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 1
- 2. Content What are Nutraceuticals? Why are GMPs Important for Nutraceuticals? Key Components GMP Regulation According to INDIA, EU, USFDA. 2
- 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. 3
- 4. Why are GMPs Important for Nutraceuticals? Ensure product quality, safety, and efficacy. 1 Build consumer trust and confidence. 2 Meet regulatory requirements and avoid legal repercussions. 3 Maintain a competitive edge in the market 4 4
- 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. 5
- 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 6
- 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 7
- 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. 8
- 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. 9
- 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. 10
- 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. 11
- 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. 12
- 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. 13
- 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 14
- 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. 15
- 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. 16
- 17. 17 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 18
- 19. Thank You 19