The global pandemic is impacting supply chains worldwide, but pharmaceutical supply chains are especially vulnerable. Manufacturers are under pressure to help maintain the supply of critical medicines during COVID-19 as well as contribute to the on-going efforts to support the ever-changing supply chain.
As pharmaceutical manufacturers reprioritize production due to changing and increased product demand, many don’t have alternate suppliers for critical components. This has been a game-changer as they not only have to identify new suppliers, but they must also qualify these components to ensure they understand impact on process, and that quality meets the required standards.
Manufacturing partners across geographic regions are navigating this “new normal” under stressful conditions exacerbated by increased demand for APIs, new supply chain challenges, and an ever-increasing global focus on maintaining quality. To truly succeed as an industry, we must knowledge share and problem-solve together to advance and proactively prepare for the continued success of our mission as an industry.
As Co-Chairs of the 2020 ISPE Asia Pacific Pharma Manufacturing Virtual Conference & Executive Forum, we invite you to join us for this collaborative forum where you can learn and ask questions on key trends, best practices, and regulatory perspectives for maintaining pharma supply chain reliance, overall quality, and compliance sustainability.
Nowhere else can you participate in actionable, interactive discussions featuring case studies and dedicated Q&A time with experts representing FDA, MHRA, local health authorities, Pfizer, Biocon, and more as they answer questions like:
You can submit your questions on the event homepage prior to the conference or ask your questions in real-time. Stay knowledgeable throughout the year with on demand access to all session recordings and presentations for one year.
Collaboration is a crucial element in mitigating the impact of COVID-19 on the pharmaceutical supply chain. We encourage you to register today to ensure you have the strategies to make your operations more agile, compliant, and resilient to disruption.
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...