Content By The QA Pharm

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By: The QA Pharm

If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.

When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.

The responsibility of quality assurance is to ensure that an effective quality management system (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.

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By: The QA Pharm

Aquality management review of data with responsible company leadership is a current good manufacturing practices requirement. Quality management review procedures vary, but there seems to be a struggle with presenting data from across the quality management system in a meaningful and consistent manner when there are multiple contributors. Following are a few ways to organize your information in a more coherent fashion.

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By: The QA Pharm

Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the Federal FDCA, even if there is no affirmation of wrongdoing on the part of the manager individually.

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By: The QA Pharm

Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. It’s reasonable to assume that if a problem is worth solving, it’s also worth verifying that the solution worked. However, given the wide range of problems that could occur, determining the best verification approach and time frame to implement it can often seem elusive.

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By: The QA Pharm

When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.

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By: The QA Pharm

At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”

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By: The QA Pharm

At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: We must be okay; we have procedures for that.

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By: The QA Pharm

Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.

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By: The QA Pharm

This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address the possible violations in a sustainable way, and how to establish a method to guide the remediation work.

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By: The QA Pharm

Oftentimes pharma has a split personality. One personality loathes firefighting, and the other needs a burning platform to justify doing anything that requires spending money.

Go figure.