RECENT POSTS

WWL091719
Post by Barbara W. Unger | September 17, 2019

Week of September 8th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.

Jonathan Announcement
Post by Amy Filbin | September 16, 2019

Introducing Jonathan Rochez, Govzilla’s New VP of Engineering

Govzilla welcomes Jonathan Rochez as VP of Engineering.

JUUL
Post by Barbara W. Unger | September 11, 2019

CTP Issues First-of-a-Kind Warning Letter to JUUL Labs

JUUL Labs recently received a first-of-its-kind warning letter from CTP. Learn more about the warning letter and what makes it unique.

Amgen AI Part 1
Post by Jerry Chapman | September 10, 2019

Part 1: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

GMP expert Jerry Chapman covers how Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence.

Software Validation
Post by Barbara W. Unger | September 4, 2019

Identification of Software Validation Shortcomings

Software is used extensively in both the drug and device industry for computerized systems in manufacture and testing activities along with being used for building management control and equipment management control. GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.

WWL090319
Post by Barbara W. Unger | September 3, 2019

Week of August 25th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week, there were two warning letters issued to pharmaceutical firms.  But first, we address an EIR associated with AveXis and the second warning letter issued to a firm for failure to comply with the Food Foreign Supplier Verification Program.

Jane Wastl Announcement
Post by FDAzilla | August 29, 2019

Gaining GMP Expertise: Govzilla Adds Jane Wastl as Senior GMP Quality Expert

Govzilla announces the addition of Jane Wastl as Senior GMP Quality Expert to the Govzilla team.

FDA ARB Statement
Post by Jane Wastl |

Recent Statement Regarding ARB Recalls

Yesterday, Dr. Janet Woodcock, FDA Director of the Center for Drug Evaluation and Research, released a statement regarding the recent recalls of Angiotensin II Receptor Blockers (ARB).

Jerry Chapman Announcement
Post by FDAzilla |

Gaining GMP Expertise: Govzilla Adds Jerry Chapman as Senior GMP Quality Expert

Govzilla announces the addition of Jerry Chapman as Senior GMP Quality Expert to the Govzilla team.