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26 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com est technical and procedural develop- ments. Although there will always be a need for unique and highly special- ist transport arrangements for niche, very sensitive, and potentially danger- ous pharmaceuticals, the vast majority of bulk prescription medicines and vac- cines 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 med- icines, the reality is that there is huge scope for a more standardized and har- monized approach to medicine distri- bution if only the various supply chain stakeholders are prepared to work collec- tively towards a common end. Nevertheless, if such a recognized and widespread need for a more concerted and inclusive approach to GDP com- pliance 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 men- tioned 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). MULTI-MODAL COMPLIANCE AND STANDARDS PROGRAM 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 pro- viding guidance through the growing maze of GDP regulations; one that is global in scope and covers all modes of carriage for bulk pharmaceuticals. T he M MCS prog ra m is a imed at pharmaceutical shippers and the entire distribution chain and is being designed to bring consistency, cer- tainty, and continuous improvement to the complex process of meeting international quality and regulatory standards for the safe, eff icient, and sustainable distribution of medicines, vaccines, and APIs. "The entire pharma-logistics f ield 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, certi- fication, and training in the distribution of vaccines and other medicines. T h e M M C S m o d e l i s b e i n g designed to: Quality and Regulatory Sourcebook Regulations: Supply Chain Figure 1. The perceived benefits of a more integrated approach to good distribution practice (GDP). Figures courtesy of the authors.