Featured Pharma Online Editorial
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
3/7/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
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Strategic Procurement For Emerging Pharmas & Biotechs
2/27/2023
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.
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What Is Contributing To The API Shortage?
2/8/2023
No, you can’t have your cake and eat it, too. In this case, your “cake” is a 6-cents-worth generic pill. We have seen a precarious competitive situation with generic drug manufacturing for several years now; what are the key trends and their impacts on the pharma supply chain? Let's investigate.
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1 Year Out, Where Do We Stand On DSCSA Implementation?
11/21/2022
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
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Autonomous Supply Chain Planning Is Within Reach
10/19/2022
In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
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The Process Map To Ensure Biopharma Raw Materials Supply
8/16/2022
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
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FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance
5/24/2022
The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.
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Merck's 2 Lessons Learned: Overcoming Single-Use Supply Challenges
1/12/2022
The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.
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EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance
12/28/2021
With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.