GMP for Nutraceuticals

1. GMP for Nutraceuticals
Guided By:
Dr. Pankaj P. Nerkar
(HOD Regulatory Affairs)
Presented By: Hitesh S.
Sonawane
Course:1st Yr M. Pharm
(Regulatory Affairs)
Roll no:- 112
R. C. Patel Institute of Pharmacy, Shirpur
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2. Content
What are Nutraceuticals?
Why are GMPs Important for
Nutraceuticals?
Key Components
GMP Regulation According to INDIA,
EU, USFDA.
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3. What are Nutraceuticals?
Nutraceuticals are food or food components that provide health benefits
beyond basic nutrition.
Examples include vitamins, minerals, herbs, enzymes, and probiotics.
They are often used to promote overall health, prevent disease, or
improve specific conditions.
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4. Why are GMPs Important for
Nutraceuticals?
Ensure product
quality, safety,
and efficacy.
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Build consumer
trust and
confidence.
2
Meet regulatory
requirements
and avoid legal
repercussions.
3
Maintain a
competitive
edge in the
market
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5. Key Components of GMP Guidelines for Nutraceuticals
Quality Management System (QMS): Establishes a framework for quality control throughout the
manufacturing process.
Facilities and Equipment: Ensures facilities are clean, well-maintained, and appropriate for production.
Personnel: Requires qualified and trained personnel to handle raw materials, production, and quality
control.
Raw Materials: Defines standards for sourcing, testing, and storing raw materials.
Production and Process Controls: Outlines procedures for manufacturing, packaging, and labelling to
ensure consistency and quality.
Documentation and Record keeping: Maintains accurate records of all processes and procedures for
traceability and audits.
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6. Facilities and
Equipment
• Adequate area for Manufacturing, Packaging,
Storage, and Lab testing.
• Distilled water.
• HVAC
• Lightening
• Equipment should meet desired quality
standard.
• DQ, OQ, IQ, PQ.
• Log-Book
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7. Personnel
• Qualified: Criteria based on
experience, education, and
training for the role.
• Trained : Continuous training
program for improvement.
• Health And Hygiene : SOP
describing requirement
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8. Quality
Assurance
There shall be a written document describing
the system of quality management to
established quality objectives.
All Process are performing according to
SOP.
Written Procedure for handling product
complaints.
Written procedure for identification,
documentation, review, and approval.
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9. Sanitation and Hygiene
Facilities and Equipment must be clean and sanitized to prevent
contamination.
Appropriate cleaning and sanitation procedure must be documented and
followed.
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10. Stability
Stability studies should be carried
out in at least three batches of the
same products.
The conditions of the stability
study and its duration should be
adequate to cover the storage,
distribution and usage of the
product.
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11. Records
Data should be
recorded by the person
who performed the
activity.
Data recorded should
be clear, legible.
Data should be sign by
authorised person.
For electronic records,
a system should be in
place for tracking and
for audit traceability to
identify at least
changes made.
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12. Recall
Recall for nutraceuticals involves the process of removing or correcting products that are found to be
unsafe or in violation for regulatory standards from the market.
Identification of an issue
Notification to regulatory authorities.
Disposal or Correction
Documentation and reporting.
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13. FSSAI (Food
Safety and
Standards
Authority of
India)
In India, nutraceuticals are regulated as per the Food
Safety and Standards Act, 2006, and the Food Safety
and Standards (Health Supplements, Nutraceuticals,
Food for Special Dietary Use, Food for Special
Medical Purpose, Functional Food and Novel Food)
Regulations, 2016.
FSSAI sets standards for ingredients, labelling, and
advertising of nutraceutical products.
Approval or registration with FSSAI may be required
depending on the type of nutraceutical product.
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14. • According to FSS regulation,2011
1) Registration of manufacturing site/manufacturing licence India is a necessary task to
market the food products in the country- Form A/B (obtaining from state licensing
authority except for those specified under schedule I)
2) For the Import purpose of any food/food product into the Country, the import license
must be obtained from the Central Licensing Authority.
• The Documents needed for the registration approval are,
1 -Application form A for registration
2 -Self-attested declaration form
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15. European GMP guidelines for nutraceuticals
Nutraceuticals fall under
the category of food
supplements in the EU.
Regulation (EU) no 2015/2283
Sets rules for the placing of food
supplements on the market,
including labelling requirements,
maximum and minimum levels
of vitamins and minerals, and
permitted sources of vitamins
and minerals.
The European food safety
authority (EFSA) evaluates
the safety and scientific
evidence for health claims on
food and supplements.
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16. FDA (United States)
In the U.S., nutraceuticals are regulated as dietary supplements under the Dietary
Supplement Health and Education Act (DSHEA).
The FDA regulates dietary supplements under a different set of regulations than those
covering conventional foods and drug products.
Firms are responsible for evaluating the safety and labelling of their products before
marketing to ensure they meet all the requirements of the Dietary Supplement Health
and Education Act of 1994.
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The Code of Federal Regulations (CFR) that pertains to nutraceuticals is found
in Title 21, Part 111.
Specifically, it is the Current Good Manufacturing Practice (CGMP) in
Manufacturing, Packaging, Labelling, or Holding Operations for Dietary
Supplements.
This regulation ensures that those involved in manufacturing, packaging, labelling, or
holding dietary supplements follow established practices to maintain the quality of
these products and adhere to specified packaging and labelling requirements.

18. References
GMP for Nutraceuticals .pdf (slideshare.net)
Food supplements - European Commission (europa.eu)
Compendium_Nutra_29_09_2021.pdf (fssai.gov.in)
Guidance & Regulation (Food and Dietary Supplements) | FDA
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19. Thank
You
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