27.06.2024

Supplement Manufacturing Accreditations Explained

As a company seeking to manufacture and sell supplements, you have undoubtedly encountered a multitude of colourful accreditation logos on various products. These logos are designed to convey trust and credibility, but understanding their true meaning, usefulness, and relevance can be daunting. Are they genuinely beneficial for your business? Do they align with your specific needs?

In this blog, we will demystify these accreditations, equipping you with the knowledge to identify which certifications are valuable and which ones you should be cautious of. You will be well-informed about the standards required to ensure your products meet industry expectations and cater effectively to your target market. 

What are Supplement Manufacturing Accreditations?

Supplement accreditations are independent audits of a manufacturer’s quality management systems, conducted by recognised third-party bodies. These audits are performed to an agreed standard, ensuring that the manufacturing processes meet specific criteria for quality and safety.

During an accreditation audit, the quality processes of a manufacturer are meticulously compared against the established standard. This involves a thorough examination of various aspects of production, from raw material sourcing to final product testing and packaging. The goal is to ensure that every step in the manufacturing process adheres to the highest quality benchmarks.

Standards for supplement manufacturing are regularly updated to incorporate the latest industry advancements and regulatory requirements. Manufacturers are expected to consistently follow the latest standards, ensuring their products remain compliant with current best practices. Adhering to these standards not only helps in maintaining product quality but also in building trust with consumers and business partners alike.

 

  • Definition: Independent audits of a manufacturer’s quality management systems.
  • Conducted By: Recognised third-party bodies.
  • Purpose: Ensure manufacturing processes meet agreed quality and safety standards.
  • Audit Process:
    • Compares quality processes against the established standard.
    • Examines raw material sourcing, production, testing, and packaging.
  • Standards:
    • Regularly updated to reflect industry advancements and regulatory changes.
    • Manufacturers must follow the latest standards.
  • Benefits:
    • Maintains product quality.
    • Builds trust with consumers and business partners.

 

Understanding the Grading System Used by Accrediting Bodies

Accrediting bodies employ different grading systems to evaluate the quality management systems of supplement manufacturers. These systems help determine the level of compliance with established standards.

  • Pharmaceutical Level and Medical Devices:

    • Grading System: Pass/Fail
    • Nature: These standards do not use a grading scale. Manufacturers either meet the stringent criteria or they do not.
    • Difficulty: Due to the lack of gradation, passing these audits is particularly challenging, reflecting the high standards required in these sectors.
  • Food and Dietary Supplements:

    • Grading System: Letter Grades
    • Evaluation: The number and severity of non-conformities identified during the audit determine the grade awarded.
    • Ease of Passing: While obtaining a passing grade is relatively straightforward, achieving an ‘A’ grade necessitates a near-perfect operation with minimal non-conformities. Grades start at a D grade and work their way up.

This grading system allows for a nuanced assessment of a manufacturer’s adherence to quality standards, with higher grades indicating a stronger compliance and more robust quality management system.

What are the best supplement accreditations

In this section, we will explore the top supplement accreditations that signify excellence in quality and safety. Each accreditation will be discussed individually, providing insights into its significance and the standards it upholds.

GFSI (Global Food Safety Initiative)

 

The Global Food Safety Initiative (GFSI) sets the highest standard for supplement accreditations. Rather than conducting audits themselves, GFSI recognises a number of certification programme owners who are authorised to carry out these assessments. 

This accreditation is considered the pinnacle of quality and safety standards in the supplement industry.

GFSI Recognised Bodies

The following are GFSI recognised bodies. Holding certifications from these organisations indicates that a manufacturer adheres to the highest quality processes available.

As these bodies all follow the same GFSI guidelines, as such there is very little difference between them. As long as a manufacturer has a GFSI recognised accreditation, you can be sure they will be following the highest safety standards.

IFS

 

 

SQF

 

 

BRCGS

 

 

FSSC 22000

 

NSF GMP (Good Manufacturing Practices)

NSF

In the United States, they do not deem supplements as food. They categorise them under dietary supplements and as a result, GFSI regulations are not relevant for them as GFSI is specifically for food.

The NSF-GMP standard is created specifically for dietary supplements and only relevant for the United States. It is a certification program that is based on guiding principles set forth in the FDA 21 CFR 111 regulations.

What are the food supplement standards across different global regions?

Each region recognises different quality standards, so it’s crucial to understand which accreditations are necessary for selling your product in those areas.

If your product is manufactured in a facility whose accreditations are not recognised in your chosen location, you will need to remanufacture your product in a facility with the appropriate accreditation.

The following are the highest accreditations required in each region. These certifications are essential if you want to sell in retail stores and register your product in these areas.

South America – NSF-GMP

GCC – NSF-GMP

Asia – Majority NSF-GMP but some will take GSFI

Europe – GFSI

Australia – Pharmacy grade (MHRA or equivalent)

accreditation map

What accreditations should you be wary of?

While many accreditations signify high standards of quality and safety, some may not meet the stringent requirements necessary for certain markets or consumer expectations. It is crucial to understand the limitations of these accreditations and assess their suitability for your business needs.

SALSA (Safe and Local Supplier Approval)

Salsa

SALSA is an accreditation designed for smaller food manufacturers who may not be ready for the full BRCGS audit. While it provides a standard for food safety and quality, it is often aimed at businesses that are too small or have limited resources to achieve higher-level certifications like BRCGS. 

  • Intended For: Smaller companies not prepared for a full BRCGS audit.
  • Standard Level: Lower than BRCGS, suitable for local suppliers.
  • Concerns: May indicate a business is too small or lacks the resources to meet higher industry standards.

ISO 9001 (International Organization for Standardization 9001)

iso9001

ISO 9001 is an international standard for quality management systems that focuses on maintaining a consistent level of quality. The issue with this is it has no focus on quality. You can hold this accreditation if you have poor quality systems as long as you can do it consistently. 

 However, it has some limitations that businesses should be aware of.

  • Focus: Emphasises consistency in manufacturing processes rather than the quality of the end product.
  • Standard Level: Ensures that a manufacturer can repeatedly produce to a set standard, but this does not necessarily mean high-quality products.
  • Concerns: A manufacturer can consistently produce poor-quality products to the same standard, as the emphasis is more on the process than on the quality outcome.

 

ISO 14001 (International Organization for Standardisation 14001)

iso 14001

ISO 14001 is an international standard for environmental management systems, focusing on a company’s impact on the environment and how it manages this impact.

  • Focus: Environmental management and sustainability practices.
  • Standard Level: Ensures that a company implements effective environmental policies and practices.
  • Concerns: While important for demonstrating environmental responsibility, ISO 14001 does not address product quality or safety standards.

 

Food Hygiene Rating

food hygiene

The Food Hygiene Rating scheme assesses the hygiene standards of food premises, such as restaurants, cafes, and retail food outlets. This has no relevance to manufacturing at all. If a manufacturer is showcasing this, be wary.

  • Focus: Hygiene standards of food service and retail establishments.
  • Scope: Evaluates cleanliness, food handling practices, and structural conditions of premises.
  • Concerns: Not relevant to supplement manufacturing processes or product quality.

What accreditations do I need to sell my product?

Different sales channels may require your manufacturer to hold specific accreditations to sell your product. Understanding these requirements is essential for ensuring compliance and maintaining the trust of your customers. In this section, we will explore the necessary accreditations for various sales channels.

 

Direct to Consumer (D2C)

When selling products directly to consumers, there are no legal requirements for specific accreditations. However, you have a moral responsibility to ensure that your products are of the highest quality and safety standards. While not legally mandated, obtaining reputable accreditations can significantly enhance your product’s credibility and consumer trust.

Legal Requirements: None

Moral Responsibility: Ensuring high product quality and safety for your customers

 

Amazon

When selling products on Amazon, specific accreditation requirements vary depending on the region.

  • Europe:
    • Required Accreditation: Manufacturer must hold GFSI-recognised accreditations.
  • United States:
    • Required Accreditation: Manufacturer must hold NSF-recognised or NSF GMP certifications.

 

UK Retail

In the UK, retailers have their own audit teams to assess manufacturers. If you want to sell your product in their stores, these teams will conduct an audit on your product’s manufacturer. 

Typically, the manufacturer must hold a BRCGS certification before the retailer will consider performing their audit. Additionally, each retailer has its own set of specific requirements that must be met.

Consequences of not having the right accreditations

Choosing a manufacturer without the proper accreditations can have severe repercussions for your brand. Here are some of the key issues you may face:

 

  1. Retail Access and Online Sales:

Risk: Without the right accreditations, your products may not meet the stringent standards required by major retailers such as Tesco and Sainsbury’s. Additionally, online marketplaces like Amazon have strict quality and safety requirements.

Consequence: This can result in your products being rejected by these retailers, preventing you from reaching a broad customer base. In more severe cases, your brand could be blacklisted, significantly diminishing your market presence and leading to substantial financial losses. The inability to access these crucial sales channels means missing out on large volumes of potential customers and revenue.

 

  1. Allergen Contamination:

Risk: Manufacturers without robust allergen control policies and procedures may produce products that are inadvertently contaminated with allergens such as nuts, gluten, or dairy.

Consequence: This contamination can cause severe allergic reactions in consumers, which in extreme cases can be fatal. Beyond the tragic human cost, this can result in legal liabilities, product recalls, and irreparable damage to your brand’s reputation. Consumers may lose trust in your products, leading to a significant downturn in sales and long-term brand loyalty.

