One Year Later: Good Distribution Practices Program
Chuck Forsaith, Vice President of HDA’s Pharmaceutical Cargo Security Coalition, and Henry Moran, Director of ASC Associates, have collaborated and worked within the U.S. pharmaceutical transportation industry for over 20 years. In 2024, they launched the PCSC’s Good Distribution Practices (GDP) program after identifying a distinct gap in the industry — the lack of GDP standards for transporting medicines.
GDP refers to a set of guidelines that ensure the quality and integrity of medical products as they are distributed within the pharmaceutical supply chain. The basis for the PCSC’s GDP program comes from the only universally recognized GDP standards in the world, that of the European Medicines Agency, based on HPRA and PIC/S guidelines.
While both manufacturers and distributors can partake in the program’s benefits, there is a concerted effort to involve businesses that support the pharmaceutical industry, including transportation, freight-forwarding, freight brokerage, warehousing, 3PL and insurance entities. This effort is seen as one to educate those entities about the importance of product integrity within the pharmaceutical supply chain and patient safety. During its inaugural year, DeSpir Logistics became the first company to be fully accredited through the program’s rigorous assessment process.
At HDA’s annual PCSC Education Seminar this spring, Forsaith and Moran announced that the one-year-old GDP program had accredited an additional six companies: KL Harring Transportation, Baylor Trucking, Tucker Company Worldwide, Prime Inc. and AGY Logistics. Several companies are expected to receive their certificates in the coming months. Below are some program highlights Forsaith and Moran shared during this year’s PCSC Seminar.
Pillars and Benefits of the Program
According to Forsaith, it was important to establish a set of guiding pillars for the program. Alongside Moran, they came up with the following three key pillars:
- Developing pharmaceutical and life science handling standards;
- Training stakeholders on those standards and regulations; and,
- Assessing operations by conducting an audit and gap analysis.
Companies participating in and completing the program receive commercial benefits that differentiate them in a crowded market. “We have seen successful participants acquire new and strengthened business relationships through demonstrating their excellence. Pharmaceutical and insurance companies can now use the program as a benchmark for quality and risk reduction,” said Moran. “They can also demonstrate compliance with international regulations and standards.”
The program also assists companies looking to minimize waste and mitigate inefficiencies in storage and transportation. Furthermore, adhering to these criteria can prevent compliance and quality disruptions, thereby maintaining product integrity and safety.
Certification Requirements
There are three phases to the required training for a business entity to obtain accreditation after applying to the program.
- GDP Introductory Training (One hour, conducted virtually);
- GDP Awareness Training (Six hours, conducted virtually over a one- or two-day period); and,
- GDP Responsible Person Training (Twelve hours, conducted in person over two days).
A minimum of two individuals from each business entity must be trained in all three phases of the program. It is recommended that more than two individuals receive GDP Introductory Training.
Introductory and Awareness Training are conducted virtually, whereas Responsible Person Training takes place in person over two days in groups due to its intensity level. Responsible Person Training is offered quarterly at a site selected by HDA.
Lessons Learned
Moran reflected on lessons learned from the program’s first year. “Every participant has been open to new ideas and ways of working,” said Moran. “The accreditation program is very much undertaken at the participant's pace, making it easily accessible for busy employees.”
It has also become understood that, although not yet mandated by the regulator, GDP accreditation has become a key requirement for Requests for Quotation. The areas Moran and Forsaith have identified as needing the most significant room for improvement include the structure of the Quality Management System and increasing awareness of falsified and counterfeit medicines.
Looking Ahead
“The response to the GDP Program has been astounding,” said Forsaith. “The dedication of … employees throughout the assessment process [exemplifies] this industry’s commitment to supply chain safety and security.”
“We anticipate several other companies will be eligible for accreditation this year,” said Moran. The program is incredibly robust and can take employees several months to complete. There are currently numerous program participants, and following the PCSC Seminar, more companies have expressed interest in joining the program.
If you are interested in the GDP program, visit https://www.hda.org/pcsc/gdp-accreditation-program/ or contact Chuck Forsaith.