Since 2013, GDP, or Good Distribution Practice, has been implemented. It is a certificate confirming the highest standards of transport safety of medical products and substances intended for medical purposes and API substances.

 

DPD’s Good Distribution Practice includes:

 

• maintaining the proper technical and sanitary condition of the infrastructure,
• storage rules for medical products,
• rules and procedures for receiving and releasing medical products,
• conditions for the transport and loading of medical products,
• a properly run pharmaceutical / transport activity
• a method of assigning a replacement to a qualified person responsible for operating a pharmaceutical warehouse / transport company

 

A package of details (described by Pakula Consulting) related to the certificate can be found below.

 

How to get the DPD / GDP certificate?

 

The DPD – GDP certification has been implemented on the basis of EU guidelines from 2013. We have prepared over 100 GDP certifications. So far, we have had 100% success rate. On behalf of our client, we will handle all formal matters with the DPD certification body.

 

The GDP / DPD certificate is issued for 3 years. During this period, the company will undergo two surveillance audits. The DPD / GDP certification covered below comprises:

 

• a review of DPD / GDP documentation,
• a DPD / GDP audit,
• preparing a DPD / GDP audit report,
• issuing a DPD / GDP certificate or a GDP certificate that confirms following the 5th November 2013 guidelines on good distribution practice for medical products.

 

Vehicle and driver documents:

 

The driver is responsible for having the following documents while driving:

 

• the vehicle and semitrailer registration certificate with the valid technical inspection,
• the original copy of the valid vehicle and semitrailer insurance policy;
• a current vignette and, in the case of passing through other countries, a confirmation of payment in accordance with applicable requirements in those countries;
• a driver?s license;
• a qualification certificate or a company certificate of possessed qualifications;
• a certified copy of the transport licence;
• the authorization to use the vehicle (semitrailer) ? optional;
• an ATP document;
• a certificate for sanitary and epidemiological purposes.

 

Loading space and cargo control

 

The loading space must be visually checked before the loading. Check the cleanliness of the vehicle loading surfaces, the tightness of the sheathing and door seals. If any irregularities are found, manage them before weighing the vehicle and loading the goods. The hold must be clean, dry, empty and free of odors from previous shipments.

 

Carrying out hygiene procedures:

• Cleaning,
• Cleaning – made on your own,
• Dry cleaning ? removing dirt.

 

Using brushes and cloths, the cabin should be cleaned on the inside and outside; the body should be cleaned too. Particular attention needs to be paid to all the nooks and crannies of the cabin, rubber components, windows and entrance steps. There must be no previous cargo residue inside the cabin or on its outside.

Remove all moving parts from the cabin: mattresses, wipers, covers, etc. – thoroughly clean the entire cabin, starting from the top, going down gradually. Then clean the wheels, fenders, exterior surfaces and chassis.

Each time before entering the cabin, the driver must thoroughly clean his or her shoes and clothes, so as to remove the smallest residue from transported loads.

The semitrailer must be thoroughly blown with air/ swept from all residue from the unloaded shipment; pay attention to the nooks and places under tarpaulin etc.

 

Requirements for the order of cleaning, washing and disinfection

 

The procedure starts from the dry phase of cleaning; after that, the vehicle is washed, rinsed and disinfected. The cleaning has to be started from the highest places, then gradually move downwards to avoid secondary pollution of the cleaned surfaces. The disinfection can only be effective after using water with cleaning liquid. Disinfectants only work after sludge is removed. The usage of  washing and disinfecting liquids containing active chlorine is allowed only on smooth surfaces that are easy to clean, e.g. stainless steel or aluminum. In all other cases  rinsing, washing and then disinfection is more effective.  Disinfectants must remain on the cleaned surface for at least five minutes in order to be effective. After a certain period of time, the agent should be rinsed off. Basic rules for cleaning, washing and disinfecting should be followed, based on the product categories listed in the standard.

 

The Driver is obliged to verify the quality of the goods loaded onto the semitrailer and provide information to the Freight Forwarder and the Ordering Party. If shipment shows deterioration: molds, fungi or when it is known (laboratory tests from collected samples of the goods have shown) that the goods are microbiologically contaminated, there is a need to declassify the goods and perform appropriate hygiene procedures. The Driver receives information from the transport company?s office about the type of transported goods, specific features and need for appropriate hygienic treatment. If there is no need for cleaning or disinfection and there is no special requirement from the customer, the Driver is obliged to sweep remains from semitrailer after each unloading.

