Contributing Editors

  1. FDA Finds Drug Shortages Are Mostly Caused By Quality Issues 6/6/2022

    New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.

  2. SOPs, The Modern Worker & How Pharma Companies Must Evolve The “Read & Understand” Model 6/1/2022

    Pharma companies have used “read and understand” approaches with standard operating procedures (SOPs) as a core component for staff training for many years. However, what is the percentage of people who are completing their read and understand assignments without truly understanding them? We need to evolve our model of SOPs.

  3. AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs 5/31/2022

    Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.

  4. The Growing Value of Quality & Compliance Professionals in Decentralized Pharma 5/25/2022

    The phrase “the pharma ecosystem” has begun to pop up. Who is best suited to envision, support, and strategize a quality management vision in our current “ecosystem”? Here are some reasons your company and employees should value the unique skillset of these individuals more than ever.

  5. 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    The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market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.

  6. Calculating Process Capability Of Cleaning Processes With Partially Censored Data 5/19/2022

    When cleaning sample results are below the detection limits (DLs) of an analytical method, these data are known as "non-detects" or "left-censored" data. There are basically two broad classes of methods that are applied to left-censored data: Substitution and Estimation. This article explores these methods for use with cleaning sample data when some of the points are below the DL.

  7. Biopharma Partnerships: Key To Filling The Life Sciences Innovation Gap 5/18/2022

    The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

  8. New ICH Q14 Guidance Applies QbD To Analytical Procedures 5/13/2022

    ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

  9. Make This Your New EU IDMP Implementation Strategy 5/9/2022

    Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

  10. Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting 5/3/2022

    The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.