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• Establishment – Personal Hygiene and Employee Facilities
• Establishment – Product Information and Consumer Awareness
• Establishment -Training and Management
• Establishment – Audit, Documentation and Record Keeping 2


Personal Hygiene and Employee Facilities

1. Health status, illness, and injury

• The employees in the health supplement manufacturing premises shall be inoculated against the

enteric group of diseases as per recommended schedule of the vaccine and a record shall be


• In health supplement manufacturing areas, personnel with open cuts, wounds or burns shall be

required to cover them with suitable water-proof dressings before starting operations

• Personnel known, or, suspected to be suffering from, or to be a carrier of a disease or illness

likely to be transmitted through health supplements, shall be prevented from handling health

supplements or materials which come in contact with health supplements.

• Health supplement/ Nutraceutical handlers of the manufacturing facility shall undergo a medical

examination by a registered medical practitioner before joining for work 3


2. Personal Cleanliness

• Health Supplement handlers shall maintain a high degree of personal cleanliness and shall wear
work clothing, head covering, and footwear that is fit for purpose, clean and in good condition
Workwear shall provide adequate coverage to ensure that hair, beards, moustaches, perspiration, etc.
cannot contaminate the product

• All people entering food processing, storage, distribution and handling areas shall wash their hands
with soap and potable water, followed by drying and sanitizing, where required:

I. before starting work;

II. after handling chemicals;

III. after handling incompatible food products.

IV. after breaks

V. after coughing or sneezing or blowing their nose; and fit for purpose 4


3. Work wear and Gowning

• Personnel who work in, or enter into, areas where exposed products or materials are handled
shall wear work clothing that is fit for purpose, clean and in good condition.

• Personal protective equipment, where required, shall be designed to prevent product
contamination and maintained in hygienic condition.

• Clothing mandated for health supplement/ Nutraceuticals protection or hygiene purposes
shall not be used for any other purpose

4.visitor control

• Organizations should implement and display visitor control policy.

• Visitor identity cards provisions should be in place to maintain control on visitor’s access into
restricted areas.

5. Personal Behaviour

• Personal effect such as jewelry, watches, pins, perfumes or other items should not be worn or
brought into food handling areas if they pose a threat to the safety and suitability of food 5


Product Information and Consumer Awareness

1.Product information and labelling

• All packaged food products shall carry a label and requisite information as per

provisions to ensure that adequate and accessible information is available.

• This should include information about handle, store, process, prepare and display the food
products safely and correctly and that identifies food allergens in the product as ingredient

• All incoming, in-process and finished products shall be suitably identified for product
identification, stage of processing, inspection and test status etc. so as to avoid their inadvertent

• Lot identification shall be done to facilitate traceability, product recall, effective stock rotation
etc. 6


2.Consumer awareness and complaint handling

• Information may be provided by labelling or other means, such as company websites,
education programmes and advertisements, and may include storage, preparation and serving
instructions applicable to the product.

• The Food Business shall have a system to handle product complaints with identified person or
people responsible for receiving, evaluating, categorizing, investigating and addressing

• Complaints shall be accurately categorized according to safety concerns and other regulatory

• Verification of customer satisfaction can be recorded after appropriate actions implemented.

• Regular complaint data analysis can be utilized to reduce future customer complaints 7


Establishment- Training and Management

1. Awareness and Responsibility

• All personnel shall be aware of their role and responsibilities to protect food from contamination.

• Food handlers shall have necessary skills and knowledge to handle food hygienically.

• Those who are handling chemicals and hazardous substances shall be trained in specific handling
procedures and techniques.

2. Training Programmes

• Suitable training shall be given for handling food.

• Required knowledge and skills in GHP and GMP for specific tasks also given.

• These training programmed given by trained and qualified person.

• These training programmes shall be delivered by qualified and trained
• A Training Program exists for all levels of the organization (i.e. part-time, full- time, temporary

staff, management, visitors, contract personnel).


• Training for each employee can cover the following:
❑ Skill Matrix of the employee, Gap analysis for training needs.
❑ Particular tasks relevant to the employee’s specific role.
❑ General good manufacturing practice.
❑ The importance of, and factors involved in, personal hygiene.
• Each new employee should receive training upon employment. This training should be repeated,

modified or extended as required.
• Training procedures define short and long-term training requirements, retraining, refresher training, as

well as the qualification steps (and experience level needed) for Trainers.

3. Instruction and supervision

• Managers and supervisors of food processes shall have necessary knowledge and skills in food hygiene
(GHP and GMP) principles and practices to be able to judge potential risks and take necessary action to
remedy deficiencies.

• Periodic assessments of the effectiveness of training, instructions programmes as well as routine
supervision and checks should be made to ensure that food hygiene and food safety procedures are
being implemented correctly and effectively by all personnel. 9


4. Refresher training
• Training programmed shall be routinely reviewed and updated wherever necessary.

• Systems shall be in place to ensure that food handlers remain aware of all procedures necessary to
maintain the safety and suitability of health supplements/ Nutraceuticals.

5. Management and supervision

• Persons engaged in manufacturing, packaging, labeling, or holding, or in performing any quality
control operations shall have the education, training, or experience to perform the assigned functions.

• The organization management shall ensure providing necessary trainings & resources to their
employees to develop food safety culture at plant site.

• Employees performing specialized job functions should be certified to a recognized industry standard
or governmental organization. Certification records shall be verified.

• Standard operating procedure for GMP systems compliance should be maintained and its compliance
shall be verified through records /checklists on routine basis. 10


Establishment – Audit, Documentation and Record Keeping


A Health supplement/ Nutraceuticals organisation shall undertake regular self inspections with a
defined frequency of at least once a year, in order to check the implementation and compliance
with GMP principles and to propose any required remedial actions.

These shall cover:




✓Quality control

✓Distribution of the products


✓Systems for dealing with complaints, withdrawals and recalls 11


• Competent person(s)/ External experts shall conduct the self-inspection in an independent way.
• It can include a check on absence of prohibitive substances in the raw materials.
• Agreed corrections and corrective actions shall be completed within a specified period of time.
• Records shall be maintained of the observations and shall be retained for a pre-determined period

of time.

2. Manufacturing Documentation and Records
The Manufacturing or Batch Records shall be checked at each level and approved by QA
Deviations shall be documented, justified and approved by QA.
Manufacturing or Batch Records shall include the following:
✓Bill of material (BOM), Manufacturing formula, Process flow chart.
✓Manufacturing Instructions, Packaging list, Packaging Instruction, Labels etc.,
✓Documentation for each significant step in the manufacturing process
✓Written procedures for production line start-up, shutdowns and change-overs well defined. 12


Following records shall be maintained by the FBO:

• Incoming materials checks–raw materials, ingredients, packaging materials Etc.
• Inspection and testing.
• Operational controls such as temperature, pressure, time etc.
• Product recall and traceability
• Storage
• Cleaning and sanitation
• Pest control
• Medical examination and health status
• Training
• Calibration
• Complaints and customer feedback
• Corrective and preventive actions
• Self-evaluation results 13