GMP Regulatory Newsletter: Summary Scan | Week of 7/8/18
Laws, Regulations, Guidance, and Concept Papers FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and have been promised by FDA. Another 2 guidance were [...]
Follow the Trail to Find Data Integrity Problems
How Do I Follow The Trail? One of the most effective audits I ever participated in [...]
FDA Sent These 4 Warning Letters for Food Companies | June 2018
We took a snapshot of the 4 warning letters the FDA sent to food companies last [...]
PHARMA/BIOTECH
- Expert Guidance from Barb Unger
- FDA Guidance
- Tips on Supplier Management
- More…
MEDICAL DEVICE
- Warning Letters
- FDA Guidance
- Data Integrity
- More…
FOOD
- FSMA
- Inspection Prep
- Tips on Supplier Management
- More…
INSPECTION PREPARATION
The Ultimate Guide to Researching Your FDA Inspector
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 [...]
New FDA GMP Inspection Model
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 [...]
10 Ways to Prepare for a GMP Inspection
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 [...]
POPULAR POSTS
FSMA Has Arrived – Here’s What We Know So Far
Since the introduction of FSMA in 2011, the FDA issued new guidance to the Food Industry for GMP and HARPC (Hazard Analysis and Risk-Based Preventive Controls). This guidance was encapsulated in 21 CFR 117, which is slated to replace 21 CFR 110. The biggest difference in 21 CFR 110 and 21 CFR 117 is [...]
Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?
by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas. Let’s talk about activities in the GMP area. Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be [...]
A Bad 483 Could Cost A Company Millions
“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.” I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world. While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483. And [...]
Does an FDA Import Alert automatically equate to an impending FDA Warning Letter?
by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs […]