STARTING A SUPPLEMENT MANUFACTURING COMPANY

1. INTRODUCTION:

A Food supplement is defined under European and US  legislation as ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders’.

As food supplements are designed to supply nutrients, particularly micronutrients, and other nutritional or physiologically active substances in predetermined amounts, specialist skills and equipment are generally used in the manufacture of the majority of such products.

The aim of this document is to produce guidelines which address the specific needs to start the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU and US food legislation. It covers the complete cycle of starting manufacturing and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. 

All businesses along the food supplement supply chain should ensure that the relevant sections are complied with. For example, distributors should undertake audits on the manufacturers to ensure compliance with good manufacturing practice.

Manufacturers and distributors of food supplements should comply with all relevant EU, US and specific national legislation in their home country and also that of any countries to which they export their products. 

Following are the essential requirement to start Supplement manufacturing company.

2. PREMISES:

GENERAL REQUIREMENTS FOR PREMISES

Buildings should be located, designed, constructed, adapted and maintained to suit the operations carried out in them and to facilitate the protection of materials and products from contamination or deterioration.

• Premises must be designed to allow cleaning and maintenance to be carried out to a high level.
• Layout, design, construction and size should be such as to: 
  
  • permit hygienic cleaning, good hygiene practices, and suitable temperature/humidity conditions where necessary; 
  • prevent cross contamination in the premises and contamination from external sources such as pests
• Facilities that must be provided: 
  
  • ventilation; 
  • lighting; 
  • adequate supply of potable water; 
  • drainage facilities; 
  • washbasins and lavatories; 
  • changing facilities for staff.

GENERAL REQUIREMENT FOR ROOMS:

• Construction and design. 

The following surfaces and fittings must be smooth, free of crevices and easy to clean: 

• floor surfaces; 
• wall surfaces (including any horizontal surfaces); 
• ceilings and overhead fixtures; 
• windows; 
• doors; 
• surfaces in contact with raw materials, intermediate product or finished product. 

• Facilities. 

Adequate facilities must be provided for the cleaning, disinfecting and storage of tools and equipment where necessary. These facilities should be constructed of corrosion-resistant materials, be easy to clean and have an adequate supply of hot and cold water.

• Floors, walls and ceilings

Floors in manufacturing areas should be of adequate construction and material for the wear and tear and conditions of manufacture encountered and should: 

• be made of impervious and non-absorbent materials; 
• be laid to an even surface; 
• be free from cracks and open joints in areas where product is exposed; 
• have drains of adequate size with trapped gullies and proper ventilation; any open channels should be shallow to facilitate cleaning. 

Walls in manufacturing areas should be constructed from materials that avoid tainting or otherwise contaminating the product and should: 

• be intact and free of faults such as cracks, flaking etc.; 
• be finished with a smooth impervious and easily cleaned surface; 
• have any windows constructed from toughened glass or plastic; these should: 
• be adequately screened and secured; 
• have any ledges sloped away from the glass at an angle, to prevent items being left on them; 
• have all doors constructed with smooth, non-absorbent surfaces to facilitate easy cleaning and disinfection, when necessary. 
• Ceilings should be so constructed and finished that they can be maintained in a clean condition. In particular, suspended ceilings and overhead fixtures must be constructed and finished so as to prevent the accumulation of dirt and to reduce condensation, the growth of undesirable mold and the shedding of particles. 
• The coving of junctions between walls, floors and ceilings in critical areas is recommended.

• Cleaning and site hygiene 

All operations should be carried out in such a way that the risk of contamination of one product or material by another is minimized. 

It is recommended that a Site Hygiene Plan be established appropriate to the manufacturing operation. The Site Hygiene Plan should be regularly reviewed and amended when deemed necessary, in order to maintain a hygienic manufacturing site. The Plan should include written cleaning procedures and schedules for: 

• manufacturing and storage areas; 
• receiving and dispatch areas; 
• personnel hygiene facilities; 
• vehicles and containers used for transport and distribution 
• external premises.
• Waste 

Waste material should not be allowed to accumulate in the manufacturing, storage or other areas. It should be collected in suitable, clearly identifiable, receptacles for removal to specific collection points outside the buildings, and disposed of at regular and frequent intervals. The use of a specific colour, which is immediately recognizable within the company, is recommended for the waste containers.

• Receiving and dispatch areas 

Receiving and dispatch areas should: 

• Provide protection from the weather for materials or product in transit; 
• Provide a defined deboxing/debagging area for raw materials or packaging materials that arrive in external packaging. 

3. EQUIPMENT:

Equipment should be so designed and arranged as to protect the contents from external contamination and should not endanger a product through contamination from leaking joints/glands, lubricant drips and the like, or through inappropriate modifications or adaptations.

• Equipment maintenance and servicing:

Preventive maintenance should be considered for all equipment and components. A maintenance procedure should be developed.

• Calibration of equipment 

Regular calibration of all measuring equipment (weight, volume, temperature, etc.) should be carried out using appropriate standards.

4. WATER SUPPLY 

Potable water should be used for all manufacturing purposes and, where applicable, should be periodically analyzed according to the requirements of any national legislation. Certain operations may require higher standards of water, e.g. de-ionized water.

5. QUALITY MANAGEMENT SYSTEM

1. 1. QUALITY BY DESIGN:

Quality by design should start with the formulation and selection of raw materials and the choice of an appropriate manufacturing process and packaging materials. Each stage in a product’s development.

