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Inspection Preparation

/Inspection Preparation
Inspection Preparation 2018-02-14T11:42:35+00:00

  • The Ultimate Guide to Researching Your FDA Inspector

The Ultimate Guide to Researching Your FDA Inspector

February 9th, 2018|1 Comment

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably [...]

  • 10 Ways to Prepare for a GMP Inspection

10 Ways to Prepare for a GMP Inspection

January 26th, 2017|0 Comments

How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when [...]

3108, 2018

Week of August 19th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | August 31st, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Inspections, FDA Warning Letters|0 Comments

The FDA posted 4 warning letters this week -- 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. This week we also saw 2 untitled letters posted from inspections in 2016 (yes, 2 years ago). We cover all 4 in this post.

2908, 2018

Why Isn’t Paper the Same as Electronic?

By | August 29th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|0 Comments

Most of us feel comfortable with paper records. We like to think they’re the same as electronic records. But we hear rumblings from GMP inspections that FDA doesn’t always share that view. Let’s explore a simplified, hypothetical example to help you understand the importance of “content” and “meaning” and avoid an unnecessary 483.

2708, 2018

FINAL Part 2 | 2015 vs 2018 – MHRA Data Integrity Guidance

By | August 27th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections|0 Comments

The 2nd half of our dive into MHRA’s published revision to their 2015 Data Integrity Guidance. Changes are abundant when we compare the 2015 and 2018 versions. We share (in a clear table format) the final 23 updates along with our GMP expert’s conclusions.

2208, 2018

A Bad 483 Could Cost a Company Millions

By | August 22nd, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspection Stories, FDA Inspections, FDA Warning Letters, Food, Form FDA 483, Medical Devices, MOST POPULAR|0 Comments

I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.