Contributing Editors

41. To Thrive In A Highly Regulated Manufacturing Environment, Improve Your Flexibility 12/19/2023

    It sounds counterintuitive. After all, industry must put (often rigid) rules into place to govern manufacturing processes and ultimately protect the integrity, efficacy, and safety of products. But by adopting process discipline to become more agile, you'll be able to respond to changes more quickly.

42. 4 Strategies To Formulate Poorly Soluble APIs 12/18/2023

    One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. This article examines four notable strategies.

43. 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.

44. Best Practices For Preformulation In Drug Development 12/14/2023

    Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.

45. How Does The GAMP 5 Second Edition Update Look One Year Later? 12/12/2023

    Since ISPE published the GAMP 5 update last year, companies say the flexible approach to computerized system validation is helpful, but the new focus on critical thinking remains a challenge.

46. Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement 12/12/2023

    The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.

47. Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices 12/11/2023

    The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

48. Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow 12/7/2023

    You may have processes in place to prevent drug labeling errors, but they can still occur. Here are three common pitfalls and the eight best practices you should be employing to make sure they don't happen.

49. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

50. 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.