Expert Insights On Cold Chain

  1. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

    The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

  2. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

    Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

  3. FDA's Final Rule On Intended Use For Drugs & Devices 9/10/2021

    On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. It provides clarity to manufacturers, but many remain dissatisfied with the evidentiary standard for determining intended use. Might legal challenges follow?

  4. How To Find & Manage Biotech Consultants Effectively 9/6/2021

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

  5. What's The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

  6. Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance 8/27/2021

    Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.

  7. Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins 8/25/2021

    Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.

  8. How Does A Mature QMS = Fewer Drug Supply Chain Disruptions? 8/16/2021

    The FDA’s Office of Quality Surveillance launched a voluntary program to evaluate manufacturers’ quality management systems to inform decisions on the future development of an FDA rating system characterized as quality management maturity. This article explains the importance of QMM and what that looks like to the FDA.

  9. Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances 7/5/2021

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

  10. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

    Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.