ARTICLES BY TIM SANDLE

• EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval

  5/5/2025

  In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

• 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025

  12/6/2024

  Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

• Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations

  8/6/2024

  ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

• EMA Updates Guidance On Inhalation And Nasal Product Quality

  5/29/2024

  The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

• Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations

  5/6/2024

  Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

• AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance

  4/8/2024

  The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

• FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance

  1/25/2024

  The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.

• Designing Facility Monitoring Systems For Cleanrooms

  12/4/2023

  Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.

• New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters

  9/11/2023

  The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

• CGMP Requirements For Automated Facility Monitoring Systems

  8/15/2023

  To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.