ISPE Considerations for Pharmaceutical Supply Chains related to the COVID-19 Pandemic
In response to the COVID-19 pandemic, several governments are considering legislation or regulatory actions that would require some or all parts of a drug product’s supply chain, e.g., Active Pharmaceutical Ingredients (APIs) and biotherapeutic drug substances, to be manufactured within their countries to ensure consistent availability to patients and reduce potential drug shortages. The International Society for Pharmaceutical Engineering (ISPE) is uniquely positioned to support discussions with appropriate government or regulatory agencies on the technical and regulatory challenges related to relocating the site of manufacture or introducing new technology to increase assurance of supply of medicines. As a leading not-for-profit professional society dedicated to scientific, technical, and regulatory advancement of pharmaceuticals, ISPE has been instrumental for more than a decade in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities. Examples of ISPE programs supporting improvement of pharmaceutical manufacturing supply chains are the ISPE Drug Shortages and Continuous Manufacturing programs.
Pharmaceutical companies are deliberate in their responsibility to establish and manage their supply chains and to ensure appropriate quality and supply of Active Pharmaceutical Ingredients and medicinal products for patients worldwide. It is not uncommon for chemical Active Pharmaceutical Ingredient supply chains to include multiple/redundant suppliers, multiple global sources for raw materials (solvents, reagents, catalysts, intermediates, starting materials, etc.) and product components, ranging from commodity bulk chemicals to special custom materials. Some components and raw materials used in pharmaceutical products may have limited suppliers worldwide. Therefore, to successfully leverage a specific geographic location(s) for manufacturing may have significant challenges. A well-established supply chain for commodity, bulk, and specialty chemicals is not easily transferred to a local manufacturing site. Without careful planning and consideration, such changes could significantly disrupt and stratify the supply chain and reduce availability of critical and essential medicines.
In addition to a change in the manufacturing site, raw material changes or the introduction of new technologies can lead to significant technical and regulatory challenges. Such changes may require laboratory or pilot scale studies to redevelop or adjust the process or develop a new route of manufacture, requiring significant scientific resource and time to ensure product comparability between the legacy and newly established manufacturing process or operation(s). Regulatory requirements that differ between countries and regions globally lead to differences in the timelines for approval(s).
The ISPE Drug Shortages program has initiatives underway to develop new resources for successful Business Continuity Planning and Health Authority engagement, both of which offer powerful opportunities to mitigate or prevent drug shortages. Business Continuity Planning is a program targeted at industry leaders to assist them developing business processes for applying risk management exercises to the manufacturing supply chain. Strategic application of all dimensions of the already available ISPE Drug Shortages Prevention Plan and Drug Shortage Assessment and Prevention Tool could be used to support risk assessments and identify vulnerabilities in currently licensed or newly established supply chains.
The application of continuous manufacturing technologies can support improved supply chain efficiencies and ISPE has been in the forefront of supporting its introduction from a technical and regulatory perspective in workshops, conferences, and the publication of articles.
ISPE supports advancement of science, global cooperation, and regulatory harmonization and alignment to improve access to medicines to patients worldwide. ISPE has a very active Drug Shortages program, strong expertise in advanced manufacturing technologies for small and large (biopharmaceutical) molecules, technology transfer, and supply chain robustness. Relocating Active Pharmaceutical Ingredient or drug product manufacturing or its components requires careful evaluation to prevent unintended consequences that may increase supply risk. ISPE’s subject matter expertise, knowledge networks, publications, and guidance documents can assist in the evaluation of technical, regulatory, and workforce challenges associated with establishing new or relocating site(s) of manufacture and minimizing supply chain reliability risks.
ISPE is prepared to provide platform(s) for discussion with appropriate government or regulatory agencies for recommendations and collaboration on technical and regulatory matters to improve reliability of supply.
Thomas Hartman, on behalf of ISPE
President and CEO