 

Documenting the cleaning and disinfection procedures

 

Each cleaning and / or disinfection must be documented. The principle is that the person performing the cleaning and disinfection enters the fact that the process has been carried out, and the third party describes the effectiveness of the washing and disinfection. Verification is carried out visually. Records of the washing and disinfection and its verification are kept in the Register of washing and disinfection of the vehicle’s body. Each semitrailer has its own register. Washing and disinfection is carried out at the carwash.

 

Loading goods

 

Controlling the loading conditions (weather conditions, safe access, appropriate loading equipment, etc.). If the loading conditions are inappropriate or threaten the safety of the load or vehicle, then the Driver contacts the Freight Forwarder and the Transport Customer and continues to follow the recommendations received from them. Quality control (physical damage, smell, color, humidity, pollution, pests, etc.).

 

If after the organoleptic check the quality of goods raises doubts, the Driver informs Freight Forwarder and Transport Customer.

 

Medical products transport rules

 

Medical products are transported with the use of trucks with isothermal or refrigerated semitrailers. The loading space is adapted for transporting pharma products and its construction helps maintain cleanliness easily or disinfection if required. The floor of the semitrailers is waterproof, made from non-slip material and it is resistant to mechanical damage and corrosion. The semitrailers are equipped with refrigeration units that allow transporting medical products under appropriate sanitary conditions specified by the client and in line with applicable regulations.

 

The basis for accepting a transport order is making sure that it can be effectively implemented in terms of the product?s safety:

 

Standards and transport conditions are set for each order. They specify critical parameters for the sanitary safety of transported products. Critical values for transport conditions have to be agreed with the client in terms of e.g. the sanitary condition of the semitrailer, the refrigeration unit operating conditions, collecting and delivery deadlines, required temperature during carriage, etc.

All arrangements regarding sanitary requirements of carriage must comply with the law regulations and recommendations included in the specifications provided by the manufacturer of the transported goods.

The agreed shipping order transport parameters are verified during and after carriage.

 

The vehicle assessment and checking the product in terms of operational suitability criteria

 

At the beginning of the carriage, the vehicle which will be used for transport has to be assessed in terms of operational suitability criteria and, if required, the agreed product parameters:

 

The loading space of the semitrailer must be adapted to the specific shipments and should enable easy maintenance of cleanliness and order (and disinfection if necessary). The floor of the loading space should be waterproof, made from non-slip material and resistant to mechanical damage and corrosion,

The vehicles should be kept in good technical condition that protects against contamination and enables maintaining the proper quality of products (e.g. presence of foreign odors, large amount of dust, unfavorable humidity, pests, mold). Appropriate corrective and preventive actions have to be taken if necessary.

The devices which are a standard part of the semitrailer?s equipment that are used to maintain the appropriate temperature of transported shipments semitrailer must be efficient and meet the requirements for such devices,

Measuring devices, e.g. thermometers and sensors which the semitrailer is supplied with, should be available and fully functional,

The product prepared for transport should be clean, undamaged, properly secured for carriage and maintain appropriate parameters, e.g. temperature.

 

Carriage and the supervision of transport parameters

 

When transporting products that require low or reduced temperature, the loading space has to be under constant monitoring with the use of measurement devices. The temperature should be adjusted to the specificity of product and arrangements with the Ordering Party. Conditions shall be monitored constantly registered in the form of notes and reports or electronically (data from sensor registered on a storage device).

 

Maintaining sanitary conditions of transport for the safety and quality of the product is offered by:

Maintaining the quality of transported products by keeping a constant temperature in the semitrailer,

Maintaining humidity specific to the product,

Maintaining hygiene in terms of microbiological purity

Protection of the product against mechanical damage and physical and chemical pollution,

Use of adequate precautions during the carriage

Ensuring the efficiency of devices used to maintain the appropriate temperature and the control devices

 

Hygiene rules for drivers

 

Drivers must comply with the place of loading prohibitions and orders, such as:

 

Personal effects such as jewelry, watches, safety pins, etc. should not be worn and brought to the ramp and expedition area,

Glasses must be secured against slipping,

On the company area, smoking is usually prohibited,

Do not spit, chew gum, eat, drink in the expedition rooms,

Cosmetics and personal hygiene products with an intense odor should not be used,

A Driver with minor cuts or scratches on his or her hands should take care of protecting them with a dressing.

Sick drivers may not enter the goods dispatch area.

 

Criteria for individual driver assessment – assessment of the ability to carry out the order:

 

Drivers’ personal protection equipment

 

In order to meet the clients’ requirements in due to protection and hygiene during loading, each driver is obliged to use protective clothing in accordance with the procedures at the loading place.

