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Life Science Training Institute > inspections
Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance

This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

Posted in: Manufacturing,
Tags: CGMP, compliance, inspections, QMS, quality culture,
Understanding 2019 FDA Enforcement Trends — And What They Mean For 2020

The FDA conducted a total of 18,034 inspections in FY2019, off which 6,434 were inspections of biologics, medical device, or drug companies. Those inspections resulted in the issuance of 15,015 warning letters, a slight increase over 2018. The FDA also increased its import alerts, publishing 98 in 2019. This corresponded with a decrease in injunctions and seizures, showing the FDA’s preference for earlier preventive measures over later involvement.

Posted in: FDA, Manufacturing,
Tags: FDA, form 483, inspections, warning letters,
U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report

Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

Posted in: FDA, Manufacturing,
Tags: GMP, GMP compliant, inspections, warning letters,
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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