keeping detailed records, and ongoing third-party audits.
What are the benefits of working with a GMP-certified manufacturer?
Working with a GMP-certified manufacturer ensures that the operators and facility have been inspected and audited to verify that they meet quality and safety standards. This gives you confidence that you are selling products that are well-sourced and produced under high-standard conditions.
How does GMP certification impact the product development process?
GMP certification impacts production at every stage. It involves quality controls for sourced ingredients and suppliers, the structured manufacturing environment, rigorous testing, reporting, and auditing. Manufacturers are required to follow regulatory guidelines for compliance, practice proper employee training, and uphold effective risk management in identifying and mitigating risks to quality or safety.
When searching for the right supplement manufacturer, verify whether they:
- Are FDA registered
- Can produce a recent FDA inspection rating and acceptance letter
- Are GMP-certified
How can I verify a manufacturer’s GMP certification?
There are multiple ways to verify whether a manufacturer is GMP certified, but the easiest way is to go to NSF’s website and search for the manufacturer in their certification database.
