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A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
The logistics associated with the safe and efficient physical transportation of pharmaceuticals is increasingly taxing the minds of logisticians as medicines become more complex and labile and their regulatory oversight intensifies. The statutory need to maintain the therapeutic and physical integrity of drugs during transit renders the management of quality and the adherence to good distribution practice (GDP) guidelines an absolutely critical part of the pharmaceutical supply process.
In 2001, the European Union issued Community Code Directive 83 (1) defining a framework for the harmonization of the regulations relating to medicines including the rules governing their distribution. As far as GDP is concerned, this code built on the original EU GDP guidelines of 1994 (2) and has culminated, amongst other things, in the revised EU guidelines of November 2013 for human medicinal products (3) and the guidelines for APIs of March 2015 (4).
However, although the EU guidelines that were introduced in 2013 have formed a template for many subsequent national regulations, even within the EU the exegesis of GDP is open to wide interpretation. To a large extent, this is because GDP is (necessarily) non-prescriptive in nature and the guidance has been enacted in the form of a community directive rather than a regulation. This places responsibility in the hands of ‘National Competent Authorities’ which govern the authorization of wholesale distributors and their compliance with the guidelines.
For now, there is no single global GDP standard despite the harmonization efforts of bodies such as the International Council for Harmonisation (ICH), European Compliance Academy (ECA) and the Pharmaceutical Inspection & Co-operation Scheme (PIC/S). There are literally dozens of national and regional GDP standards in operation around the world. And although most of these are similar and operate under Marketing Authorization Holder (MAH) and Wholesale Dealer Authorization (WDA) type licensing systems, there can be much difference when it comes to detail and enforcement.
GDP guidelines are basically an extension to the GMP regulations which are in force around the world to govern the quality of manufacture of pharmaceuticals and their ingredients. These guidelines cover clinical trials as well as commercial drugs, APIs, and veterinary products. However, despite this common starting point, GMP is fundamentally different from GDP in that the GMP process takes place within a relatively controlled environment whereas GDP processes largely take place at arm’s length, outside the direct control of the manufacturer and involving numerous organizations of varying competence, expertise, and scale.
These supply chain dependencies are both critical and unavoidable, creating a high number of dilemmas and vexations that are endemic to the pharma-logistics process. These include:
Taken together, these factors create a degree of complexity that makes the consistent and reliable execution of GDP across the pharma supply chain a very elusive goal. Indeed, a survey (5)had no less than 40% of pharmaceutical shippers and logisticians citing the reduction of complexity as one of the biggest perceived benefits of greater GDP collaboration and harmonization (see Figure 1).
All this points to the existence of a huge amount of unnecessary replication, regulatory revisionism, compliance ambiguity, and reinventing of wheels when it comes to good distribution practice.
Any system for improving and streamlining GDP compliance is contingent on a comprehensive review of contemporary quality policies and procedures, for example, by questioning the rationale behind each individual pharmaceutical company:
Whether or not it is possible to pragmatically address all the various issues at play in the world of pharma, GDP is down to questioning embedded beliefs and practices as well as having a good understanding of the context in which they have developed. For instance, the notion that each and every medical product and shipping lane requires a dedicated transportation protocol needs to be challenged in the light of the latest technical and procedural developments. Although there will always be a need for unique and highly specialist transport arrangements for niche, very sensitive, and potentially dangerous pharmaceuticals, the vast majority of bulk prescription medicines and vaccines fit into one or two of just a small handful of generally accepted storage environments and temperature bands.
The argument that each and every transportation case is comprehensively different and therefore requires a unique approach is highly conjectural. When it comes to the transportation of medicines, the reality is that there is huge scope for a more standardized and harmonized approach to medicine distribution if only the various supply chain stakeholders are prepared to work collectively towards a common end.
Nevertheless, if such a recognized and widespread need for a more concerted and inclusive approach to GDP compliance exists in practice, it inevitably begs the question as to why the status quo prevails. Perhaps part of the answer can be gleaned from the survey mentioned previously, in which nearly half the respondents cited either personal or corporate inertia as the single biggest barriers to a more ‘joined-up’ approach to GDP (see Figure 2) (5).
