quality assurance

CHINA DRUG INSPECTIONS, 2016

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief China published their annual report of drug inspections 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 [...]

STARTING MATERIALS SELECTION and JUSTIFICATION

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 [...]

By | 2018-07-01T18:17:55+00:00 July 21st, 2017|Biopharma / Pharma, Clinical, FDAzilla, quality assurance|

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

*August 3 update: we added 2 additional warning letters that were released by the FDA after we published this post on July 12, 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, [...]

By | 2017-11-06T03:19:25+00:00 July 12th, 2017|FDA, FDA Inspections, FDA Warning Letters, FDAzilla, quality assurance|

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): […]

By | 2017-06-13T10:25:53+00:00 June 14th, 2017|FDA Inspections, FDAzilla, quality assurance|

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 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 [...]

By | 2017-09-15T21:58:53+00:00 June 13th, 2017|FDA, FDA Inspections, FDAzilla, Medical Devices, quality assurance|

28 Unique Data Integrity Deficiencies That Aren’t Really Unique

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief We’ve all been following the health authority’s identified deficiencies in data governance and data integrity for the last few years, though this enforcement action has been ongoing for almost twenty years.  A comprehensive GMP Intelligence program follows 483s and warning letters for information on the FDA’s focus.  Particularly in [...]

By | 2018-02-08T14:57:33+00:00 June 1st, 2017|FDA Inspections, FDAzilla, quality assurance|

FDA Sent These 7 Warning Letters for Pharma Companies | April 2017

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “products being misbranded” to sites “not ensuring that test procedures are scientifically sound.” From pharmaceuticals in India, Pennsylvania, and more, here they are (starting with the most recent): […]

By | 2017-05-10T10:11:28+00:00 May 10th, 2017|FDA Inspections, FDAzilla, quality assurance|

When Will the FDA Move On from Data Integrity?

The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it. Here is some troubling text from recent Warning Letters that cite data integrity: “…our investigator observed your [...]