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www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 27 • g reat ly si mpl i f y t he qua l it y compliance processes especially from a shipper's perspective • remove huge amount of dupli- cated effort, overlap, and repeti- tion amongst pharma companies • proactively attenuate some of the risk inherent in the pharma logistics process • introduce greater standardiza- tion of player, process, product, and system including universal technical standards for key sup- ply chain elements • bring pharmaceutical companies together to minimize process divergence, aggregate volumes, share resources, and collectively innovate • re duce t he h igh nu mb er of qua l it y a nd reg u lator y non- conformances • p r o m o t e c o n t i n u o u s G D P improvement a s d ic tated by lega l stat ute, common sense, and moral obligation • provide shippers and logistics ser vice providers (LSPs) with a common reference point for cont i nuou s i mprov ement i n quality and compliance • integrate seamlessly into legacy logistics systems • suppor t and complement the need for greater sustainability when it comes to pharmaceuti- cal logistics • provide a comprehensive GDP training support program • reduce compliance costs as a result of standardization and economies of scale • create a system of shared sup- ply chain audits to streamline risk management, vendor per- formance and GDP compliance (83% of survey respondents [5] are receptive to this) • strengthen physical and digi- tal supply chain security by cre- ating a common platform for GDP interoperability. Program scope and structure Ultimately, the pharmaceutical indus- try has the end-goal of delivering safe and effective therapeutic outcomes for its patients. However, this noble, patient-centric goal involves a com- plex synthesis of numerous quality-re- lated 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 techni- cally valid and robust but, at the same time, f lexible, scalable, affordable, and universa l ly accessible to a lign with myriad supply chain stakehold- ers and accommodate different tacti- cal approaches to GDP compliance. In turn, this will compel a degree of process standardization and unif ica- tion in order to curtail unnecessary compliance permutations and vouch- safe GDP. Figure 3 shows the main building blocks of the MMCS program. As a joined-up and universal risk manage- ment system for logistics, the MMCS w il l comprise multiple operationa l threads all configured and aligned to optimize their combined effect. Some of the more important strands of the program are as follows: Quality and Regulatory Sourcebook Regulations: Supply Chain Figure 2. Some observed obstacles lie in the path of good distribution practice (GDP) reform.