The distribution of pharmaceutical products is an important component activity in the Supply chain and involves several players. It consists of procuring, holding, supplying, importing and exporting of pharmaceutical products.
Distribution activities are carried out by manufacturers, importers, wholesalers/distributors,retailers and other persons authorized to supply pharmaceutical products in the public and private sectors.
The Good Distribution Practice (GDP) guidelines forming the focus of this article are intended to help players in the supply chain of pharmaceutical products comply with NAFDAC Good Distribution Practice Regulations.
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What are the objectives of the GDP guidelines?
-The GDP guidelines prescribe the minimumrequirements for good distribution of pharmaceutical products.
– The GDP guidelines provides appropriate tools to assist all categories of distributors in conducting their activities in order to maintain the quality of pharmaceutical Products and prevent counterfeits from entering the legal supply chain.
-The guidelines are intended to help in minimizing the inherent risks in distribution such as mix-ups, adulteration, contamination, cross contamination and diversions.
What is the applicability scope of these guidelines?
-These guidelines apply to persons and entities involved in any aspect of the Distribution of pharmaceutical products from the manufacturing site to the point of sales or use.
– The guidelines apply but are not limited to governments at all levels, non- governmental organizations, public and private health and storage facilities, manufacturers of finished pharmaceutical products, importers, exporters, wholesalers/distributors,suppliers, pharmacy retailers.
– Some sections of these guidelines also apply to other entities involved in the distribution of pharmaceutical products such as clearing and forwarding agents, freighters and transporters.
– The guidelines also apply to distributors that are established or operating in Customs areas, such as free zones or free warehouses.
Which persons fall under the exemptions to the applicability scope of the guidelines?
-The guidelines do not apply to holders of Patent and Proprietary Medicine Vendors’ License (PPMVL) as the activities of this group are covered under Good Dispensing Practices.
-The document is to be used in conjunction with other existing relevant Pharmaceutical product statutes in the country. The good practices outlined Below are to be considered general guides, and they may be adapted to meet Individual needs as the distributor achieves compliance with regulatory Objectives.
What are the responsibilities assigned to relevant parties under the guidelines?
-All parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process from site of the manufacturer to the entity responsible for dispensing or providing the product to the patient.
-The principles of good distribution practice (GDP) are applicable both to pharmaceutical products moving forward in the distribution chain from the manufacturer to the entity responsible for dispensing or providing the product to the end user; and to products which are moving backwards in the chain such as it obtains in return and recall
-The principles of GDP are also applicable to donated pharmaceutical products.
-All distributors should apply due diligence with adherence to the principles of GDP, for example, in procedures relating to traceability and in recognition of security risks.
-All distributors should comply with the extant national legislations on pharmaceutical products.
-All distributors should be appropriately authorized and can be held accountable for all the activities that relate to the distribution of pharmaceutical products.
– Only entities which have marketing authorization for pharmaceutical products or their agents are entitled to import or export pharmaceutical products.
-Pharmaceutical products may be distributed within or to a country or territory if a marketing authorization or similar authorization has been granted, which allows the use of that pharmaceutical product in that country or territory.
-Holders of an authorization to distribute pharmaceutical products should obtain their supplies only from persons or entities which are in possession of the applicable authorization to sell or supply such products.
-Distributors or their agents should supply pharmaceutical products only to persons or entities which are themselves authorized to acquire such products either in terms of an authorization to act as a distributor or to sell or supply products directly to a patient .
What are some of the GDP principles highlighted in the guidelines?
-The correct distribution of pharmaceutical products relies upon people. For this reason, there must be sufficient number of competent personnel to carry out all tasks for which the distributor is responsible. Individual responsibilities should be clearly understood by employee and be recorded.
– There should be an adequate organizational structure defined with the aid of an organizational chart for each distributor. The responsibility, authority and interrelationships of all personnel should be clearly indicated.
– Duties and responsibilities should be clearly defined and understood by the individuals concerned and recorded as written job descriptions. The position of the superintendent pharmacist as required by law for the supervision of activities should be well defined.
-At every level of the supply chain, employees should be fully informed and trained in their duties and responsibilities.
-A designated person should be appointed within the organization, who has defined authority and responsibility for ensuring that a quality management system is implemented and maintained.
-Managerial and technical personnel must have the authority and resources needed to carry out their duties and to set up and maintain a quality management system, as well as to identify and correct deviations from the established quality management system .
-The responsibilities placed on any one individual should not be so extensive as to present any risk to product quality.
-There should be arrangements in place to ensure that management and personnel are not subject to commercial, political, financial, and other pressures or conflict of interest that may have an adverse effect on the quality of service provided or on the integrity of pharmaceutical products.
-Safety procedures relating to all relevant aspects including the safety of personnel and property, environmental protection and product integrity should be in place.
What are the provisions of the guidelines regarding personnel?
-Key personnel involved in the distribution of pharmaceutical products should have the ability and experience appropriate to their responsibility for ensuring that pharmaceutical products are distributed properly.
– Personnel involved in the distribution of pharmaceutical products should wear garments suitable for the activities that they perform.
– Personnel dealing with hazardous pharmaceutical products, including products containing materials that are highly active, toxic, and infectious or sensitizing, should be provided with Personal Protective Equipment (PPE) as necessary.
– Procedures and conditions of employment for employees, including contract and temporary staff, and other personnel having access to pharmaceutical products must be designed and administered to assist in minimizing the possibility of such products coming into the possession of unauthorized persons or entities.
– Codes of practice and punitive procedures should be in place to prevent and address situations where persons involved in the distribution of pharmaceutical products are suspected of, or found to be implicated in, any activities relating to the misappropriation, tampering, diversion or counterfeiting of any product.
– Appropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed. Such procedures should cover health, hygiene and clothing.
Who exactly is a “Responsible person” under the guidelines?
– All distributors under the guidelines must designate a person as a responsible person who is the superintendent pharmacist. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.
– The responsible person should fulfill their responsibilities personally and should be continuously contactable.
– The responsible person may delegate duties but not responsibilities.
– The written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. The distributor should give the responsible person the defined authority, resources and responsibility needed to fulfill their duties.
-The responsible person should carry out their duties in such a way as to ensure that the distributor can demonstrate GDP compliance and that obligations to the public are met.
-The responsibilities of the responsible person include:
a.Ensuring that a quality management system is implemented and maintained;
b.Focusing on the management of authorized activities, the accuracy and quality of records;
c.Ensuring that initial and continuous training programmes are implemented and maintained;
d.Coordinating and promptly performing any recall operations for pharmaceutical products;
e.Ensuring that relevant customer complaints are dealt with effectively;
f.Ensuring that suppliers and customers in the distribution chain are approved;
g.Approving any subcontracted activities which may impact on GDP;
h.Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
i.Keeping appropriate records of any delegated duties;
j.Deciding on the final disposition of returned, rejected, recalled or falsified products; k.Approving any returns to saleable/useable stock;
l.Ensuring that any additional regulatory requirements imposed on certain products are adhered to.
What are the provisions of the guidelines on training?
– All personnel involved in distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Training should be based on written standard operating procedures (SOPs).
-Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The responsible person should also maintain their competence in GDP through regular training.
– In addition, training should include aspects of product security, as well as aspects of product identification, the detection of counterfeits and the avoidance of counterfeits entering the supply chain.
-Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), as well as time and temperature-sensitive products.
– A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.