GOOD DISTRIBUTION & STORAGE PRACTICES

1. Organization and management

2. Personnel
3. Quality system
4. Premises, warehousing and storage
5. Vehicles and equipment
6. Shipment containers
7. Documentation
8. Complaints
9. Recalls
10. Returned products
11. Contract activities
12. Internal quality audit
13. Self-inspection
14. Measurement, analysis and improvement
1. Organization and management
1.1 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.

1.2 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.

1.3 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.

1.4 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.

1.5 The organization shall give consideration to potential sources of contamination

from the local environment.

2. Personnel
2.1 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.
2.2 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.

2.3 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.

2.4 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.

2.5 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.

2.6 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.

2.7 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.

3. Quality system
3.1 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.

3.2 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.

3.3 Top management shall review the organization’s quality management system at
planned intervals to ensure its continuing suitability, adequacy and effectiveness.
This review shall take into consideration:
a. The status of actions from previous management review meetings;
b. Changes in external and internal issues that are relevant to the quality
management system;
c. Information on the performance and effectiveness of the quality management
system including trends in:
- Customer satisfaction and feedback from relevant interested parties
- Non conformities and corrective actions
- Warehouse performance and conformity of products and services
- Audit results
- The performance of external providers
d. The adequacy of resources;
e. The effectiveness of actions taken to address risks and opportunities;
f. Opportunities for improvement.

3.4 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.

international guidelines) by external bodies are recommended. Such certification

shall not, however, be seen as a substitute for compliance with these guidelines.

3.5 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.

Traceability of food supplement products

3.6 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.

3.7 The warehouse shall identify all parties involved in the supply chain, depending
on the product’s type and national policies and legislations.

3.8 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.
4. Premises, warehousing and storage
4.1 The warehouse shall ensure that storage areas 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 warehouse; to facilitate proper
stock rotation, particularly important in relation to short-life and date-marked food
supplement products; and to obtain maximum utilization of available space.

4.2 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.

4.3 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.

4.4 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.

4.5 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.

4.6 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.

4.7 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.

4.8 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.
4.9 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.

4.10 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.

4.11 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 and stock control

4.12 Storage conditions for food supplement products shall be in compliance with
the recommendations of the manufacturer.

4.13 Records of temperature and humidity monitoring data shall be available for
review. There shall be defined intervals for checking temperature.

4.14 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.

4.15 Periodic stock reconciliation shall be performed. Stock discrepancies shall be

investigated in accordance with a specified procedure.

5. Vehicles and equipment

5.1 There shall be procedures in place for the operation and maintenance of all
vehicles and equipment involved in the distribution process, including cleaning and
safety precautions.

5.2 All vehicles should be free from rodents, birds and insects or contamination from
them; free from odors, nails, splinters, oil and grease, accumulations of dirt and
debris, and should be in good repair, without holes, cracks or crevices that could
provide entrances or harborage for pests.

5.3 Prior to loading, it is advisable that the vehicle interior (including walls, floor and
ceiling) be inspected for general cleanliness, freedom from moisture foreign
materials which could cause product contamination or damage to the packages.

5.4 A procedure should be set up to deal with consequences of accidents and

damage occurring when food supplement products are in storage or distribution.

5.5 Security precautions should include means of deterring and preventing any
tampering with goods in storage and distribution.
5.6 Fork lift and other trucks used within the warehouse should normally be battery
driven or otherwise equipped to prevent fume or fuel contamination.

6. Shipment containers
6.1 The warehouse shall ensure that imported food supplement products are stored
and distributed in shipment containers that have no adverse effect on the quality of
the products, and that offer adequate protection from external influences, including
contamination.

6.2 Written procedures shall be available for the handling of damaged and/or broken
shipment containers.

7. Documentation
7.1 The warehouse shall establish appropriate documented procedures and
instructions related to all storage and distribution of food supplement products.

7.2 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.

7.3 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.

7.4 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.

7.5 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.

7.6 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.

8. Complaints
8.1 There shall be a written procedure in place for the handling of complaints. [1]
[5]

8.2 All complaints shall be reviewed according to written procedures describing the
action to be taken, including the need to consider a recall where appropriate.
Consideration shall be given to whether other batches of the product shall also be
checked.
8.3 Appropriate follow-up action shall be taken after investigation and evaluation of
the complaint. Complaints reports should be regularly analyzed, summarized and
reviewed. Results of the investigation of the complaint, shall be shared with all the
relevant parties.

9. Recalls

9.1 The warehouse shall put in place written withdrawal and recall procedures, and
these should be capable of being put into operation at short notice, at any time,
inside or outside working hours. These procedures shall be checked regularly and
updated as necessary.

9.2 The withdrawal and recall procedures should be shown to be practicable and
operable within a reasonable time by carrying out suitable testing of the procedure.

9.3 Recalled food supplement products shall be segregated and clearly labeled as
recalled products. They shall be stored in a secure, segregated area pending
appropriate action.

9.4 All concerned parties shall be informed promptly of any intention to recall the
product.

9.5 All records shall be readily available to the designated person(s) responsible for
recalls and shall contain sufficient information.

9.6 The progress of a recall process shall be recorded and a final report issued,
which includes reconciliation between delivered and recovered quantities of
products.

10. Returned products

10.1 The warehouse shall establish appropriate procedures for the management of
returned products in a way to ensure they are appropriately identified, segregated
and handled.

10.2 Food supplement products that shall be disposed shall be manipulated in

accordance with international, national and local requirements regarding disposal of
such products, and with due consideration to protection of the environment.

10.3 Where applicable, records of all returned, rejected and/or destroyed food
supplement products shall be kept for a predetermined period.

11. Contract activities

11.1 Any activity relating to the distribution and storage of food supplement
products which is delegated to another person or entity shall be performed by
parties appropriately authorized for that function and in accordance with the terms
of a written contract.

11.2 The contract shall define the responsibilities of each party including observance
of the principles of good distribution and storage practices.

11.3 All contract accepters shall comply with the requirements of these guidelines
and shall be audited periodically. Proof of audits shall be maintained.

12. Internal quality audit

12.1 The warehouse shall conduct internal audits at planned intervals to determine
whether the quality system conforms to planned arrangements, to the requirements
of the Good Storage and Distribution Practices of Food Supplement Products
guidelines and to the quality management system requirements established by the
warehouse. Internal audits allow also ensuring the quality system is effectively
implemented and maintained.

12.2 Internal audits shall be planned taking into consideration the status and
importance of the operations and areas to be inspected, as well as the results of
previous audits.

12.3 The internal audit criteria, scope, frequency and methods shall be determined.

12.4 The selection of internal auditors and conduct of internal audits shall ensure
objectivity and impartiality of the audit process.

12.5 A documented procedure shall be established to define the responsibilities and

requirements for planning and conducting internal audits, establishing records and
reporting results.

12.6 The results of all internal audits shall be recorded. Reports shall contain all
observations made during the audit and, where applicable, proposals for corrective
measures. There shall be an effective follow-up program. Management shall
evaluate the internal audit report and the records of any corrective actions taken.

13. Self-inspection
13.1 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.
13.2 Self-assessments shall be conducted in an independent and detailed way by a
designated competent person.

14. Measurement, analysis and improvement

14.1 The warehouse shall determine:
- What needs to be monitored and measured;
- The methods for monitoring, measurement, analysis and evaluation needed to
ensure valid results;
- When the monitoring and measuring shall be performed;
- When the results from monitoring and measurement shall be analyzed and
evaluated.

The warehouse shall evaluate the performance and the effectiveness of the quality
management system and shall retain appropriate documented information as
evidence of the results.
14.2 The warehouse shall apply suitable methods for monitoring and where
applicable, measurement of the quality management system processes. These
methods shall demonstrate the ability of the operations to achieve planned results.
When planned results are not achieved, correction and corrective action shall be
taken, as appropriate.