ARTICLES BY PETER H. CALCOTT

• 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.

• FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs

  5/4/2023

  In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.

• EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products

  1/18/2023

  The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

• FDA Finds Drug Shortages Are Mostly Caused By Quality Issues

  6/6/2022

  New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.

• What’s The Role Of Intuition When Making QRM Decisions?

  2/28/2022

  In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

• How To Set Up An Effective Quality Risk Management Program

  2/16/2022

  The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.

• 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations

  9/22/2021

  The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

• 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations

  9/15/2021

  Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

• A Tale Of Two Annexes: Analyzing EMA’s Revisions To Annex 1 & 13

  3/16/2018

  A Tale of Two Cities by Charles Dickens opens with the famous line, “It was the best of times, it was the worst of times.” This parallels two annexes recently updated by the European Medicines Agency (EMA) — one avoids the turmoil (Annex 13), while the other undergoes major upheaval (Annex 1).

• Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

  2/15/2017

  Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements.

• A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers

  6/21/2016

  The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.