In order for enterprises to be successful, it is of the utmost importance that they comprehend the fundamentals of the GDP standards that were set by the World Health Organization for pharmaceutical products and the European medical agency.

System for the Management of Quality

For the purpose of ensuring that the quality of the supply chain is readily apparent, it is vital for businesses to define quality management system needs and address them with appropriate documentation in the form of procedures, policies, duties, and accountability. When it comes to the success of Good Distribution Practices certification, the analysis of risks is quite important for enterprises that wish to implement GDP criteria. Identifying and resolving the risks is also highly important for the success of the certification.

Leaders Who Are Responsible

During the process of implementing the General Data Protection Regulation (GDPR), an organization must acknowledge the need for leadership. It must also acknowledge the importance of certain individuals within its organization at all levels and assign them specific roles and responsibilities that contribute to the protection of products, the identification of products, the identification and separation of counterfeit medicinal products, and the illegal market for medicinal products.

The responsibility of these leaders inside the companies is not limited to the aforementioned; in addition to this, they are required to combine effective ways that offer quality structure and contribute to the accomplishment of the government’s goals regarding GDP.

The only option for an organization to enhance its leaders’ competency is through GDP training. This training ensures that the leaders comprehend the standard and the requirements of GDP, allowing them to adopt these practices into their day-to-day work life.

The Authorized Suppliers

All wholesale dealers in the medicinal industry are required to make it clear that they only conduct business with approved suppliers who possess the appropriate license and maintain a high level of distribution within their facility. Furthermore, the suppliers must be recognized by an organization or an institute in order to demonstrate that the medicinal products they supply are genuine.

Before engaging in business with a recognized supplier, an organization is required to build a supplier management module that includes an analysis of the supplier to ensure that it satisfies all of the qualitative and legal standards. Additionally, the organization must take into consideration periodic reviews of the supplier’s performance.

Storage Control

Facilities for Storage The storage or warehouse facilities that are connected in the supply chain are required to have high hygiene requirements. These standards must also include temperature regulators and humidity levels, both of which must be continuously evaluated to ensure that they are within acceptable ranges. In order to prevent unauthorized individuals from entering the grounds, there is a restriction on the admission of food and drink inside the building. According to the criteria of the General Data Protection Regulation (GDPR), enterprises are willing to accept the implementation of first in and first out (FIFO) procedures.

Transportation Services and Control

During the process of GDP certification, it is of the utmost importance that the companies possess the appropriate transportation resources. These resources must ensure that the shipping containers or trucks that convey these pharmaceutical items are in compliance with certain regulations while they are being transported.

Labelling

The correct labelling and identification of the containers used for transportation are of the utmost importance, and the determination of the traceability of each individual product is the most significant aspect involved in the transportation process.

Written records

In accordance with the documentational criteria of GDP, an organization is required to put into effect a collection of policies and processes and to maintain pertinent records of execution. Through this documentation, the organizations are required to ensure that they have appropriate records to be able to provide evidence of the complete traceability of a product from beginning to end. The document must be identified specifically for an activity, approval requirements, change management system, and the author and date of the documentation must be clearly specified in the GDP documentation.

Complaints Handling

The organizations need to demonstrate their capacity to handle recalls due to faulty products or falsified medicinal products during the GDP certification process. This is done to ensure that the end user is not impacted by the aforementioned reasons. Additionally, the organizations need to demonstrate their ability to bring the product back from the point where it was delivered without any hassle.

Furthermore, it is imperative that the firms place a strong emphasis on the pleasure of their consumers, with an efficient complaint management system being designed and put into place during the process of GDP certification. When it comes to GDP certification, it is important to address the complaints at the appropriate moment.

Self-Assessment

For an organization to continually improve its established good distribution practice standards, it is extremely important for the organization to conduct regular self-evaluations. This is because the self-evaluations give the organization with an overview of the success that they have achieved while implementing the GDP. In order for organizations to be a part of continuous improvement, it is necessary for each process owner to have a thorough understanding of the internal audit process. Additionally, organizations must frequently evaluate the effectiveness of the GDP controls that have been established inside their organizations.