The Scope of the GDP
GDP transport guidelines have a far wider-reaching scope than many would like to agree. ELPRO acknowledges that collaboration between all pharmaceutical chain stakeholders can help make the regulations more effective to support medicine and vaccine safety efforts.
The product manufacturer and distributor are typically two separate entities, and both need to show cold chain compliance. Otherwise, there will be a breach when moving the goods from the production line into the distribution line. Through that breach, counterfeits may come in, or laxity in product handling could cause discrepancies in product integrity.
Training for Distribution Personnel
For a seamless GDP transportation system, there is a need for adequate personnel. ELPRO recommends trained and qualified personnel as a critical component for good pharmaceutical distribution.
Cold chain compliance will not be effective if the human resources do not have sufficient training. Additionally, the training cannot avail much if personnel are not well equipped for transportation duties. Therefore, there first needs to be a comprehensive training system to raise awareness for the GDP requirements. The training program's other goal should be to address the relevant standard operating procedures when handling pharmaceutical products.
For products classified as hazardous, like radioactive substances and narcotics, specialized training is necessary to equip responsible personnel with skills to handle the goods safely.
Reports show there is a dramatic spike in the number of counterfeit drugs that are entering the market. One way of combating this is to use training to help personnel differentiate genuine products from counterfeits.
GDP transportation systems can benefit immensely if the training is continual with regular assessments. This way, the personnel can acquire current techniques, guidelines, and protocols while building upon existing knowledge.
Quality Management System
For successful cold chain compliance, there needs to be a quality management system (QMS). It is recommended that each organization draft a quality assurance policy that aligns with the GDP guidelines.
A vital component of the policy document is a formally expressed quality requirement list that will form the foundation for succeeding quality control checks. Before any pharmaceutical product joins the distribution chain, the quality standards must be clear.
Next, the relevant transportation company must work to maintain those standards until the product reaches the consumer. With such a system in place, one can use ELPRO services and products to ensure continuous compliance and optimum product quality throughout the transit period.
Besides an elaborate policy document, the quality management system cannot work without a proper organizational structure. The personnel involved and their roles and tasks should be established.
Additionally, there must be adequate resources to support the quality management system, whether in terms of finances, human resources, or administrative support. The quality management team's work ensures products in transit are in the right kind of environment. They also perform assurance checks to confirm that the products at the end of the chain are safe for human use or consumption.
In-Transit Storage Guidelines
GDP transport guidelines acknowledge that during transportation, there may be a need for temporary storage. Although there are broad storage guidelines in the GSP manual, the GDP offers an additional set of standards. An essential consideration for pharmaceutical storage facilities is the ability to monitor and control environmental conditions.
ELPRO acknowledges this need and provides expert validation and mapping services. Temperature mapping will help establish hot and cold zones in the storage facilities that offer optimal sensor placement. Mapping can also identify areas that need remedial work. Changes to the structure or rearranging shelving, for example, can ensure a uniform temperature across the entire storage warehouse.
Validation and Qualification for Compliance
Validation is necessary to confirm that in-transit storage chambers produce the expected results. GxP rules require that all processes undergo validation, including facilities that intend to adhere to cold chain compliance standards.
On the other hand, qualification looks at proving that a system, transportation container, or organization satisfies a particular purpose.
Transportation of pharmaceuticals requires special tools, temperature monitoring technology, and facilities. The vehicles need extra protective features to shelter products from temperature fluctuations and other weather elements.
ELPRO monitoring systems are ideal to monitor the temperature and other parameters in transportation containers, from the product's collection point to the destination.
With continuous feedback from such systems, one can conduct validation and qualification procedures effectively. Without adherence to GDP transport guidelines, it is like walking in pitch darkness; there is nothing to show cold chain compliance for transportation chambers, storage facilities, and equipment.
It is crucial to qualify all elements before validation can begin. Some essential pharmaceutical distribution chain components that need qualification and validation are storage chambers, insulated boxes, data loggers, and cold rooms.
Once these components undergo qualification as stipulated in the EU-GMP Guideline Annex 15, then validation can begin. It is impossible to have GDP compliance without validation and qualification programs in place.
The GDP transport guide for cold chain compliance provides a means to overcome product insecurity during transportation. However, there must be collaboration between all stakeholders in the entire pharmaceutical supply chain for the guidelines to be effective.
Besides ensuring product safety, these guidelines offer benefits like quality maintenance, blocking loopholes for the emergence of counterfeit products, and ensuring consumer safety.