Articles in this Issue

• Establishing and Managing the Drug Product Stability Budget

  Erik J. van Asselt, PhD, Rafik H. Bishara, Ph.D.
  How long can a pharmaceutical product be exposed to temperatures outside the recommended storage conditions? How can product discard be prevented in cases of temperature excursions? How to establish and to manage the allowed time out of storage of a pharmaceutical product? The short answer is: It all depends on the chemical and physical properties of the product, the knowledge about product stability and the presence of temperature exposure data. In this article, the science behind the establishment of a stability budget for products that need to be maintained under controlled temperature conditions will be explored and guidance will be provided to manage the product stability budget in the (bio) pharmaceutical supply chain.

• The Unintended Inefficiencies of Outsourcing Practice

  Kenneth Getz, Mary Jo Lamberti
  Historically, the decision to hire contract service providers was driven in large part by the need to employ variable capacity and to gain access to scientific and geographic expertise.

• Cleaning Residue Distribution: Uniform or Non-Uniform?

  George F. Klein
  Many readers are familiar with the widely used method of Fourman and Mullen in setting cleaning validation/verification limits for pharmaceutical manufacturing facilities. Implicit but key to use of the method is the assumption that residues are uniformly distributed on processing equipment.

• FDA Delays Critical Decision on Generic Drug Labeling and Scope of Potential Tort Liability...

  Evan M. Lazerowitz, John C. Maloney
  The current regulations of the Food and Drug Administration (FDA) impose different requirements upon brand-name and generic drug manufacturers when it comes to changes in labeling to reflect newly discovered adverse effects and other drug safety information.

• CMOs and GDUFA: Shaping a New World

  Gil Y. Roth
  In July 2012, the U.S. Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which contained the Generic Drug User Fee Amendments (GDUFA). GDUFA has noble goals in its first five year term (FY 2013 - FY 2017): improving safety, access and supply chain transparency for generic drugs in the U.S.

• Understanding Special Protocol Assessments

  David Shoemaker, PhD
  The Guidance for Industry: Special Protocol Assessment (SPA) was issued in May of 2002, with the express purpose of enabling the Food and Drug Administration (FDA) to provide input into the design of certain studies critical to marketing approval prior to initiation.

• Process Characterization, Robust Optimization, and Quality by Design

  Scott M. Wheelwright, Ph.D.
  Several years ago I led a manufacturing team that was tasked with moving protein production processes out of development and into manufacturing.

• Selecting and Working with CMOs for Complex Formulations and Processes

  Greg Troiano, Donald Parsons, Christina Van Geen Hoven, Stephen Tuller, Jagannath Dey, Lia Brigida
  Over the past couple of decades, the pharmaceutical and biotech industries have trended towards increasing outsourcing of clinical and commercial materials and services.

• Becoming a Partner of Choice

  Andy Lee
  Imagine you are working or traveling away from your home when an emergency repair crops up. You can’t handle it personally, but you know someone who can – and one call to that person takes care of it.

• HORIZON LINES: A Yearly Review of NDAs – 2014

  Harshada Sant, MS
  A total of 133 NDAs were approved in 2014. This column summarizes details on all the NDAs (New Drug Applications) approved in 2014. The details on individual NDAs can be obtained from the articles listed in the reference section.