 

The protective clothing includes:

disposable polypropylene cap

disposable polypropylene apron

foil shoe covers

optional latex gloves

optional hand sanitizer

 

Crisis management

 

Crisis during transport of pharmaceutical products means:

Technical failure of the vehicle,

Vehicle traffic accident,

Product damage occurred during transport.

Refrigeration unit failure,

Failure of temperature sensors,

Theft,

Sabotage – deliberate contamination or damage to the product by a company employee

Terrorism – intentional contamination or damage to the product by a third party, intentional damage of the vehicle or refrigeration unit, intentional breaking of the seals, damage to the door, sensors, etc.

The procedure describes how to respond in case of a breakdown or emergency, e.g. how to secure the load, how to contact the customer and the Driver?s management, how to deal with damage, and other procedures.

 

Procedure during vehicle breakdown

 

If the vehicle breaks down, the Driver should pull off to a parking lot, parking space or side street (road) and:

 

Choose a place that will minimize traffic disruption

Turn on the warning lights

Put on the reflective vest

Set reflective triangle at an appropriate distance and secure against external influences and theft,

Identify the reason of breakdown and check if it can be fixed on your own,

Notify the Owner / Forwarder about the breakdown and the estimated fixing time. If it is not possible to remove the fault yourself, inform the Owner / Forwarder about the alleged causes of the breakdown and which elements of the vehicle require repair or replacement.

Further actions should be performed in accordance with the instructions received from the Owner / Forwarder. After removing the fault, notify the Owner / Forwarder of readiness to continue driving.

If the shipment has to be reloaded from a damaged semitrailer (the thermal insulation, the refrigerator unit or the door is damaged), a second semitrailer should be previously chilled and then placed as close as possible to the semitrailer with the goods. For the time of reloading, both semitrailers have to be connected by the rear with use of thermal foil protecting products against atmospheric factors. The “sleeve” reloading process is monitored – the temperature and humidity in the reloading zone is monitored based on data from the calibrated thermo-hygrometer. It is also recommended that the reloading take place in the shortest possible time (40 minutes or less). To provide objective evidence of the compliance of the reloading, the process is recorded. After reloading the product into a functioning semitrailer, the loading space is sealed and the transport process continued.

 

During downtime caused by a failure, the Driver is responsible for securing the load against possible damage. In case of calling the police, he or she is responsible for collecting relevant documentation regarding the incident.

 

The driver informs the Forwarder about damage done to the transported goods and specifies its degree on a regular basis. 

The driver is obliged to inform the Forwarder about the condition of the seals.

The driver is obliged to assess the impact of the accident / failure on the operation of the refrigeration unit and the microclimate in the semitrailer. The frequency of temperature and humidity readings should be increased.

If the shipment has been partially damaged and returned from consignee, the Driver is responsible for delivering to the company the necessary documentation confirming the incident in order to make corrections in the sales documents.

 

Procedure in case of the vehicle?s accident

 

If the Driver was not injured in an accident, he or she is obliged to inform the police by calling 997 or 112. If people are injured in the accident, the Driver should first help them and call emergency services.

 

After fulfilling these duties, the Driver is obliged to check the condition of the vehicle and transported shipment. The Driver should then establish his or her approximate location on the road inform the Owner / Forwarder of the situation.

 

If it is necessary to notify the insurance company, the Driver should contact the Owner / Forwarder.

If possible, the transported goods need to be secured against damage or loss.

 

After the arrival of the police and drawing up an accident report, the Driver requests a copy of it. This document is necessary to receive compensation from the insurance company.

 

After completing all formalities, but when truck cannot continue the route, driver should not move away from the accident place and should wait for help from his or her company.

 

If the insurance company does not require a local inspection at the accident place, after arrival of assistance and depending on the condition of the vehicle:

 

If the vehicle involved in the accident meets all the requirements for participation in the road traffic, the goods on the vehicle must be protected against damage and scattering, or the goods should have been reloaded to a second vehicle,

 

It is not allowed to collect goods that have spilled from the vehicle to the ground, because such goods may cause contamination of the remaining batch on the vehicle. The Driver should continue trip to the point advised by the Owner / Forwarder.

The driver who was involved in the accident should be replaced by another driver.

 

After arrival at the unloading place, the person receiving the shipment should be notified of the situation and after unloading there should be prepared  a Crisis Report. Copy of this document is given to the Driver.