A Food supplement is defined under 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.
Therefore, as they are designed to supply nutrients, micronutrients and other physiologically active substances, their adequate distribution and storage is a crucial activity to maintain their quality and integrity and to protect consumers from potential health risks and to ensure that they are not provided with misleading information.
This article is intended to provide guidelines for the promotion of best practices in the storage and distribution of food supplements. Furthermore, it sets out appropriate steps to assist in fulfilling the responsibilities involved in the different aspects of the distribution process within the supply chain and to avoid the introduction of counterfeits food supplement products into the marketplace via the distribution chain.
The Ministry of Public Health of each countries stresses the importance of adhering to this guideline by all parties involved in any aspect of the storage and distribution of food supplement products, as relevant to the particular role that they play, from the premises of the manufacturer of the product to the person dispensing or providing food supplement products directly to a consumer or his agent.
There shall be an adequate organizational structure for each entity, defined with the aid of an organizational chart that clearly identifies responsibilities, authorities and interrelationships of all personnel.
Duties and responsibilities shall be clearly defined through documented job descriptions and understood by the concerned individuals, who shall be trained on their respective duties and responsibilities and who shall be aware of the relevance and importance of their activities and how they contribute to the achievement of the warehouse quality objectives and policy.
A designated competent person shall be appointed within the warehouse, who has defined authority and responsibility for ensuring that a quality system is implemented and maintained. He shall be accountable on reporting to top management on the performance of the quality management system and any need for improvement and ensuring the promotion of awareness of customer requirements throughout the warehouse.
The organization shall design, construct and maintain buildings in a manner appropriate to the nature of the operations. Buildings shall be of durable construction which presents no hazard to the product.
The organization shall give consideration to potential sources of contamination from the local environment.
The warehouse shall determine the necessary competence of personnel involved in the storage and distribution activities, doing work that affects the performance and effectiveness of the quality management system.
All personnel involved in the storage and distribution activities shall be competent on the basis of appropriate education, training, skills and experience in the requirements of good distribution and storage practices of food supplement products, as applicable. The warehouse shall provide necessary training to achieve needed competency.
The warehouse shall assess personnel performance in line with their job descriptions and shall take appropriate measures, detecting and providing necessary training needs to achieve needed competency.
Personnel training shall be based on written standard operating procedures (SOPs). They shall receive initial and continuing training relevant to their tasks, in accordance with a written training program and they shall be assessed as applicable to evaluate the effectiveness of the actions taken. Appropriate records shall be maintained, including details of subjects covered and participants trained.
Delivered trainings shall cover the topic of good storage and distribution practices, as well as aspects of product identification, the detection of counterfeits and the avoidance of counterfeits entering the supply chain.
Appropriate procedures relating to personnel hygiene and safety, relevant to the activities to be carried out, shall be established and observed. Such procedures shall cover health and safety, hygiene and clothing of personnel.
Codes of practice and punitive procedures shall be in place to prevent and address situations where persons involved in the distribution of food supplement products are suspected of, or found to be implicated in, any activities relating to the misappropriation, tampering, diversion or counterfeiting of any product.
There shall be a documented quality policy describing the overall intentions and requirements of the warehouse regarding quality, and including a commitment to comply with those requirements and continually improve the effectiveness of the quality system, as formally expressed and authorized by management. This policy shall be communicated and understood by all personnel.
The warehouse shall conduct a hazard analysis to assess potential hazards to the quality and integrity of food supplement products. The quality system shall be developed and implemented to address any potential risks identified. The quality system shall be reviewed and revised periodically to address new hazards identified during the hazard analysis.
Top management shall review the organization’s quality management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness.
Records from management review shall be retained. The outputs of the management review shall include decisions and actions related to opportunities for improvement, any need for changes to the quality management system and resource needs.
Inspection, auditing and certification of compliance with a quality system (such as the applicable International Standardization Organization (ISO) series, or national or international guidelines) by external bodies are recommended. Such certification shall not, however, be seen as a substitute for compliance with these guidelines.
The warehouse shall foster a safe, transparent and secure distribution system which includes product traceability throughout the supply chain. There shall be procedures in place to ensure traceability of products received and distributed in order to facilitate product recall.
The warehouse shall identify all parties involved in the supply chain, depending on the product’s type and national policies and legislations.
