GUEST COLUMNISTS

• Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview

  This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

• Modularity And Mobility Hold The Keys To Surge Manufacturing

  When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

• Create The Correct Checklist To Land The Best CDMO

  When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.

• 1 Year Out, Where Do We Stand On DSCSA Implementation?

  This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.

• FDA Releases Guidance On Drug Products Containing Nanomaterials

  In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

• Frequent Deficiencies In GMP Inspections, Part 1

  It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

• The Upper Nasal Space: Drug Delivery’s Next Frontier

  Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.

• India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022

  To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?