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Food Supplements and Nutraceuticals Course & Certification
Intermediate
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3 hours
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About
GMP for Food Supplements and Nutraceuticals provides a practical and risk-based overview of Good Manufacturing Practices applicable to the manufacture, handling, packaging, storage, testing, and distribution of food supplements and nutraceutical products while maintaining product quality, safety, consistency, traceability, and regulatory compliance.
This GMP for Food Supplements and Nutraceuticals Course & Certification provides essential knowledge on GMP principles, quality management systems, personnel hygiene, premises and equipment, sanitation, pest control, raw material control, supplier qualification, specifications, weighing and dispensing, manufacturing operations, in-process controls, contamination and cross-contamination prevention, allergen management, laboratory controls, sampling and testing, packaging and labelling controls, batch records, documentation, traceability, storage, transportation, complaints, product returns, deviations, non-conformances, CAPA, change control, internal audits, product release, and recall management. The course also explains risk-based quality management for supplements and nutraceuticals, including control of botanical ingredients, vitamins, minerals, extracts, probiotics, enzymes, and other specialised ingredients, together with the importance of identity, purity, strength, composition, and microbiological quality. Learners will understand how GMP controls should be applied throughout the product lifecycle and how documented procedures, appropriate specifications, validated or suitably controlled processes, trained personnel, effective quality oversight, and reliable records support consistent product quality and consumer safety. The course also covers supplier and contract manufacturer oversight, data and record integrity, investigation of quality issues, CAPA effectiveness, regulatory inspection readiness, and continuous improvement. Upon successful completion, learners receive a certification demonstrating their understanding of GMP principles and their practical application to food supplement and nutraceutical manufacturing and quality operations.
Who Should Enrol?
- Food Supplement and Nutraceutical Manufacturing Professionals
- Quality Assurance and Quality Control Professionals
- GMP and Regulatory Compliance Professionals
- Production and Manufacturing Managers
- Laboratory and Analytical Testing Professionals
- Product Development and R&D Professionals
- Regulatory Affairs Professionals
- Supplier Quality and Procurement Professionals
- Warehouse, Storage, and Distribution Professionals
- Auditors and Quality Systems Professionals
- Contract Manufacturing and Third-Party Supplier Management Professionals
- Anyone involved in the manufacture, quality, compliance, testing, storage, or distribution of food supplements and nutraceutical products
What you will learn
Build a strong understanding of food supplement and nutraceutical regulation, including product classification, permitted ingredients, composition requirements, food safety, quality systems, and regulatory responsibilities.
Learn practical approaches to formulation and compliance, including ingredient and supplier controls, specifications, identity testing, traceability, HACCP-based controls, manufacturing requirements, and risk-based quality management.
Develop practical knowledge of supplement labelling and claims, including nutrition and health claims, product information requirements, substantiation, consumer communications, and the regulatory differences between Great Britain, Northern Ireland, and the United States.
Gain an understanding of regulatory and governance frameworks for food supplements and nutraceuticals, including documentation, batch records, complaints, recalls, due diligence, regulatory inspections, training, and ongoing compliance management.
Course Syllabus
- 1.1 What the law calls a food supplement
- 1.2 It is food, not medicine, and what follows
- 1.3 Four territories, and a framework that is diverging
- 1.4 The medicinal borderline
- 1.5 Novel foods and the regulated products process
- 1.6 Putting the classification decision together
- 2.1 The instruments, and how to name them
- 2.2 Safety, traceability, withdrawal and recall
- 2.3 Registration, approval and products of animal origin
- 2.4 No statutory GMP: what sits there instead
- 2.5 Who enforces, and with what powers
- 2.6 Offences, penalties and the due diligence defence
- 3.1 Article 5 and the permanent procedure
- 3.2 Annex II: the statutory prerequisite standard
- 3.3 Hazard analysis for supplement processes
- 3.4 The seven principles worked through
- 3.5 Validation, verification, monitoring and review
- 3.6 Certification schemes and the legal baseline
- 4.1 Permitted vitamins, minerals and sources
- 4.2 Upper levels without statutory maxima
- 4.3 EU divergence on levels and botanicals
- 4.4 Article 8 and the restricted substances
- 4.5 Contaminants and pesticide residues
- 4.6 Botanicals: status, identity and adulteration
- 5.1 DSHEA and the scope of 21 CFR Part 111
- 5.2 Personnel, physical plant and equipment
- 5.3 The production and process control system
- 5.4 Records and the operational subparts, G to P
- 5.5 Part 117, registration and the export chain
- 5.6 Part 111 against Great Britain food law
- 6.1 The 100 per cent identity testing requirement
- 6.2 Certificates of analysis and supplier qualification
- 6.3 Choosing an identity method that fits the material
- 6.4 The 2015 New York action, taught accurately
- 6.5 Writing specifications that can be met
- 6.6 Laboratory operations that survive inspection
- 7.1 The master manufacturing record
- 7.2 The batch production record
- 7.3 In-process control, review and release
- 7.4 Deviations, investigations and material review
- 7.5 Retention, retrieval and inspection
- 7.6 Contract manufacture and the quality agreement
- 7.7 Auditing a contract manufacturer
- 8.1 The mandatory particulars of a supplement label
- 8.2 Claims in Great Britain
- 8.3 Claims in the European Union
- 8.4 Claims in the United States
- 8.5 Complaints
- 8.6 Withdrawal, recall and traceability
- 8.7 One quality system, more than one regime
- The decision points, from classification through to recall
- The eight failures that recur, and the control that prevents each
- One system, not three: building to the strictest requirement in each area
- Assigned rather than assumed ownership
- Keeping pace with permitted lists and restrictions that genuinely move
- 📘 Bonus: Food Supplements and Nutraceuticals eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with a framework that is moving in several places at once: the permitted vitamin, mineral and source lists, which left the Food Supplements (England) Regulations 2003 when Schedules 1 and 2 were omitted on 1 January 2010 and now sit in the Nutrition (Amendment etc.) (EU Exit) Regulations 2019, SI 2019/651, and which England, Wales and Scotland now amend separately while Northern Ireland applies European Union law under the Windsor Framework; the Food Standards Agency regulated products process, reformed with effect from 1 April 2025; restrictions made under Article 8 of assimilated Regulation (EC) 1925/2006, where the Great Britain and European Union positions have diverged; the status of 'on hold' botanical health claims, where Article 28(3) to (6) were omitted from the Great Britain text with effect from 31 December 2020 while departmental guidance still describes those claims as usable; Regulation (EU) 2023/915 on contaminants; and 21 CFR Part 111 and Part 117 as the Food and Drug Administration applies them.
Learn from Industry Experts
The content is written by practitioners in supplement quality, technical and regulatory roles, and is built directly on primary sources: the Food Supplements (England) Regulations 2003 and its Welsh, Scottish and Northern Ireland parallels; SI 2019/651; assimilated Regulations (EC) 178/2002, 852/2004, 1169/2011, 1924/2006 and 1925/2006 and Regulation (EU) 2015/2283; the Food Safety Act 1990 and the Food Safety and Hygiene (England) Regulations 2013; the Human Medicines Regulations 2012 and MHRA Guidance Note 8; Directive 2002/46/EC and Regulation (EU) 2023/915; and the United States framework of the Dietary Supplement Health and Education Act 1994, 21 CFR Part 111, 21 CFR Part 117 and the Federal Trade Commission's Health Products Compliance Guidance. Every requirement taught names its instrument or its guidance, and the course is explicit about which widely repeated industry claims have no traceable source.
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