quality assurance

20 11, 2017

Generic Drugs | A Guidance on FDA Guidance

By | 2017-11-20T21:25:32+00:00 November 20th, 2017|Biopharma / Pharma, FDA, FDA Enforcement News, FDA-Regulated Industry, FDAzilla, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief On November 1, 2017, we published a blog that addressed a large collection of newly issued guidance for the generic drug industry.  With this post, we continue with another three generic drug guidance that were issued recently.  Consistent with the previous collection, many of these find their roots in [...]

1 11, 2017

Recent Generic Drug Guidance

By | 2017-11-06T01:19:55+00:00 November 1st, 2017|Biopharma / Pharma, FDA, FDAzilla, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief October has so far seen a flurry of guidance publications focused on generic drugs.  It’s unusual to see so many guidance on one kind of product published almost simultaneously — though the device area seems to be making the same effort!  Many of the generic drug guidance are published [...]

25 09, 2017

The Heightened Importance of Contract Manufacturing Organizations

By | 2017-11-27T11:26:41+00:00 September 25th, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals.  Hovione Pharmaceuticals offers a range of contract services including but not limited to, product development, manufacturing of API and drug products, and analytical support. [...]

25 09, 2017

New FDA GMP Inspection Model

By | 2018-02-14T11:48:18+00:00 September 25th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted.  The FDA recently made available a description of their new operating model that will ensure integration of review and inspection [...]

20 09, 2017

FDA Sent These 11 Warning Letters for Pharma Companies | August 2017

By | 2018-02-01T11:34:07+00:00 September 20th, 2017|Biopharma / Pharma, FDA, FDA Warning Letters, quality assurance|

We took a snapshot of the 11 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to keep drug product infestation free to failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the proper education, training, and experience. From pharmaceuticals in China, Georgia, [...]

23 08, 2017

Summer Enforcement Actions for Compounding Pharmacies and Outsourcing Facilities

By | 2017-12-01T22:02:49+00:00 August 23rd, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief July and early August 2017 saw another uptick in FDA actions associated with compounding pharmacies/outsourcing facilities.  In the past few years, the FDA has placed a disproportionate effort towards enforcement actions for these facilities.  We have addressed this focus and the history of these facilities in a previous blog. [...]

22 08, 2017

US-EU Mutual Recognition Agreement of 2017

By | 2018-02-16T13:19:13+00:00 August 22nd, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, Medical Device - Featured, Medical Devices, quality assurance|

A Long Time in the Works by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the US FDA and the European Union (EU) inspectorates has been in the development since 1998 and was formalized this year. This agreement was driven by [...]

17 08, 2017

FDA Issued 48 Product Recalls, Import Alerts, and Consent Decrees in July 2017

By | 2017-12-01T22:04:58+00:00 August 17th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Inspections, Medical Devices, quality assurance|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

16 08, 2017

FDA Sent These 9 Warning Letters for Pharma Companies | July 2017

By | 2017-12-01T22:06:04+00:00 August 16th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Inspections, FDA Warning Letters, quality assurance|

We took a snapshot of the 9 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “adulterated and misbranded drug products” to sites “failing to sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.” From pharmaceuticals in Italy, Tennessee, and more, here they are (starting with the most recent): [...]