Featured Pharma Online Editorial

41. How Generative AI Could Change Pharmaceutical Manufacturing 6/14/2024

    Despite the hype, pharma has been slow to integrate artificial intelligence. Other industries have shown how it adds value by simplifying tedious tasks.

42. Defining And Overcoming Batch Release Deviations 5/31/2024

    Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.

43. Sorting Through Winners And Losers Of New Technology In Pharma 5/30/2024

    Innovation and improvement are often used synonymously, but sometimes innovation hinders more than helps. Here’s a cold-eyed look at recent blockbuster tech advances.

44. 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.

45. Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview 5/2/2024

    This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.

46. Integrating Quality Processes And Documentation After A Merger 4/25/2024

    If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.

47. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

    Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

48. Using Relational Risk Analysis To Control Procedure Failures 2/15/2024

    In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

49. Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity 2/8/2024

    It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

50. Need To Improve Your Change Management? Regulators Can Help With That 1/12/2024

    The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.