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Understanding Good Distribution Practice: Insights for Beginners in Healthcare Logistics and Manufacturing

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Published - 02.Jul.2024

There are many vital steps in the development of pharmaceuticals and on their path to patients and consumers. There are many important aspects that need to be considered when managing clinical trials and drug testing processes. There is, however, also the important phase of distributing those pharmaceuticals. Starting from the facilities where they are manufactured and ending in the pharmacies where they can be accessed by people who need them. 

 

Good distribution practices (GDP) are a fundamental part of the whole process and are highly valued guidelines not only by regulatory bodies but also by the companies that have to adhere to them. Such guidelines are not only meant to make the transportation of medical products safer but also to make it more efficient. Since the distribution of pharmaceuticals will always be something that is invaluable to society, pursuing a career in the distribution process can be a very beneficial choice. 

 

One of the best ways to start in the vast industry of pharmaceutical product distribution is by acquiring a GDP certificate from an organization like Astra Nova which is accredited by Transcelerate BioPharma Inc. In this article, we explain how exactly you can do that and what possible career paths such a certificate will help you on.

 

What are good distribution practices?

 

To understand good distribution practices we also have to understand good manufacturing practices (GMP). That is because the process of distribution doesn’t only include the transportation of the products but their entire path from raw materials, to the finished product that is received by patients and hospitals. 

 

GMP deals with guidelines that strictly relate to the creation of pharmaceuticals in the facilities themselves. That entire process, however, comes into play in distribution as well. Distribution handles the transportation of raw materials to the manufacturing facilities as well as the products’ distribution to the consumers. 

 

GDP outlines essential principles aimed at ensuring that pharmaceuticals and other medicinal products maintain their quality and safety throughout the entire supply chain. Discrepancies or failures to adhere to key principles are common and frequently result in compromised product quality, thereby posing risks to patients. Being well-educated on the topic is a good quality to have when you’re interested in a career in the industry. You should acquire a GDP certificate to clearly demonstrate that knowledge when pursuing this professional path further!

 

GDP and global regulations

 

Good distribution practices can vary around the world thanks to the laws and regulations in different countries. Despite variations in international guidelines, these documents share similar values and stipulations. Currently, there are over 30 different local GDP guidelines implemented worldwide. There are a couple of different regulatory institutions around the world. 

 

For example, the United States Pharmacopeia (USP) is a nonprofit organization that establishes standards for the quality, purity, strength, and consistency of drugs. While its primary focus is on drug manufacturing, it also impacts GDP by ensuring pharmaceuticals distributed within and imported into the U.S. meet high-quality guidelines.

 

The relevant authority in Europe is the European Medicines Agency (EMA) which is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines. It harmonizes GDP standards across EU member states to ensure consistent pharmaceutical quality and safety.

 

There are such institutions in most countries and a big part of what makes a GDP certificate so efficient is that it is applicable everywhere in the industry.

 

The key principles of GDP

 

As we have mentioned, GDP is directly related to GMP. And when good manufacturing practices are followed, we also have to make sure that good distribution practices are upheld as well. 

 

This way we can maintain the same levels of quality and safety throughout the entire supply chain. Getting a certificate in GDP can teach you exactly what the best ways to handle the process are. Here are, however, just some of the different aspects.

 

Quality Management System (QMS)

 

This system outlines every step of the distribution process. All wholesale distributors must develop their own system where all distribution activities are clearly defined and systematically reviewed. The quality system is the responsibility of the organization’s management, requiring their leadership and active participation, and should be supported by the commitment of the staff.

 

The QMS should be tailored to the organization’s structure and needs. If any activities could compromise product quality, additional review and validation processes should be implemented. The QMS must be thoroughly documented, including the creation of a quality manual.

 

Such a system also allows for the investigation through the documentation. An investigation like this usually includes an analysis of the cause and a thorough risk assessment. When this is fully carried out there are steps that need to be taken according to the corrective and preventive actions (CAPA) process.

 

Personnel

 

To ensure the proper distribution and transfer of drugs or other medicinal products, qualified personnel must carry out the tasks for which the wholesale distributor is responsible. Therefore, in addition to the organization’s management and authority, there should be well-trained and experienced staff who understand their assigned tasks. These responsible personnel should be involved in every stage and phase of the distribution process for medicinal supplies or pharmaceuticals. The number of staff required depends on the scope and size of the assigned tasks.

