Issue link: https://www.e-digitaleditions.com/i/1462155
50 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Supply Chain ferent geographic regions, a company can help ensure continuity of supply if an unforeseen issue occurs in the country of origin. Further, many organizations have recognized that Just-in-Time planning is not a workable strategy when facing the current multitude of supply chain challenges. Many have adopted different approaches, such as increasing safety stocks and adding secondary and tertiary suppliers for all key raw materials and components; others have requested their suppliers start carrying a larger safety stock of their starting materials or intermediates. Qualification considerations PharmTech: What are some best practices for quali- fiying materials received? Lenox (LGM): Access to real-time or near-real-time supply-chain data through digitalization can help formulators of branded and generic drugs monitor the quality of materials across the entire supply chain and, ultimately, the APIs they use to produce their final drug products. The benefits of an in- teroperable supply chain are extensive. The process becomes much more efficient and fast, and allows for real-time data access. Kirk (Catalent): One of the priority areas for any company should be to assess where materials are single-sourced. While it is always best practice not to rely on just one source, the pandemic has high- lighted the need to implement more routine dual sourcing and/or alternate product qualification. Where these are not possible, then inventory man- agement options are considered. Finally, because of the logistics constraints and increases in costs, there 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. Colicchio (Dr. Reddy's Laboratories): Best practices for qualifying materials includes testing of three con- secutive lots/batches, vendor certificate of analysis (COA), [and] Full Testing/Reduced Testing/Mini- mal Identification testing based on the criticality of the material and supplier history. PharmTech: What are some best practices for qualifying companies that provide pharmaceuti- cal materials? Kirk (Catalent): Before qualifying a new supplier or when monitoring existing ones, a range of con- siderations covering quality, compliance, and risk should be applied. The pandemic has highlighted the reliance that primary or 'global tier 1' suppli- ers have on their suppliers, all the way back to the basic raw materials. As a result, it is imperative to continually challenge suppliers on their own sourcing and the management of their own supply chains. Post pandemic, 'Enterprise Risk Manage- ment' overall will be an ongoing need. Colicchio (Dr. Reddy's Laboratories): Best practices for qualifying companies that provide pharmaceutical materials include: [using] questionnaires to under- stand the quality system; on-site audits to confirm the quality system; quality agreements to define responsibilities of both parties; and requalification of vendor [to perform] periodic re-evaluation at defined time intervals based on audit risk rating. Lenox (LGM): The global manufacturer market for APIs is vast, and it's important to conduct the necessary due diligence to identify high-quality manufacturers. Companies routinely should per- form quality audits, and always should test in- coming raw materials, APIs, etc., to ensure they meet the required specifications. As part of your diligence process, understanding and verifying a manufacturer's regulatory history, overall quality