• Getting Generic Drugs Right: FDA Revises ANDA Guidance

    To improve the quality of abbreviated new drug applications (ANDAs) and to ensure improved consistency, the FDA has developed a new guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval. This new guidance replaces the previous September 2020 version.

  • FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance

    The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance.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.

  • WHO Guidance Seeks To Reduce Antimicrobials In Pharmaceutical Liquid Waste
    While most nations have regulations and emission standards regarding industrial waste containing antimicrobials, there is no globally accepted framework. This new WHO guidance seeks to establish an independent, scientifically derived framework for applying targets to manage discharges from antibiotic manufacturing facilities. The public comment period ends Jan. 26, 2024.
  • Designing Facility Monitoring Systems For Cleanrooms

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

  • Using Automation For Antimicrobial Screening

    A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.

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

    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

    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.

  • FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity

    The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

  • Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

    The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

  • FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors

    An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.


Tim Sandle

Tim Sandle, Ph.D., is a pharmaceutical professional with wide experience in microbiology and quality assurance. He is the author of over 30 books relating to pharmaceuticals, healthcare, and life sciences, as well as over 170 peer-reviewed papers and some 500 technical articles. Sandle has presented at over 200 events and he currently works at Bio Products Laboratory Ltd. (BPL), and he is a visiting professor at the University of Manchester and University College London, as well as a consultant to the pharmaceutical industry. Visit his microbiology website at