 

It’s crucial that the responsibilities of individuals in key roles are clearly outlined in written job descriptions. Furthermore, for such individuals, it is essential to completely understand the requirements of GDP and that’s where certification comes into play. 

 

Documentation and operations

 

When learning about GDP, you will learn about another of its fundamental elements – documentation. This step in the process includes:

 

  • all written procedures
  • instructions
  • contracts
  • records
  • data

 

This is usually done in both paper and electronic forms and must be easily accessible. These documents detail operations affecting product quality, such as delivery receipt, storage conditions, and security, and must be approved by an authorized person.

 

Operations focus on following manufacturer instructions and packaging details to maintain product safety and quality. Distributors must implement preventative measures against falsified medicines and ensure proper handling. All medicinal products must have official marketing authorization, with specific requirements for imported products. Adequate documentation ensures traceability throughout the supply chain, from manufacturer to end-user.

 

Product handling and transportation

 

When discussing distribution we cannot fail to mention the process behind handling the products themselves and their transportation. 

 

Product handling procedures must be clearly defined in standard operation procedures (SOPs), covering delivery, receipt, storage, transportation, shipment, and distribution. Pharmaceuticals should be stored separately from other products to maintain quality and safety, protected from inappropriate light, humidity, and temperature. These are only some of the necessary requirements for the safe handling of products.

 

Additionally, the transportation of pharmaceuticals must maintain a couple of uncompromisable factors:

 

  • product identification
  • purity
  • security
  • stability

 

Products requiring controlled conditions must be monitored during transit, with immediate alerts for any deviations. Transportation should adhere to shipment validation guidelines to ensure product safety and quality.

 

Self-inspection

 

We would also like to mention one of the final aspects of education a GDP certificate grants. That is learning about self-inspection programs. They encompass all aspects of GDP, ensuring compliance with relevant regulations and procedures within a specified time frame, and may be divided into smaller audits.

 

Conducted independently by a competent person following approved procedures, these inspections should be thorough and documented in detailed reports, including observations and corrective measures. Quality Assurance (QA) management must periodically perform these audits, document findings, and implement corrective actions based on CAPA methodologies as we have mentioned before. 

 

Now that we have talked about what GDP training offers, let’s see how it’s applicable in the industry and in your chosen career.

 

GDP certification careers

 

There are many different educational backgrounds that companies look for when considering candidates for positions in the distribution process of pharmaceutical products. There are some that are sought out more than others. 

 

Graduates with degrees in Logistics and Supply Chain Management, Pharmacy, and Business Administration can pursue diverse career paths, especially in roles that ensure compliance with good distribution practices. How can these backgrounds be combined with GDP certification?

 

Logistics and Supply Chain Management students are typically well-equipped for roles such as Supply Chain Manager and Warehouse Manager. Their training focuses on managing the flow of goods, which is crucial for maintaining GDP compliance in pharmaceutical distribution. Students can pursue such positions in the industry and a GDP certificate can greatly enhance their credentials and suitability for roles like these. 

 

Another prime example is Pharmacy students, with a PharmD (Doctor of Pharmacy) degree. They often become Quality Assurance Specialists or Regulatory Affairs Specialists. Their expertise in pharmaceutical products and distribution processes is vital for ensuring that these products meet GDP standards, safeguarding their quality and integrity throughout the supply chain.

 

Although Pharmacy students have the right set of skills and knowledge to handle pharmaceutical products, they may not necessarily have the right experience with the specific regulations. That’s where GDP training comes in to assist their knowledge base and provide them with the required expertise. 

 

On another hand, Business Administration students holding a Bachelor’s or Master’s in Business Administration (MBA), particularly those focused on operations and supply chain management, are suited for roles like Supply Chain Manager and Regulatory Compliance Specialist. Their broad understanding of business operations and compliance requirements makes them ideal for ensuring GDP adherence in the pharmaceutical industry.

 

In this particular case, Business Administration graduates may have a better understanding of the managerial side of the distribution process but have a lesser grasp on the medical side of it than Pharmacy students. Medical products require strict safety procedures and strict adherence to protocols and safeguards. GDP training is what can give this type of students the additional education they need.

 

Conclusion

 

There are multitude of roles and positions different companies in the industry can offer. But it’s not about just finding a job. It’s about finding the right role for your particular set of skills and experience. What a GDP certificate can do for you is only enhance that expertise and allow you to pursue a wider range of positions you might already have decided on. Let companies know that your qualifications aren’t only limited to what university you graduated from!

 

 

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