ARTICLES BY TIM SANDLE
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ChatGPT-4: Practical Applications For The Biopharma Laboratory7/3/2024
AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver?
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EMA Updates Guidance On Inhalation And Nasal Product Quality5/29/2024
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.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations5/6/2024
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.
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Getting Generic Drugs Right: FDA Revises ANDA Guidance2/14/2024
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.
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WHO Guidance Seeks To Reduce Antimicrobials In Pharmaceutical Liquid Waste1/11/2024While 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.
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Designing Facility Monitoring Systems For Cleanrooms12/4/2023
Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.
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Using Automation For Antimicrobial Screening10/5/2023
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.
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New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters9/11/2023
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.
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CGMP Requirements For Automated Facility Monitoring Systems8/15/2023
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.
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FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity7/18/2023
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.