Issue link: https://www.e-digitaleditions.com/i/1462272
www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 35 for a rolling 12-month view provide the supplier with the visibilit y and the agreed conditions to have their manufacturing material released and ready for production when a purchase order is received. Also, robust facil- itation of the impact to DMF [drug master f ile] changes or specif ication changes minimizes quality assurance release concerns relative to the avail- ability of tested and released material for production. Ojinaka (Astrea Bioseparations): Increased delays to raw materials deliv- er y from suppliers meant the Just- in-Time manufacture strateg y was significantly impacted through the pan- demic. Going forward, improved fore- casting aided by data analytics, an open communication link between supplier– organizations–customer, robust S&OP [sales and operations planning] set-up, and a buffer stock strategy will be key to maintaining reliable supply chain. Kirk (Catalent): The pressure on the supply chain and reduced excess capacity has led to day-to-day chal- lenges. To address these, additional scrutiny to the close monitoring and reporting of suppliers' delivery sched- ules should be applied, close relation- ships and communications with key suppliers must be maintained, and c loser inter na l col laborat ion w it h operations teams to adapt to any vari- ation in schedules should be adopted. Giv ing on-time, accurate forecasts helps both suppliers and manufactur- ers; we're all in this together. Lenox (LGM): The pandemic high- lighted the importance of adopting a multi-source strategy and maintaining a geographically diverse supply chain, for clients and their suppliers. By qualify- ing multiple facilities, as well as choos- ing facilities in different geographic regions, a company can help ensure continuity of supply if an unforeseen issue occurs in the country of origin. Further, many organizations have rec- ognized that Just-in-Time planning is not a workable strategy when facing the current multitude of supply chain challenges. Many have adopted dif- ferent approaches, such as increasing safety stocks and adding secondary and tertiary suppliers for all key raw mate- rials and components; others have requested their suppliers start carrying a larger safety stock of their starting materials or intermediates. QUALIFICATION CONSIDERATIONS BioPharm: W hat a re some best practices for qua lif iy ing materia ls received? Lenox (LGM): Access to rea l- time or near-real-time supply-chain data through digitalization can help formulators of branded and generic drugs monitor the qualit y of mate- rials across the entire supply chain and, ultimately, the A PIs they use to produce their f inal drug products. T he b enef it s of a n i nterop er able supply chain are extensive. The pro- cess becomes much more eff icient and fast, and a l lows for rea l-t ime data access. Kirk (Catalent): One of the pri- orit y areas for any company should be to assess where materials are sin- gle-sourced. While it is always best practice not to rely on just one source, the pandemic has high l ighted the ne e d to i mplement more rout i ne dual sourcing and/or alternate prod- uct qua lif ication. W here these are not possible, then inventory manage- ment options are considered. Finally, because of the logistics constraints a nd inc reases in costs, t here is a greater need than ever to consider the geographic locations of suppliers and the impact this has on risk and total cost of ownership. C o l i c c h i o ( D r . R e d d y ' s Laboratories): Best practices for qua lif y ing materia ls includes test- ing of three consecutive lots/batches, vendor certificate of analysis (COA), [and] Full Testing/Reduced Testing/ Minimal Identification testing based on the criticality of the material and supplier history. BioPharm: W hat are some best practices for qua lif y ing companies that provide pharmaceutical materials? Kirk (Catalent): Before qualify- ing a new supplier or when moni- tor i n g e x i s t i n g one s , a r a n g e of considerations covering quality, com- pliance, and risk should be applied. The pandemic has highlighted the reliance that primary or 'global tier 1' suppliers have on their suppliers, a l l t he way back to t he basic raw materials. As a result, it is impera- tive to continually challenge suppli- ers on their own sourcing and the ma na gement of t hei r ow n supply chains. Post pandemic, 'Enterprise Risk Management' overall will be an ongoing need. C o l i c c h i o ( D r . R e d d y ' s Laboratories): Best practices for qua lif y ing companies that prov ide pha r maceut ica l mater ia ls inc lude: [using] questionnaires to understand the quality system; on-site audits to conf irm the qualit y system; qualit y agreements to def ine responsibilities of both parties; and requalification of vendor [to perform] periodic re-eval- uation at defined time intervals based on audit risk rating. Lenox (LGM): The global man- ufact urer ma rket for A PIs is vast, a nd it 's impor ta nt to conduct t he nece s sa r y due d i l ig ence to iden- t i f y h i gh- q u a l it y m a nu f a c t u re r s . Companies routinely should perform qua l it y aud its, a nd a lway s shou ld test incoming raw materials, APIs, etc., to ensure they meet the required specif ications. As part of your dil- igence process, understanding and verifying a manufacturer's regulatory history, overall quality management systems, commitment to transpa r- ency and strong communication, and capacity to support your current and future needs; all are critical to ensure you've selected the right high-quality manufacturing partner. Quality and Regulatory Sourcebook Regulations: Supply Chain