It is against this backdrop that the British Standards Institution (BSI) and Poseidon, the independent pharma logistics network, came together in early 2021 to co-develop and execute the Multi-Modal Compliance and Standards (MMCS) program conceived as a consensus-driven foundation for industry-wide GDP standards and providing guidance through the growing maze of GDP regulations; one that is global in scope and covers all modes of carriage for bulk pharmaceuticals.
The MMCS program is aimed at pharmaceutical shippers and the entire distribution chain and is being designed to bring consistency, certainty, and continuous improvement to the complex process of meeting international quality and regulatory standards for the safe, efficient, and sustainable distribution of medicines, vaccines, and APIs.
“The entire pharma-logistics field stands to gain from this collaborative initiative which will improve quality, reduce compliance costs, and promote process and technical harmonization. A more joined-up approach to GDP compliance presents a sustainable way of improving outcomes, reducing costs, and extracting more value from logistics quality in these unprecedented times,” said Angus Metcalfe, BSI Group’s Managing Director, Global Healthcare, when the program was announced (6).
Universal need. With its industry-consensus approach, the MMCS program has been conceived as a universal GDP compliance system that fills the void in the market for a more harmonized and standards-driven approach to quality, qualification, certification, and training in the distribution of vaccines and other medicines.
The MMCS model is being designed to:
Program scope and structure. Ultimately, the pharmaceutical industry has the end-goal of delivering safe and effective therapeutic outcomes for its patients. However, this noble, patient-centric goal involves a complex synthesis of numerous quality-related factors, with adherence to GDP being just one vital part of the overall equation. For this reason, the MMCS program needs to be not only technically valid and robust but, at the same time, flexible, scalable, affordable, and universally accessible to align with myriad supply chain stakeholders and accommodate different tactical approaches to GDP compliance. In turn, this will compel a degree of process standardization and unification in order to curtail unnecessary compliance permutations and vouchsafe GDP.
Figure 3 shows the main building blocks of the MMCS program. As a joined-up and universal risk management system for logistics, the MMCS will comprise multiple operational threads all configured and aligned to optimize their combined effect. Some of the more important strands of the program are as follows:
Industry consultation. Clearly, it is absolutely crucial that the component parts of the MMCS program accurately reflect the needs and priorities of the potential user base and other stakeholders.
For this reason, an official MMCS Consultation Cluster has been established comprising volunteer experts from a broad spectrum of the industry’s stakeholder groups to advise on the program and ensure its neutral, non-partisan status.
Figure 4 shows the current percentage breakdown of the MMCS Consultation Cluster by category. Input is being solicited from both individuals and organizations from right across the industry including responsible persons, established best-practice agencies, quality bodies, and regulatory authorities. The goal is to engage with the industry to improve, consolidate, and standardize the pharma-logistics process without unnecessary duplication, toe-treading, or reinventing of wheels.
The distribution of life-saving and life-enhancing medicines has recently been center stage in the public domain as a result of the continuing COVID-19 crisis. However, the pandemic is not only a tragedy; it is an opportunity and a turning point. With so much at stake and no end in sight, it is time for the industry to come together to find ways of improving and harmonizing how the industry complies with the rules surrounding the safe and efficient distribution of vital medicines.
1. EC, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use.
2. EC, 94/C 63/03 Guidelines on Good Distribution Practice of Medicinal Products for Human Use.
3. EC, 2013/C 343/01 Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use.
4. EC, 2015/C 95/01 Guidelines of 19 March 2015 on principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use.
5. BSI/Poseidon, “BSI/Poseidon MMCS program - GDP Consultation Cluster Survey Report, February 2022: “A review of pharma good distribution practice (GDP) based on industry-wide surveys conducted in November 2021.”
6. BSI, “BSI and Poseidon to Collaborate on Global, Multi-modal Good Distribution Practice (GDP) Compliance Program for Medicines and Vaccines,” Press Release, June 10, 2021
7. E. Krasteva and P. Brown, “Qualifications of suppliers and customers online: reliable or fake news?,” MHRA, Dec. 21, 2020. PT
Courtney Soulsby is sector director, Healthcare & Life Sciences, BSI.
Alan Kennedy is director, Team Poseidon.
Vol. 46, No. 3
When referring to this article, please cite it as C. Soulsby and A. Kennedy, “The State of Phage Therapy,” Pharmaceutical Technology, 46(3) 2022.