Featured Pharma Online Editorial

41. Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses 10/18/2023

    Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.

42. Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations 10/12/2023

    Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.

43. Is 'Human Error' The Cause Or The Outcome Of GMP Deviations? 10/6/2023

    Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.

44. FDA Introduces Quality Management Maturity Program 9/26/2023

    The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.

45. Risk Tool Selection With ICH Q9(R1) In Mind 9/19/2023

    This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

46. 6 Ways To Achieve Manufacturing Audit And Inspection Readiness 7/19/2023

    Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.

47. Avoid These 29 API Manufacturing Deficiencies 7/17/2023

    Most API manufacturers are constantly improving their processes, but mistakes still happen. This list of deficiencies from the GMP Compliance Adviser explains what to watch out for.

48. Combination Product QMS Requirements For The EU Market 6/30/2023

    Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

49. ICH Q12 Post-Approval Change Management Protocol 6/27/2023

    The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.

50. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically.