cGMP History

cGMP Adoption & Implementation


The adoption and implementation of cGMP’s proves to be a much greater challenge than what most manufacturers expected. As facilities began modifying and/or creating processes / procedures it became clear that compliance was to going to take years not months. Furthermore, the annual costs of compliance would be in the hundreds of thousands of dollars.  As the reality of time and investment necessary to achieve high level compliance became clear, the industries integrity and true level of commitment to quality were put to the test. Manufacturers had a decision to make and the results of those decisions would divide the industry’s manufactures into 3 basic categories of compliance.

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    Category 1: The Unwilling

    Manufacturers so set in their ways that they were and are unwilling to change.

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    Category 2: Willing but Unable

    We believe most manufacturers fall into this category. Because of their willingness to change these manufactures made great strides to increase their level of compliance but failed to complete the job when it came time to make the tremendous financial sacrifice associated with implementing potentially the most important part of the cGMP’s, the in-house analytical laboratory and/or contracting with outside labs.

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    Category 3: The Committed

    A small portion of manufacturers fully committed. They made and continue to make the financial sacrifices necessary to achieve compliance.

Division of Dietary Supplement Programs

By 2010, 2 years after the required compliance date for large companies, most of the industry had worked diligently to implement a good portion of the cGMP’s. As such one could say that overall, the average level of compliance had increased significantly. However, FDA inspections confirmed what most insiders already knew… While most companies were willing and successful at implementing many of the basic and less costly components of cGMP’s, the vast majority failed when it came time to making the financial sacrifices necessary to achieve high level compliance.

Compliance Level Variations – Cause for Concern

The dramatic differences between levels of compliance between companies of similar size and resources was concerning to the FDA and Industry leaders. The largest companies with the resources and the most to lose were struggling to compliance. With such a dramatic difference in compliance levels of large companies what would the spread be between large and small? It was clear that the Industry as a whole had a lot of work to do.

“It doesn’t seem that the firms are getting it.”Bradford Williams Manager of the FDA
“Just aren’t doing the testing” … FDA expects all firms test “every dietary ingredient that comes into their dietary facility.” Cara Welch, Ph.D., interim director of FDA’s Supplement Programs
“The rate of noncompliance in the dietary supplement industry remains too high.”Cara Welch, Ph.D., interim director of FDA’s Supplement Programs
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CURRENT STATE OF CGMP COMPLIANCE

5 Years & Only Modest Improvements

From, 2010 – 2015 The industry as a whole makes modest improvements year over year. However, a small percentage of companies excel. FDA inspections continue to reveal the failure of many companies to satisfy the basic tenants of the cGMP’s. The quality divide grows. The general consensus is that the best companies got better while the majority improved modestly. Common among Manufacturers who continue to excel at compliance are those who in the early years, 2007-2010 took on the difficult task of creating and/or expanded their in-house analytical laboratory or those who established successful relationships with 3rd party labs.


How This Affects You?

” …Thus, a firm that contracts with other firms… is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.”Excerpt from FDA Warning Letter Sent to Brand Owner

Our Opinion

As a manufacturer who is subject to the depth and scope of the cGMP’s we understand the challenges of compliance and to be frank, our expectation is that most FDA inspections will result in the identification of items of non-compliance. However, those items should be limited to the intricate details of the law, not failures to perform the basic tenants of the regulations.

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