GCP
Informed Consent Essentials: The 8 Regulatory Elements Your GCP Team Must Get Right (21 CFR Part 50)
Rebecca Beausang
November 30, 2025
When pharmaceutical products reach patients, their quality, safety and efficacy needs to have been maintained throughout the supply chain—from the moment they leave the manufacturer, to when they arrive at the point of administration.
Good Distribution Practice (GDP) is a fundamental part of ensuring this happens, and safeguards patients from risks such as poor product quality, delays and even product counterfeiting. This post will explain how distribution personnel in pharma need to be trained on an ongoing basis so that pharma organizations can meet their obligations through accredited GDP training.
GDP is an international framework of guidelines for the proper storage, handling and transportation of pharmaceuticals that ensures they remain in optimal condition. The framework has been integrated into the regulations that govern many local markets/regions, such as the United States or the European Union. However, as with most such cases, the exact details vary from one regulatory body to the next. For example, GDP requirements in the United States are governed by the FDA and outlined in Current Good Manufacturing Practices (cGMP), which refers to the storage and transport of finished pharmaceuticals to maintain quality, whereas in the EU, GDP regulations are defined in separate legal documents under the remit of the EMA.
Importantly, when pharma companies distribute their products within a market, GDP standards must be complied with. This includes ensuring that all personnel within the supply chain are trained and comply with GDP expectations.
Everyone involved in the storage, transportation and handling of medicinal products for human use needs role-specific GDP training before they start their duties, and on an ongoing basis, to ensure that the correct procedures are complied with.
EMA GDP regulations are more comprehensive than those of the FDA. They specify that:
“All personnel should be aware of the principles of GDP that affect them and should receive initial and continuing training relevant to their responsibilities.”
EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use
A comprehensive training program must be documented in a Standard Operating Procedure (SOP), so that the training process can be effectively managed. Training records must be kept showing both initial and ongoing structured training that is relevant to specific personnel roles and responsibilities, as mandated by the local regulatory body. This documentation should include initial competency assessments that demonstrate appropriate competence and experience prior to starting work, with ongoing assessments at regular intervals.
In addition, training should include aspects of product identification to avoid falsified medicines entering the supply chain and personnel dealing with medicinal products that require more stringent handling, such as hazardous products, radioactive materials or products that present a special risks of abuse (like narcotics or psychotropic substances), or temperature-sensitive products, should be given specific training.
After having received initial training before commencing their duties, ongoing training is crucial to maintain competence and keep personnel updated on any changes to regulations or best practices. However, the FDA and EMA don’t specify how often GDP training should be completed by personnel. Typically, most pharma companies prefer to adopt a risk-minimization strategy.
A risk-based approach to training means that personnel involved in high-risk activities or roles receive more frequent training. The frequency of continuing professional training in GDP is typically determined by a pharma organization’s risk assessment and training function, with guidance from the compliance and legal functions.
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.
The effectiveness of the training program should be periodically assessed and documented, to ensure that personnel (both inhouse and those of external suppliers) understand and are able to meet their responsibilities.
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:
