CHINA DRUG INSPECTIONS, 2016

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

China published their annual report of drug inspection for 2016 on June 2, 2017.  The 31-page document reports on a variety of inspection types including but not limited to: pre-approval inspections, GMP certification inspections, and GMP follow-up inspections.  The report is accompanied by tables and figures.  For the most part, it is easily understood, but where discrepancies seem to appear between the various values and terminology, I’ve highlighted the uncertainty.  Some types of inspections are absent here but the report provides specific details on the inspections and the deficiencies identified.

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STARTING MATERIALS SELECTION and JUSTIFICATION

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

The EMA published a reflection paper on July 3, 2017, that addresses ‘the requirements for selection and justification of starting materials for the manufacture of chemical active substances.’  The intent of the reflection paper, prepared by the Quality Working Party, is to clarify expectations outlined in ICHQ11, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological / Biological Entities’.  This document covers both human and veterinary medicinal products.  ICH issued a Q&A regarding the selection and justification of starting materials and the most recent draft is dated October 13, 2016. This reflection paper provides additional granularity on expectations of the EU regulatory authority beyond what is found in the ICH Q&A. Taken together, the reflection paper can be summarized as being ‘all about impurities’, both known and unknown. It also targets catalysts, solvents, and regents that are used in manufacture of starting materials and how they are controlled to ensure consistent manufacture of the active substance.

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FDA Sent These 5 Warning Letters for Pharma Companies | June 2017

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “misbranded products” to sites “failing to investigate the unexplained discrepancy.”

From pharmaceuticals in China, Texas, and more, here they are (starting with the most recent):
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FDA Sent These 6 Warning Letters for Pharma Companies | May 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to establish adequate written procedures to not submitting periodic adverse drug experience reports.

From pharmaceuticals in New Jersey, China, and more, here they are (starting with the most recent):
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6 Key Take-Aways from the 2016 EMA Annual Report

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

The EMA published their Annual Report for 2016 in May 2017, and it provides highlights of their work in partnership with the national health authorities.  Christa Wirthumer-Hoche, chair of the EMA Management Board, provides the Forward to the report, and Guido Rasi, the EMA Executive Director, provides the Introduction.  The report identifies important activities in 2016 and how they advance public health.  It also holds a collection of graphics from a variety of areas including human and veterinary medicines, the European regulatory network, and inspections/compliance. The report also identifies 22 Annexes that may be found on the Agency’s website but are not included in the report.  

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The FDA Re-Org Has Begun. What Does it Mean for You?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

BACKGROUND:

The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.

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