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Life Science Training Institute > process validation
A Brief History Of Parenteral Process Validation — How We Got Here

Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

Posted in: Manufacturing,
Tags: guidances, process development, process validation,
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,
compliance
How Should I Respond To This FDA Warning Letter? (And Other Compliance Questions Answered)

Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today’s complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.

Posted in: FDA,
Tags: CGMP, compliance, FDA 483, inspection, process validation,

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