ARTICLES BY PETER H. CALCOTT

• EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides

  9/26/2024

  The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

• Strategies To Tackle CAR-T Product Challenges

  6/24/2024

  This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

• FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities

  12/5/2023

  In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

• 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).

• How To Catalyze & Sustain Continuous Improvement In Pharmaceutical Operations

  9/22/2017

  While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).

• Big Data & Leadership Strategies For Enabling Quality By Design

  8/14/2017

  The biopharmaceutical industry has unique commercial risks, including complex molecule products, costly supply chain infrastructure that takes a long time to construct, and raw material variations’ impact on process quality and yields.

• Rethinking Knowledge Management & Data-Driven Risk Management For Quality By Design

  6/30/2017

  In the first of a two-part article, we start by reviewing knowledge management (KM) and risk management (RM) approaches in the context of QbD and quality management systems (QMSs).