Featured Pharma Online Editorial

  1. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  2. 2024 LIMS Trends 3/15/2024

    The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.

  3. Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety 2/14/2024

    Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.

  4. Is Pre-Compression Tablet Thickness A True Critical Operating Parameter? 2/12/2024

    As recently as Nov. 2023, the topic of how pre-compression tablet thickness is viewed raised its head once again in an FDA inspection at a generic pharmaceutical company in India. This control is available on all modern tablet presses, yet instructions for its use are vague. This article shares how to use this control correctly and to be better prepared for an agency inspection.

  5. FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene 2/6/2024

    Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.

  6. Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma 2/6/2024

    In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.

  7. When In The Product's Life Cycle Does Continuous Manufacturing Make Sense? 2/1/2024

    This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

  8. Driving Pharma/Biotech Capacity With Smart Manufacturing 1/24/2024

    It is time for pharma/biotech manufacturers to consider a new approach to capacity management, one that can not only resolve today’s challenges but also position the enterprise to drive innovation and resilience in the future. You can leverage a smart manufacturing approach in three vital ways.

  9. Are Single-Use Technologies Always The Answer? 1/9/2024

    It is clear that single-use technologies (SUTs) have won the war over reusable stainless steel. However, beneath the surface, there is a web of considerations that challenge the belief that SUTs are unequivocally cost-effective. Let's look at cost considerations as well as risk considerations.

  10. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.