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Five Obstacles to Managing a Pharmaceutical Quality System, Part 3

Inadequate management review of quality management system performance

The QA Pharm
Tue, 08/27/2013 - 17:05
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Editor’s note: This is the third in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.

In part one of this series, we considered the management perception that current good manufacturing practices (cGMPs) aren’t relevant to the business, and laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well. Part two explained how the quality function was in the best position to defend the relevance of cGMPs, but all too often it has problems of its own and should be the focus of serious organizational development. Here we make the case for a data-rich source of feedback to determine how effective the quality system is. Otherwise one is flying blind.

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Comments

Submitted by RHWoodman on Tue, 08/20/2024 - 15:27

Parts 4 & 5?

Were parts 4 and 5 of this series never written? never published? published and later deleted?

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Submitted by Quality Digest on Tue, 08/20/2024 - 15:54

In reply to Parts 4 & 5? by RHWoodman

Parts 4 and 5

Very old article (2013). But from what I can find, there is no part 4 or 5. Could be the author had planned on 5, but then just stopped.

If you want to see all articles by this author, you can just click on the author name.

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