Good Storage and Distribution Practices in Zimbabwe
In order to address risks inherent in the supply chain of medical products the World Health Organisation (W.H.O.) introduced Good Distribution Practices (GDP) guidelines in 2005. W.H.O. revised the GDP guidelines towards the end of 2020. Effective 28 July 2021, the Medicines Control Authority of Zimbabwe (MCAZ) localised the revised GDP guidelines. The GDP guidelines are applicable to all parties involved in different stages of the supply chain of medical products from health logisticians, logistics services providers, transport companies, forwarding and clearing agents and their employees.
Access to Medicines
According to WHO Universal Health Coverage can only be achieved when there is affordable access to safe, effective and quality medicines and health products. Supply chain players play a key role in a pharmaceutical system so as to ensure the following dimensions are achieved:
Access of medicines – planning and executing the movement on time of medicines from the manufacturer up to last mile
Affordability – managing all related upstream, In-country and downstream related logistics costs such as freight, port Handling , transportation
Quality of medicines – building quality into the product whilst in transit by proactively adhering to GSDP.
Many developing countries face a range of obstacles to achieving this, including rising prices for new medicines; shortages and stock outs. Supply chain players have to ensure the physical integrity and safety of products and their packaging throughout the supply chain especially when in transit until last mile delivery.
Logistics Performance Index
Zimbabwe’s Logistics Context
On the 2023 World Bank Logistics Performance Index Zimbabwe is number 97 out of 139 countries. Zimbabwe has challenges in the following six Logistics parameters as measured by the World Bank:
- The efficiency of customs and border management clearance (“Customs”).
- The quality of trade and transport infrastructure (Infrastructure”).
- The ease of arranging competitively priced shipments (Ease of arranging shipments”).
- The competence and quality of logistics services—trucking, forwarding, and customs brokerage (“Quality of logistics services”).
- The ability to track and trace consignments (“Tracking and tracing”).
- The frequency with which shipments reach consignees within scheduled or expected delivery times (“Timeliness”).
Our logistics is not performing which means supply chain players have to do more in order to deliver health commodities on time when they are needed.
Risks in the Supply Chain
Majority of temperature excursions, mix ups, contamination and introduction of counterfeits occurs when medical products are in TRANSIT in the hands of transporters, shippers, airlines, clearing agents, forwarders and their contractors. Committing a single mistake along the supply chain can destroy the medicines making them worthless and potentially harmful to end recipients.
The risks in the supply chain, which are all threats to public health and safety, vary from:
- Contamination,
- Cross contamination,
- Theft,
- Mix ups,
- Product deterioration,
- Temperature excursions,
- Broken cool chain,
- Falsified medication,
Pharmaceutical Supply Chain Quality Assurance
Medical products help to improve health but only when they are safe, efficacious, and quality assured. Logisticians play a key role in building quality into the product by adhering to Good Storage and Distribution Practices throughout the supply chain of medical products.
Good Storage and Distribution Practices Compliance in the Supply Chain
The process of importing and exporting of medical products will require logistics services such as Customs Clearing, Port Handling, Freight Forwarding, Transportation, Transit storage among other ancillary services. Logistics Services Providers have to demonstrate compliance to applicable GDP requirements. Documented EVIDENCE of GDP compliance has to be available.
Principles of Good Storage and Distribution Practices
Public health considerations demand that medical products should not be treated in the same way as ordinary commodities. Their manufacture and subsequent handling within the distribution chain, both nationally and internationally, must conform to prescribed standards and be rigorously controlled. GDP serves to assure that patients receive quality assured medical products, and prevents the infiltration of substandard and suspected falsified medical products into the supply system.
In transit medical products should be handled and temporarily stored in accordance with Good Distribution Practices (GDP) and Good Storage Practices (GSP) such that:
- The identity of the product is not lost;
- The product does not contaminate and is not contaminated by other products;
- Adequate precautions are taken against spillage, breakage, misappropriation and theft;
- And appropriate environmental conditions are maintained, for example, using cold-chain for thermolabile products.
Application of MCAZ Good Storage and Distribution Practices Guidelines
- Application
GDP guidelines apply to all individuals that deal in the storage and distribution of medicinal products from the manufacturer of medicinal products to the person dispensing or providing medicines directly to the patient. This includes all parties involved in different stages of the supply chain of medical products; manufacturers and wholesalers, as well as brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees.
Good Distribution Practices In Freight Forwarding
Good Distribution Practice (GDP) requires that medicines are consistently stored, transported and handled under suitable conditions, in compliance with product specification as required by Medicines Regulatory Authorities across all countries.
The distribution network for medicinal products is often complex, involving many different parties. In addition to the challenges associated with this complexity, there is also a growing threat from criminal activities seeking to introduce falsified medicines into the legal supply chain. Only through the sound application of GDP by all parties in the supply chain can we ensure that patients receive the quality medicines that they need.
Products require different handling in transit. KNOW YOUR PRODUCTS AND THE PACKAGING TYPE.
Freight Forwarding Of Time And Temperature Sensitive Pharmaceutical Products
Time- And Temperature-Sensitive Pharmaceutical Product (TTSPP) – Any pharmaceutical good or product which, when not stored or transported within predefined environmental conditions and/or within predefined time limits, is degraded to the extent that it no longer performs as originally intended.
Customs Clearing and Port Handling of Medical Products
Customs clearance problems can have far-reaching effects including the risk of penalties if the correct information is not provided upfront. There is also the risk to the product when shipments of certain medications are delayed at the port of entry. Remember there is a patient out there waiting for that product. Many medical products are time and temperature-sensitive, potentially increasing the risk of spoilage if customs clearance is delayed.
Risks at the Port of Entry
Unlike other products that are nonperishable or indestructible, poor handling or inadequate or poor storage conditions at the Port can damage medicines and medical supplies. Medicaments are also highly attractive to thieves. Thus, there is a critical need to clear medical products, as quickly as possible after delivery to any port. The speed of this process is particularly important in landlocked countries, where goods may travel long distances overland, subject to unexpected delays, in less than desirable storage conditions.
Know in advance the product you are handling and its specifications, any storage and handling instructions.
Best Practices – Customs Pre-Clearance
Customs Clearing and Port Handling of Cold Chain
Draw up procedures and memoranda of understanding to ensure that TTSPP shipments are cleared through customs as rapidly as possible. This can be facilitated by a pre-clearance procedure carried out by the local health agency, clearing agent or freight forwarder in collaboration with customs. Alternatively the clearance process should be conducted by customs staff, supported by personnel with suitable pharmaceutical training, especially when clearance involves the opening and resealing of temperature controlled packaging.
Reason: To avoid delays during customs clearance that may cause temperature excursions and place TTSPPs at risk.
CMCOMMS SUPPLY CHAIN QUALITY ASSURANCE
In our desire to promote current GSDP as in other parts of the world, CMCOMMS, through its Supply Chain Quality Assurance Division, is championing this cause. CMCOMMS working closely with Global Health Supply Chain Experts developed a practitioner based training program, which promotes strict adherence to current GSDP guidelines in the supply chain.
About CMCOMMS Medical Logistics Practitioner Training Program.
It is a practical competence based continuous professional development program covering the disciplines of Medical, Logistics and Good practices.
Medical – The goal of a medical/pharmaceutical system is affordable access to safe, effective and quality medicines and health products.
Logistics – Delivering quality and affordable medicines on time is the driving force behind medical logistics.
Practitioner – Handling medical cargo throughout the supply chain in line with Good Practices thereby building quality into the product.
Supply Chain players have to be proactive in exercising due care and diligence in ensuring that the physical integrity and safety of medical products and their packaging is maintained throughout the supply chain especially when in transit until the last mile delivery.
Aim of the training program
- To provide a practical and competence based medical logistics training experience looking at the current constrained logistics context in Zimbabwe
- To introduce and define the practical aspects of Good Storage and Distribution Practices Guidelines (GSDP) applicable to logistics.
Medical Logistics Practitioner Training
A CMCOMMS trained Medical Logistics Practitioner will have the requisite practical skills and expertise:
- Essential to maintain the quality, safety, efficacy and integrity of the medical product throughout the supply chain
- Critical to prevent sanitary issues caused by temperature excursions during transportation.
- In the handling of medical products and compliance with existing regulations and standards.