1. 1. GOOD MANUFACTURING PRACTICES:

all manufacturing processes are clearly defined, and known to be capable of achieving the desired ends; 

all necessary resources and facilities are provided, including: 

appropriately trained personnel 

adequate premises and space 

suitable equipment and services

correct materials, containers and labels 

approved procedures (including cleaning procedures suitable storage and transport)

operators are trained to carry out the procedures correctly.

1. 1. QUALITY ASSURANCE:

The fundamental aim of Quality Assurance is reproducibility, so that the product sold to the consumer is always within the agreed quality measure and as near identical as possible.

Quality Assurance generally involves the following: 

1. 1. • procedures are written in instructional form, in clear and unambiguous language, and are specifically applicable to the facilities provided; 
      • the monitoring of the Quality Assurance procedures of suppliers of raw and packaging materials, with regular audits where possible; 
      • the development of a Supplier Quality Assurance procedure, laying down the criteria for selection, approval, review and ongoing approval, to ensure that the supplied products and services meet the manufacturer’s requirements; 
      • records are made during manufacture (including packaging), which demonstrate that all the steps required by the defined procedures were in fact taken, and that the quantity and quality produced were those expected; 
      • records of manufacture and distribution, which enable the complete history of a lot (batch) to be traced, are retained in a legible and accessible form; 
      • a system is available to withdraw or recall from sale or supply any lot or product, should that become necessary; 
      • rapid feedback of information to manufacturing personnel, e.g. as summaries of quality performance data and related advice, as appropriate, to enable rapid modification or corrective action to be taken when required; 
      • rapid feedback of information to the purchasing department with regard to any concerns of quality relating to purchased materials, e.g. raw materials, packaging materials etc.; 
      • the examination of samples relating to customer/consumer complaints, with accompanying investigation of any causes of defects, where feasible, and the necessary steps advised for corrective action to be taken to prevent recurrence 
      • changes to relevant legislation are noted and applied where applicable, particularly legislative amendments to compositional standards or labelling requirements, which may require adjustments to specifications for raw materials or finished products.
   2. Quality Control:

Quality Control is the obligation to have in place an effective monitoring system that verifies compliance with specified requirements and parameters, and defines suitable corrective action in the event of non-compliance. As with Quality Assurance, Quality Control must be an ongoing process to ensure that quality of the product is maintained. 

To achieve effective control of quality: 

• • • • there should be a clear delineation of the relevant authorities and responsibilities of the Production Management and the Quality Control Management functions, to prevent any confusion or misunderstanding; 
      • ideally, the Quality Control Management and the Production Management should be on separate reporting structures; 
      • the Quality Control Management should have the authority to make independent decisions on the product quality; 
      • adequate facilities and staff should be available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk and finished products, and where appropriate, for determining environmental quality; 
      • samples of starting materials, packaging materials, intermediate products, bulk products and finished products should only be taken by authorized personnel and using methods approved by the person responsible for Quality Control; 
      • results of the inspection and testing of materials, and of intermediate, bulk or finished products, should be formally assessed against specification by the person responsible for Quality Control (or a person designated by him) before products are released for sale or supply; 
      • product assessment should include a review and evaluation of relevant manufacturing (including packaging) documentation; 
      • sufficient reference samples of starting materials and finished products should be retained (the latter in the final pack for the finished product) to permit future examination if necessary.
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•  6. PERSONNEL: 

Compatible with the size and type of business there should be sufficient personnel at all levels with the ability, training experience and, where necessary, the professional and technical qualifications, appropriate to the tasks assigned to them. Their duties and responsibilities should be clearly explained and recorded as job descriptions or by other suitable means. Deputies/delegates should be appointed and appropriately trained to cover the absence of key personnel; these positions should be formally authorized and documented.

7. MANUFACTURING:

Before start manufacturing essential material must be available.

1. 1. Raw material:

Each raw material/ingredient should have and be in compliance with its specification.

1. 1. Packaging and labelling materials:

Each packaging material should have and comply with its specification (including any legal requirements),

1. 1. Processing:

Particular care should be taken, in terms of production layout and practices, to avoid cross-contamination of one product by another. Multiple packaging lines should be adequately segregated to avoid the risk of cross-contamination. 

Before production begins, checks should be carried out to ensure that: 

• • • • the name and appropriate reference to the product being processed/packaged is clearly displayed on each production line; 
      • the production area is clean and free from any products, product residues, waste material, raw materials, packaging materials or documents not relevant to the production to be undertaken; 
      • the correct materials and documents have been issued; 
      • the correct machine settings have been made; 
      • all plant and equipment are clean and ready for use.
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    • 8. STORAGE:
      

Effective storage operations should be designed to ensure the following: 

• • • • that all products are easily accessible for load assembly as required; 
      • that aisles and assembly areas are planned so that unimpeded movement is possible to and from all parts of the storage area; 
      • to facilitate proper stock rotation such as first in first out, particularly important in relation to short-life and date-marked products; 
      • to obtain maximum utilization of available space, consistent with the above requirements. 

Storage and transportation of finished products should be under conditions that will: 

1. 1. • • prevent contamination, including development of pathogenic or toxigenic micro-organisms; 
        • protect against undesirable deterioration of the product and the container; 
        • assure the delivery of safe, clean and wholesome products to consumers.

Storage area temperatures should be kept at an appropriate level to maintain the wholesomeness of the particular products received and held in such areas.