<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

At the International GMP Conference held virtually in March 2022 and co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain, Ileana Barreto-Pettit, presented in-depth case studies from recent drug GMP inspections that illustrate agency findings and concerns. In a four-part series of articles, Redica Systems Senior […]

With 483s from a key set of human clinical study inspections, we used the Redica Systems Expert Model for GCP to show how many inspector observations involving “Responsibilities of the Investigator” fit into several useful subcategories that provide actionable insight for your operations. “Responsibilities of the investigator” was the largest major category of observations in […]

GMP Case Studies Presented by FDA Investigator Ileana Barreto-Pettit: Part IV Stainless steel perforated cleanroom tables are designed to allow vertical airflow through the table and prevent stagnant pockets of air. However, when using perforated tables or work surfaces, the room airflow pattern and cleanability are often facets that are not fully evaluated and may […]

Data integrity is a standout observation in 483s as revealed by the Redica Systems expert model for GCP from a key set of human clinical study inspections. This is the first in a series of articles on using artificial intelligence (AI) to identify trends in GCP inspections. Part II addresses “responsibilities of the investigator” 483 […]

*Author’s Note: We’ve updated this post with fresh up-to-date data from the Redica Systems dataset, in the last section titled Issues with HEPA Filters Continue* GMP Case Studies Presented by FDA Investigator Ileana Barreto-Pettit: Part III During an inspection of a firm performing aseptic manufacturing of sterile products, FDA investigators observed HEPA filters in the […]

  GMP Case Studies Presented by FDA Investigator Ileana Barreto-Pettit: Part II Execution of proper cleaning regimens and cleaning validation continue to be problematic in the pharma industry and the subject of FDA Warning Letters. Why do these practices continue to be deficient after being cited in Warning Letters over many years? And how can […]

GMP Case Studies Presented by FDA Investigator Ileana Barreto-Pettit: Part I Why were change management failures involving starting material cited in an FDA Warning Letter? Relying on information from laboratory-scale batches instead of full-scale validation batches plus failure to test validation batches of API for specific impurities drew the attention of FDA investigators. [Related: Click […]

Outsourcing of pharmaceutical manufacturing to contract manufacturing organizations (CMOs) has grown as companies seek to deliver medicines to patients at an increased pace. Emma Ramnarine, Executive Director and Global Head of External Development Collaborations at Genentech/Roche, spoke at the 2021 PDA/FDA Joint Regulatory Conference about how approaching these partnerships with a quality risk management (QRM) […]

At the 2021 PDA/FDA Joint Regulatory Conference, FDA Director for the Division of International Drug Quality Carmelo Rosa provided a regulatory perspective on quality systems, including key inspection trends in this area. [Related: Prepare for your next FDA inspection by downloading a FREE analysis of FDA Warning Letters from FY2020 and FY2021 by GMP Consultant […]

Do your suppliers and contract manufacturing organizations (CMOs) have robust GMP CAPA effectiveness? How can you ensure that your external partners adhere to manufacturing quality requirements? [Related: Check out the top 483 observations for two of the leading CMOs for a three-year period. Download this FREE analysis here.] During a session at the 2021 PDA/FDA […]