Measures shall be in place to ensure that food supplement products have documentation that can be used to permit traceability of the products throughout distribution channels from the manufacturer/importer to the entity responsible for selling or supplying the product to the consumer or to the agent. Records including expiry dates and batch numbers may be part of a secure distribution documentation enabling traceability.
Storage areas shall be designed or adapted to ensure appropriate and good storage conditions. In particular, they shall be clean and dry and maintained within acceptable temperature limits. Food supplement products shall be stored off the floor and suitably spaced to permit cleaning and inspection.
Storage areas should be regularly inspected for cleanliness and good housekeeping, and to identify lots of products which have exceeded their shelf-life or, in the case of date-marked products, leave insufficient time for retail display. These inspections should be formally documented, including any corrective action taken if necessary.
Pallets shall be kept in a good state of cleanliness and repair. They should be checked periodically for structural integrity. Where appropriate, corner boards should be positioned at the corner of each stack, both to make the corner ‘stand out’ visually, and to protect the product from accidental impact damage by high lift and powered pallet trucks. Pallets should be placed in prescribed places and be so spaced as to allow proper ventilation.
Storage areas shall be provided with adequate lighting as high as possible above the product; the smaller the angle of light source from ground level, the smaller is the shadow made by the stack. Lights should be protected by shatterproof covers where appropriate.
The warehouse shall ensure that premises and storage areas undergo regularly a pest control program or must ensure that pest control activities are subcontracted to a specialized entity followed up regularly.
Precautions must be taken to prevent unauthorized persons from entering storage areas and precautions. A suitable curtain should be provided at all entrances and exits in order to maintain the internal conditions of the warehouse at an appropriate level for the product therein.
The warehouse shall establish a procedure to identify the potential for emergency situations (such as firefighting, flooding and other emergencies) and to respond to such emergency situations. This procedure shall be tested and reviewed periodically where practical.
Receiving and dispatch bays shall protect food supplement products from the weather. Receiving areas shall be designed and equipped to allow incoming containers of food supplement products to be cleaned, if necessary, before storage.
All stored items should be marked with their identification to ensure that traceability is maintained. Products which have been recalled or returned or identified damaged shall be marked and physically segregated, preferably in an entirely separate storage facility.
A system shall be in place to ensure that the food supplement products due to expire first are sold and/or distributed first (first expiry/ first out (FEFO)).
Storage conditions for food supplement products shall be in compliance with the recommendations of the manufacturer.
Records of temperature and humidity monitoring data shall be available for review. There shall be defined intervals for checking temperature.
The equipment used for monitoring shall be checked at suitable predetermined intervals and the results of such checks shall be recorded and retained. Temperature mapping shall show uniformity of the temperature across the storage facility.
Periodic stock reconciliation shall be performed. Stock discrepancies shall be investigated in accordance with a specified procedure.
The warehouse shall establish appropriate documented procedures and instructions related to all storage and distribution of food supplement products.
The title, nature and purpose of each document shall be clearly stated. The contents of documents shall be clear and unambiguous. Documents shall be laid out in an orderly fashion and be easy to check. Where a document has been revised, systems should be operated to prevent inadvertent use of superseded documents.
All documents shall be completed, approved, signed (as required) and dated by an appropriate authorized person(s) and shall not be changed without the necessary authorization.
Procedures shall be established and maintained for the editing, review, approval, use of and control of changes to all documents relating to the distribution and storage activities. Procedures must be in place for both internally generated documents and those from external sources.
All records must be readily retrievable, and be stored and retained using facilities that are safeguarded against unauthorized modification, damage, deterioration and/or loss of documentation.
The warehouse shall ensure appropriate backup systems for electronic documents and records. The server room shall also be appropriated maintained to prevent any data loss.
The warehouse shall conduct a self-assessment of its operations in order to monitor implementation and compliance with the principles of the good storage and distribution practices of food supplement products and if necessary, to trigger corrective and preventive measures.
Self-assessments shall be conducted in an independent and detailed way by a designated competent person.
The results of the self-assessment shall be recorded in the self-assessment sheets and sheets shall include all observations and relevant evidences detected during the assessment and where applicable, proposals for corrective measures shall be submitted. An effective follow up program shall be in place.
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