Compliance

20
Jul
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

ED and Weight Loss Supplements – Stand Up and Take Notice

The dietary supplement market is notorious for issues associated with the inclusion of not-permitted ingredients in marketed supplements.  Kratom is a recent poster child for this issue, but the erectile disfunction and weight loss markets both seem to have extraordinarily bad compliance and enforcement histories.  These two disease states comprise the lion’s share of Warning […]

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14
Jul

Compounded Drug Surveillance – Mitigation of Risk Is the Payoff

Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here)  which provides an overview of FDA’s Compounding Incidents Program.  It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]

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05
Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

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01
Jul

Continuous Manufacturing vs. Batch Manufacturing – Where Will the Industry Go?

In a recently released publication on the FDA website entitled, An FDA Self-Audit of Continuous Manufacturing for Drug Products (here) the FDA relayed its experience with some quantified data and some estimates of savings from the use of the continuous manufacturing (CM) vs. batch manufacturing (BM) albeit, from a limited number of applications. Key take […]

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01
Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

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30
Jun

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]

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23
Jun

Beta‑Lactam Antibiotics 2013 Guidance for Preventing Cross Contamination Hits the Street

The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products.  Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]

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14
Jun
Young man looks at road map near on mountain road, Switzerland

To Measure or Not to Measure, Quality Metrics Is the Question!

The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion.  People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation.  Thus, quality metrics were held tightly close to the chest of business leaders.  Deming identified this […]

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