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Life Science Training Institute > Resources > inspections
FDA And Quality Metrics: Where Do Things (Currently) Stand?

Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.

Posted in:FDA,Manufacturing,
Tags:API,inspections,quality metrics,
Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture

Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.

Posted in:FDA,Manufacturing,
Tags:data integrity,inspections,process validation,qualification,warning letters,
Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.

Posted in:Clinical,FDA,Manufacturing,
Tags:CGMP,compliance,inspections,laboratory operations,validation,violations,
7 Steps To Properly Navigate An Event Investigation

A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

Posted in:FDA,Manufacturing,
Tags:EI,event,FDA,GMP,inspections,investigation,MHRA,
Training
Training Your Personnel To Think Beyond The SOP

We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking.

Posted in:Manufacturing,Training,
Tags:biopharmaceutical,inspections,manufacturing,pharmaceutical,SOP,standard operating procedures,
What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?

This article discusses the most recent GMP inspection data from CDER and MHRA to help you with FDA inspection readiness plan.

Posted in:FDA,Manufacturing,
Tags:FDA,GMP,inspections,manufacturing,MHRA,
5 questions to ask yourself before the inspectors do

In order to measure your GMP compliance (and the effectiveness of your processes and people), ask yourself these five questions.

Posted in:FDA,
Tags:FDA,GMP,ICH Q10,inspections,

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