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Reports on key industry issues by our GxP Experts

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Conference updates from Jerry Chapman

Enforcement

Search posts on Warning Letters and 483s

Recent Posts

Line of Insulin Vials

Highlights from Recent FDA Inspections of Vendors/Suppliers

Companies that use contract manufacturing organizations (CMOs) are ultimately responsible for ensuring product quality and compliance to GMPs. Thus, it pays in more ways than one to be aware of recent FDA quality-related citations at CMOs and other vendors.

OTC pills

FDA Warning Letters Week Of 9/6/2020: Data Integrity Failures & Lack of Cleaning Validation

FDA posted two Warning Letters issued to pharma companies for GMP violations last week. One cited data integrity failures among other observations at an OTC manufacturer while the second cited a drug repackager for cleaning validation issues. Interestingly, cleaning validation (or lack thereof) was a focus of one of the previous week’s Warning Letters.

Globe Showing Latin America

CMC Challenges and Opportunities in Latin America

The Latin American region of the globe—which includes large countries such as Brazil, Mexico, Argentina, Columbia, and Peru—is undergoing a transformation marked by the stepwise harmonization of pharmaceutical regulations with international norms and standards. While it is a slow process and each country’s regulatory agency faces its own unique journey, progress is being made.

Papers on a Table

The FDA Inspection is Over: What Happens Next?

In this conclusion to the four-part series summarizing Steven Niedelman’s May 28 Govzilla webinar presentation on FDA inspections, Niedelman outlines the steps following the conclusion of an FDA inspection. Part I provided background on FDA inspection authority while Part II looked at the different types of inspections FDA conducts. Part III offered advice on interacting with FDA investigators once they are onsite.

Capsules

FDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues & Adulterated Products at CMO

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.

The FDA Inspection Has Begun: Now What?

So, FDA investigators are at the gate. What can you expect during the inspection? And how can you prepare in advance to ensure a smooth inspection?

Pharmaceutical Packaging Line

Why Your FDA Inspection History is Important

FDA conducts three main types of inspections. Preapproval inspections generally support New Drug Applications (NDAs), Premarket Approvals (PMAs), and licensing agreements.

RECENT POSTS

Globe Showing Latin America

CMC Challenges and Opportunities in Latin America

The Latin American region of the globe—which includes large countries such as Brazil, Mexico, Argentina, Columbia, and Peru—is undergoing a transformation marked by the stepwise harmonization of pharmaceutical regulations with international norms and standards. While it is a slow process and each country’s regulatory agency faces its own unique journey, progress is being made.

Read More »
Papers on a Table

The FDA Inspection is Over: What Happens Next?

In this conclusion to the four-part series summarizing Steven Niedelman’s May 28 Govzilla webinar presentation on FDA inspections, Niedelman outlines the steps following the conclusion of an FDA inspection. Part I provided background on FDA inspection authority while Part II looked at the different types of inspections FDA conducts. Part III offered advice on interacting with FDA investigators once they are onsite.

Read More »
Capsules

FDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues & Adulterated Products at CMO

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.

Read More »

RECENT POSTS

Globe Showing Latin America

CMC Challenges and Opportunities in Latin America

The Latin American region of the globe—which includes large countries such as Brazil, Mexico, Argentina, Columbia, and Peru—is undergoing a transformation marked by the stepwise harmonization of pharmaceutical regulations with international norms and standards. While it is a slow process and each country’s regulatory agency faces its own unique journey, progress is being made.

Read More »
Papers on a Table

The FDA Inspection is Over: What Happens Next?

In this conclusion to the four-part series summarizing Steven Niedelman’s May 28 Govzilla webinar presentation on FDA inspections, Niedelman outlines the steps following the conclusion of an FDA inspection. Part I provided background on FDA inspection authority while Part II looked at the different types of inspections FDA conducts. Part III offered advice on interacting with FDA investigators once they are onsite.

Read More »
Capsules

FDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues & Adulterated Products at CMO

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.

Read More »