ARTICLES BY PETER H. CALCOTT
FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs5/4/2023
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 Products1/18/2023
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 Issues6/6/2022
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 Program2/16/2022
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 & Operations9/22/2021
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 & Operations9/15/2021
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 & 133/16/2018
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 Operations9/22/2017
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 Design8/14/2017
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 Design6/30/2017
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).
Measuring The Impact Of Recent Regulatory Guidances On Pharma Quality Systems4/3/2017
This article summarizes opinions on how well specific regulations have impacted operations and looks at the general health of some key quality management system (QMS) elements that are described and proposed in these regulations.
Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances2/15/2017
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.