SUPPLY CHAIN MANAGEMENT
Unfortunately , ideal worlds do not really exist in supply chains when supporting these activities .
Procurement teams regularly encounter problems with later-phase API projects where significant work has been performed and little due diligence considered for the CRM supply sources . Approaching laterphase activities , like engineering and registration batches , as a precursor to prospective process validation , we can uncover issues where the sources inherited are not suitable for long-term qualified supply and in certain cases cannot even be identified .
This does not create any insurmountable challenges for procurement , but it can impact the technical aspects of the project and the later the change , the bigger the impact . Not only will the chemistry require review , there could be an effect on any validated analytical methods for raw materials , the corresponding intermediate and API specifications .
Amendments at this stage can be expensive and any significant revalidation activities will take a considerable amount of time . These activities are avoidable if earlier-phase
CRM selections have been considered in greater detail .
When considering manufacturing sources for these materials , the evaluation process within procurement considers both the fundamental aspects and the more formal regulatory obligations . Figure 3 highlights the perspectives of each .
Other factors will be studied as the project develops , and during each qualification the activities may vary slightly but by ensuring the above attributes are in place before qualification , the best probability of generating long term validated CRM supplies can be provided .
Issues with smallscale CRM supply
A crucial challenge of focus is when there is a need to fully qualify tiny amounts of basic reagents and commodity chemicals that are deemed as CRMs in a commercial orphan API project . Many of the global large-scale producers of these materials are not interested in completing questionnaires or hosting audits to allow the required processes to ensue .
Sourcing these materials from trusted producers is not an option as they are not synthetically complex enough to produce and the amount required is not commercially sustainable ; therefore , less robust sources may be approached for qualification with a larger emphasis on supply chain management for ongoing supply .
Almac is creating options to improve its position regarding these challenges , and it would be beneficial for regulators or government bodies getting involved to facilitate these requirements . The generation of a facility self-assessment questionnaire and audit pack in lieu of supporting the onsite activities may even suffice . There is no doubt that supply chains will continue to develop as APIs become more sophisticated and the need for controlled manufacture of CRM is essential . There may be a cornucopia of manufacturers globally , but the selection criteria must be scrutinised to ensure security of supply and the right partner is selected . Almac has developed supply chain strategies that align with the phase of development and to minimise risk .
Challenges and risks for delivery of supply chains have been amplified during the last five years due to a myriad of reasons , including COVID-19 , environmental changes and the war in Ukraine , etc . Companies have had to evolve and develop while keeping up with the pace of significant and consistent business growth .
For Almac , the supply of CRMs is a priority with back integration of CRM manufacture part of our current offering . We will continue to develop our processes in line with customer needs and build the associated technologies to support . ●
Almac Group
k + 44 28 3839 5815 J media @ almacgroup . com j almacgroup . com
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