This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product. Contact me: www.linkedin.com/in/varsha-jindaniya

1. NEUTRACEUTICALS
PRESENTED BY
VARSHA JINDANIYA
PHARMACEUTICAL DEPT.
MIET COLLEGE MEERUT
A COMPARATIVE STUDY OF GMP GUIDELINES FOR
NEUTRACEUTICALS: INDIAN AND EUROPEAN

2. CONTENT
1. Introduction
2. Role of Nutraceuticals in human health
• Allergy and Nutraceuticals
• Alzheimer's disease and Nutraceuticals :
• Cancer and Nutraceuticals
• Immune system and Nutraceuticals
• Herbal medicines
3. Indian GMP guidelines for Neutraceuticals
• Registration process in India
• Documentation
• India’s good manufacturing practice (GMP) standards
• India quality control/quality assurance for medical devices
• India quality control/quality assurance for pharmaceuticals
4. European GMP guidelines for Neutraceuticals
• Quality control
• Documentation
• Production
• Validation
5. References

3. INTRODUCTION
A Nutraceutical product may be defined as a substance, which has
physiological benefit or provides protection against chronic disease.
Nutraceuticals may be used to improve health, delay the aging process,
prevent chronic diseases, increase life expectancy, or support the structure or
function of the body.
• Neutraceuticals increase the immunity and helps to strong immune
system.
• Neutraceuticals support the structure and function of the body.

4. ROLE OF NUTRACEUTICALS IN HUMAN HEALTH
Neutraceuticals are modifying and maintaining normal physiological function
that maintains human health.
Allergy and Nutraceuticals:
Allergy is a hypersensitivity disorder of the immune system. An allergic
reaction usually occurs when a person's immune system reacts to normally
harmless substances.
Alzheimer's Disease and Nutraceuticals:
Alzheimer's disease (AD) is the most common form of dementia. There is no
cure for the disease and eventually it leads to death. Most often, AD is
diagnosed in people over 65 years of age. Alzheimer is very dangerous
disease.

5. ROLE OF NUTRACEUTICALS IN HUMAN HEALTH

6. ROLE OF NUTRACEUTICALS IN HUMAN HEALTH
Cancer and Nutraceuticals:
• Current treatment for cancer including chemotherapy, radiotherapy, and
biologically based therapies .
• Lycopene is a naturally occurring chemical that gives red colour to the fruits
and vegetables . It is one of a number of pigments called carotenoids.
• β-carotene has antioxidant activity which prevents cancer and other diseases.
• Citrus fruit flavonoids are able to protect against cancer by acting as
antioxidants.
• Soybean gives the protection against breast, uterine, lung, colorectal, and
prostate cancers.
• Pectine, Glucosinolates and their hydrolysis products, Phenolic compounds,
and Curcumin these all are having the anticancer property.

7. ROLE OF NUTRACEUTICALS IN HUMAN HEALTH
Immune system and Nutraceuticals:
A wide variety of Nutraceuticals that belong to the category of immune boosters
are useful to improve immune function.
Garlic and morphine also are good example of the Nutraceuticals, which
respectively stimulate and suppress immune system.
Herbal Medicines:
The aim of herbal medicine to the body is natural balance so that it can heal
itself. Different herbs act on different systems of the body. Some herbs that are
commonly used in the herbal medicine, and their traditional uses, include:

8. ROLE OF NUTRACEUTICALS IN HUMAN HEALTH
Herbal Medicine:
Dong quai (dang gui) – used for gynaecological complaints such as premenstrual
tension, menopause symptoms and period pain.
Garlic – used to reduce the risk of heart disease by lowering the levels of blood
fats and cholesterol (a type of blood fat).
Ginger – Ginger is to be useful in treating nausea, including motion sickness and
morning sickness. It can reduce the risk of diabetes, and may lower the risk of
cancer.
Ginseng – generally used to treat fatigue, for example during recovery from
illness. It is also used to reduce blood pressure and cholesterol levels.

9. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
Indian Neutraceutical market:
There are several India Neutraceutical market is subdivided into two groups:
1. Functional foods and beverages (60 %)
• Functional foods (fortified foods)
• Functional beverages (fortified juices, energy drinks sports drinks)
2. Dietary supplements (40%)
• Vitamins and mineral supplement
• Herbal supplement
• Protein supplement
• Chyawanprash

10. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
Registration of Dietary supplement in India:
In India the registration of Nutraceutical is required for the marketing of
the product in Indian market. The FSS act (2006) gives the procedure for
the registration of the Nutraceutical products, but there is no standard format
is available for the purpose. The Nutraceutical companies in India struggles a
lot for the approval of the product due to the lack of the proper roadmap for
the registration of the products. FSSAI issued the Food safety and standard
rules, 2011 in May of 2011.
This rules gives the regulations for licensing and registration of food products,
food business, packaging and labelling methods, standards for food products
and additives used in the food product.

11. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
According to FSS regulations, 2011,
1. Registration of manufacturing site/manufacturing license in India is a
necessary task to market the Food products in the Country - Form A/B
(obtained 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,
• Application form A for registration
• Self-attested declaration form

12. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
License for manufacturing/ import license –
• Application Form B of Schedule 2 and license obtained in form C
• Self-attested declaration form
• Copies of the following documents
The Food Safety Standard Authority India (FSSAI) is the approving authority
which grants the approval for the registration of the food products and food
business for the sale of the products in the country. It also promotes the general
awareness of the food safety standards in the country.

13. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
Documentation
Documents to be enclosed with new application for license or import license to
State or Central Licensing Authority.
• Form-A
• Form B
• Blueprint or layout plan of the processing unit
• List of Directors
• Name and List Machineries to be used in the process
• Photo I.D and address proof
• List of food category desired to be manufactured.
• Authority letter with name and address of responsible person
• Analysis report

14. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
Documentation
• Partnership deed/Affidavit/Memorandum & Articles
• NOC from manufacturer
• Food safety management system plan or certificate
• Source materials
• Pesticide residues report of water
• Recall plan
• NOCs

15. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
India’s Good Manufacturing Practice (GMP) Standards:
India’s GMP standards for medical devices and drugs are covered in Schedule M
and Schedule M III of the Drugs and Cosmetics Act (DCA):
• Schedule M describes the quality assurance, self-inspection and or quality
audit, and quality control system requirements for medical devices and
pharmaceuticals; it also lists the requirements for the factory premises,
materials, plant, and equipment.
• These requirements are based on the (WHO) World Health Organization
guidelines.
• For drugs, there are also additional specific requirements for small volume
injectables, large volume parenterals, APIs, tablets, capsules, etc.
• India’s GMP regulations are now more aligned with ISO 13485. Standardizing
quality requirements will help manufacturers in India register their medical
devices more effectively.

16. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
India Quality Control/Quality Assurance For Medical
Devices:
Depending on the type of the medical device, the Drug Controller General of
India (DCGI) and the State FDA will approve or determine the medical device
licensing process.
The application for a manufacturing license may include manufacturing
processes, product details, and information about the staff. In addition, there are
many state and local level licenses that are needed to manufacture a medical
device. Therefore, understanding the regulations of a particular Indian State is
important when deciding on a manufacturing site location.

17. INDIAN GMP GUIDELINES FOR NEUTRACEUTICALS
India Quality Control/Quality Assurance For
Pharmaceuticals:
Quality management systems in India should ensure that compliance with India
GMP, GLP (Good Laboratory Practice), and GCP (Good Clinical Practice). The self-
inspection and the quality audit should be an evaluation of the GMP compliance
with a team of in-house and or external experts to audit the implementation and
document changes made. The quality control system should include the
sampling, specifications, testing, documentation, release procedures, etc.
Under the Drugs and Cosmetics Act of 1940, all drug manufacturing are require a
license. This license can only be given to an entity based in India.

18. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Food supplements that are marketed in a EU Member State have to comply with
all relevant aspects of EU food legislation and any specific EU Member State
national legislation in terms of their composition, manufacture and control.
The aim of this document is to produce guidelines which address the specific
needs of the food supplement industry in relation to good manufacturing
practice, with special attention paid to the requirements of EU food legislation.
The EU legal requirements on food hygiene apply also to food supplements that
are manufactured in a EU Member State for direct export to countries outside of
the EU.
Good manufacturing practices (GMP) are an important part of a comprehensive
system of quality assurance.The pharmaceutical industry of the European Union
(EU) maintains high standards of Quality Management in the development,
manufacture and control of the medicinal products.

19. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Quality Control
The requirements of the WHO regarding Quality Control as the part of GMP
concerned with sampling, Again only minor differences could be observed
between the two guidelines, e.g.:
• The WHO accented the independence of the Quality Control department;
• The WHO included under point 17.4.c again “qualification” not only
“validation”;
• The EU guidelines emphasise the need to release products through a
Qualified Person (based on EU drug law).

20. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Quality Control
The tasks of quality control are beside others:
• Sampling,
• Stating of specifications,
• Execution of tests, as well as
• Organisation and documentation of release methods.
In order to be able to execute these tasks in accordance with the requirements,
the Quality Control has to be kept separate from the production.

21. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Quality Control
Ad “Product Quality Review” and ad “Quality Risk Management”
“Product Quality Review” and “Quality Risk Management”.
The EU guidelines additionally mentioned the need to compile Product Quality
Reviews as well for Marketing Authorisations for third countries.

22. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Documentation
According to the motto “not written, not done”, a good documentation praxis is
closely linked to the implementation of a GMP system. Intelligible and detailed
instructions and records are basic requirements for the production of medicinal
products on a high quality level.
Specifications:
• Manufacturing formulas / master formulae,
• Packaging instructions,
• Batch processing records,
• Batch packaging records,
• Procedures /standard operating procedures and records decisive differences
can be detected.

23. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Production
The production of medicinal products on a continuously high quality level require
the existence of a detailed process description based on the respective
manufacturing and the relevant Marketing Authorisation.
Prevention of cross-contamination in production:
• Validation,
• Starting materials,
• Processing operations: intermediate and bulk products,
• Packaging materials,
• Packaging operations,
• Finished products,
• Rejected, recorded and returned materials.

24. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Validation
Validation and qualification processes are essential parts of modern good
manufacturing practice.
Validation is defined as the action of proving that any procedure, process,
equipment, material, activity or system actually leads to the expected results,
whereas qualification is any action of proving that any premises, systems and
items of equipment work correctly.

25. EUROPEAN GMP GUIDELINES FOR NEUTRACEUTICALS
Validation
The documents that cover the different areas of validation processes. These are
in detail:
Appendix 1. Validation of heating, ventilation and air-conditioning systems
Appendix 2. Validation of water systems for pharmaceutical use
Appendix 3. Cleaning validation
Appendix 4. Analytical method validation
Appendix 5. Validation of computerised systems
Appendix 6. Qualification of systems and equipment
Appendix 7. Non-sterile process validation

26. CONCLUSION:
The European union has amended the rules for importing the medicinal
products and substances for human use. comparison of the Indian registrations
with EU GMP regulations was done to determine whether they are equivalent
and determine the difference as per study there are different types of rules and
regulations in India and EU. Indian GMP guidelines and EU GMP guidelines both
are different from each other and the Indian regulations from EU's GMP Part 2
/ICH Q7. The website "Drug Regulations" has made a very extensive comparison
of the respective GMP regulations. This comparison clearly shows that the Indian
GMP guidelines are much more comprehensive and detailed in many areas than
the European GMP regulations.

27. THANK YOU