 

  1. Hazardous Contaminants:

Risk: Without proper accreditations, there is a higher risk that manufacturing processes are not adequately controlled, leading to contamination with hazardous substances like heavy metals (e.g., lead, mercury) or other toxic chemicals.

Consequence: The presence of these contaminants can pose serious health risks to consumers, including poisoning, chronic health conditions, and long-term health effects. This can trigger product recalls, lawsuits, and potentially hefty fines from regulatory bodies. The negative publicity associated with such incidents can severely damage your brand’s image and consumer confidence.

 

  1. Cross-Contamination in Sports Supplements:

Risk: Inadequate cleaning and cross-contamination controls can result in sports supplements being tainted with banned substances, such as steroids or other performance-enhancing drugs.

Consequence: Athletes consuming these contaminated products may fail drug tests, jeopardising their careers and reputations. This not only harms the individuals involved but also places your brand at the centre of a potential scandal. 

The fallout could include legal action, loss of endorsements, and a tarnished reputation within the sports community. Ensuring that your manufacturing processes are free from cross-contamination is essential for maintaining trust with sports professionals and their supporting organisations.

 

  1. Global Scaling Issues

Risk: Facing future scaling issues as your product may need to be sold in regions requiring accreditations that your original manufacturer does not hold.

Consequence: This limitation can hinder your ability to expand into new markets, forcing you to either remanufacture your product in a facility with the appropriate accreditations or potentially lose out on significant growth opportunities. 

This can lead to increased costs, delays in market entry, and the logistical complexities of finding and transitioning to new manufacturing partners. Ensuring your manufacturer holds the necessary global accreditations from the outset is essential for smooth and efficient market expansion.

 

  1. Product Recall

Risk: Manufacturing products without proper accreditations increases the risk of producing goods that do not meet safety and quality standards, potentially leading to widespread issues.

Consequence: If products fail to meet regulatory requirements or are found to be unsafe, you may face a product recall. This can result in significant financial losses, damage to your brand’s reputation, and loss of consumer trust. 

The logistics of a recall can be complex and costly, involving removing products from shelves, communicating with consumers, and addressing legal and regulatory repercussions. To avoid such costly and damaging scenarios, it is crucial to ensure that your manufacturing processes meet all necessary accreditation standards.

 

 

  1. Inconsistency

Risk: Lack of proper accreditations can lead to inconsistencies in product formulation, efficacy, serving size, and packaging.

Consequence: Inconsistent products can confuse and frustrate consumers, leading to a lack of trust in your brand. Variations in formulation and efficacy can result in some products being less effective or even potentially harmful, while inconsistencies in serving size and packaging can cause dosing errors. 

The cost of addressing these inconsistencies can be significant, involving re-manufacturing, re-packaging, and additional quality control measures. Furthermore, inconsistent products can lead to increased customer complaints and returns, ultimately affecting your bottom line and brand reputation. 

 

  1. Lack of traceability in ingredients

Risk: Without proper accreditations, manufacturers may lack robust systems for tracing the origin and handling of ingredients used in your products.

Consequence: This lack of traceability can lead to significant issues in quality control and safety assurance. If an ingredient-related problem arises, the inability to trace its source can delay corrective actions, potentially exacerbating the issue. Additionally, regulatory bodies require traceability to ensure compliance with safety standards. 

Failing to provide this can result in fines, legal action, and the necessity for a product recall. Ensuring that your manufacturer has comprehensive traceability systems in place through proper accreditations is crucial for maintaining product integrity and regulatory compliance.

What Accreditations does Supplement Factory Have?

At Supplement Factory we take pride in our quality system and work hard to ensure we hold the highest accreditations that we can. We understand that we have a responsibility to the public who will be consuming the supplements that we manufacture.

We currently hold:

 

BRC AA Grade

We hold an A* rating with the BRCGS, a prestigious recognition in the industry. The A* signifies that we achieved this grade during an unannounced audit.

 

NSF-GMP A Grade

We hold the highest accreditations available under NSF-GMP. This certification ensures that our products meet or exceed the quality and safety requirements set forth by the NSF. 

Furthermore, it means we are FDA approved, signifying that our manufacturing processes comply with the regulations and guidelines established by the U.S. Food and Drug Administration.

 

HACCP (Hazard Analysis and Critical Control Points)

HACCP is an integral component of both BRCGS and NSF-GMP standards. Since BRCGS and NSF-GMP both encompass HACCP within their comprehensive frameworks, we do not need to obtain a separate HACCP certification.

 

Halal

We hold halal certifications and can have any product certified as Halal. This certification ensures that our manufacturing processes, ingredients, and final products comply with Islamic law, making them suitable for consumption by Muslim customers. We have the capability to certify any product as Halal upon request. 

Supplement Factory

Written by Supplement Factory

Our team of industry experts not only work towards producing the highest standards of sports and health nutrition products, but also lend their knowledge towards educating the industry on the latest advances in products, ingredients and formulations.

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