GCP
Informed Consent Essentials: The 8 Regulatory Elements Your GCP Team Must Get Right (21 CFR Part 50)
Rebecca Beausang
November 30, 2025
Medicinal products are manufactured and distributed in line with rigorous quality and safety standards. By the time pharmaceuticals reach the pharmacy, clinic or patients’ homes, their quality and efficacy need to have been protected along the entire supply chain—from the moment manufacturing is completed until the moment they are administered. This is known as supply chain integrity.
By following Good Distribution Practice (GDP), biopharma companies protect the integrity of their products from degradation and interference while being distributed. These practices play an important role in ensuring that patients are safeguarded against substandard medicines, delays or product shortages and even counterfeit products.
This post will explain which personnel involved in the storage, transportation and handling of medicinal products for human use need GDP training.
GDP is a framework of good practices that relates to the distribution of medicines, and a key subset of GxP standards that guide quality management practices in the life sciences industry. GDP aims to ensure supply chain integrity, meaning that the quality, authenticity and security of the pharmaceuticals are protected, whether through adequate environmental controls such as specified temperature and humidity ranges, or from theft, substitution or contamination.
Regulations that specify GDP standards, including who needs training, vary geographically, depending on the regulator. However, the EU provides the most comprehensive framework for GDP, and many pharmaceutical manufacturers, distributors and wholesalers elect to follow these principles to minimize their risk of falling short.
In the EU, GDP regulations are extensively defined in ten chapters of GDP compliance that fall under the remit of the EMA. Detailed regulations cover quality systems and risk management, outsourcing to qualified suppliers, roles and responsibilities for GDP compliance and the training of personnel.
Distributors and wholesalers will need an EU certification prior to commencing operations, which involves passing an audit and inspection.
In order to pass this inspection, everyone involved in the supply chain will need role-specific training in GDP. This means anyone involved in the storage, transportation or handling of medicines or the coordination or control of these processes.
Training programs must be documented in a Standard Operating Procedure (SOP), and records must be kept showing that role-specific training was delivered prior to the commencement of work. Records must show that personnel demonstrated an appropriate level of competence through an initial competency assessment, with ongoing training and assessments at regular intervals.
Here’s an overview of who needs GDP training:
Although GDP is expected in the United States, and governed by the FDA, it falls under the umbrella of Current Good Manufacturing Practices (cGMP), specifically 21 CFR Parts 210 and 211 that address storage and transport within the context of manufacturing, of finished pharmaceuticals.
Many details remain unspecified in terms of training, and as is typical among pharma companies, this can cause a risk-averse response, with many organizations opting for European-style GDP standards in the face of ambiguity.
Typically, the Qualified Person (QP) who is responsible for following Current Good Manufacturing Practices (cGMP) would require GDP training. Generally, everyone involved in the supply chain in the United States would also receive training in GDP on an ongoing basis to ensure appropriate quality management.
To mitigate their risk, pharma companies often provide annual, GDP training (such as an accredited course in Good Distribution Practice or Pharmaceutical Warehouse and Storage Practices) to their personnel involved in distribution and expect the same from suppliers, such as logistics companies they engage.
Regular GDP training fosters a team culture that values and prioritizes compliance with good distribution practices. Not only can this improve compliance and reduce risk of quality issues, but it encourages team members to proactively identify and address GDP compliance issues and risks before they escalate into larger problems. Additionally, it is crucial to keep senior management fully up to date with GDP and involved in maintaining it. Their awareness of and commitment to good distribution practice are essential aspects of ensuring GDP compliance.
We at GxP Training recommend annual GDP refresher courses for GDP compliance. For example, annual completion of two certified courses from our catalog, which are fully aligned with auditors’ expectations:
Good Distribution Practice: Gain a solid foundation in GDP principles and how they are distributed to maintain optimal quality. This course introduces key concepts of GDP, including supply chain integrity and appropriate transport and storage conditions.
Pharmaceutical Warehouse and Storage Practices: Learn the principles of safe and efficient storage, handling and distribution of pharmaceutical products. This course covers the regulatory requirements governing pharmaceutical warehousing, as detailed in Good Manufacturing Practices (GMP) and GDP and explores best practices for inventory management, order processing and quality control within pharmaceutical warehouses.
All our courses are built to deliver trusted certification, with the following key benefits:
