risk . To be effective , risk management must be a thorough and continuous process , an organisationwide commitment , with responsibility coming from employees in the production suite up to the C-suite . Biopharmaceutical development is complicated and usually lengthier than pharmaceuticals . Risk mitigation demands that the highest quality be maintained throughout the cycles of preclinical , early ( Phase I-II ) and late ( Phase III-IV ) clinical development for product quality and patient safety . Unlike pharmaceuticals , the top risks in biopharma manufacturing are microbial contamination of in-process materials , high bioburden levels , critical component failure and supplier nonconformance . In addition to keeping development and manufacturing costs in line , the goal is safeguarding drug quality and patient safety while at the same time accelerating speed to market . Manufacturers are required to follow ICH Q9 for QRM and ICH Q10 ( 1 , 2 ) for risk oversight by senior quality management . Regulatory assessment has brought about an increased emphasis on the control and management of raw materials . With digital tools now augmenting processes , a digitalised approach can be taken to supply chain design that will increase risk monitoring capability , thereby greatly strengthening safety , resilience and agility . More precise digital tracking and analysis of each raw material or product component will help ensure quality and avoid various supply issues . It is obvious post-COVID that a comprehensive risk management
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Figure 3 - Top considerations for selecting a raw materials supplier
plan includes assessing all potential challenges that can arise from supply chain disruptions , anticipating and planning for inventory levels as potential buffers , boosting agile manufacturing and identifying alternate supply sources .
Quality management
Quality control ( QC ) plays a vital role in commercial innovation and achieving the goal of speeding time-to-market for medicines to be produced and distributed to patients throughout the world . Building a quality-centric company culture is key to significantly improving quality control . For QC efforts to be effective , manufacturers must establish an allinclusive programme that encompasses every core component of their supply chains , including integration , operations , procurement and distribution . The programme should be supported by a qualitycentric company culture led from the top down . Paramount to meeting compliance requirements , regulatory scrutiny and ensuring product safety is to ensure optimal quality and purity of the chemical ingredients , APIs and excipients used in production . In addition , the quality of raw materials and other critical components is only as good as the laboratory tests and scientific documentation supporting that they have been fully tested and traceable . Documentation is imperative and specific products require special testing and certification for bioburden , elemental impurities or endotoxins . Thorough testing reduces process variability and increases repeatability and reproducibility to provide accurate and reliable results . Such documentation , not only on downstream production chemicals but also on materials used during pilot and scale-up phases , mitigates financial and market risk by avoiding down time , and sourcing issues as a product moves through the development process . In conjunction with meeting regulatory demands and best practices , partnering with the right supplier who offers high-quality products and global distribution
36 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981