FDA proposed GMPs

Alternative Medicine Review,  Dec, 2004  

• E-mail
• Print
• Link

[68 Federal Register 49:12157, at 12197-12198: March 13, 2003]

"For those specifications that we tentatively have determined are necessary (identity, purity, quality, strength, and composition) at receipt, in process, and finished product stage, we are proposing specific testing requirements that provide some flexibility. Under Sec. 111.35(g)(l), we would require that you test each finished batch of the dietary ingredient or dietary supplement produced before releasing for distribution to confirm that specifications are met for the identity, purity, quality, strength, and composition intended, provided that there are scientifically valid analytical methods available to perform such testing. We recognize that certain tests for identity, purity, quality, strength, or composition for certain finished product may not be available due to complex finished matrices that would make such testing impracticable. Further, even though there may not be a scientifically valid analytical method that you could use to provide you with the information to evaluate, for example, the identity and composition of the finished product, there may be methods available for testing at the finished product stage for other required specifications of purity, quality, and strength. Under proposed Sec. 111.35(g)(3), your quality control must document that a scientifically valid analytical method is not available to perform finished product testing for any one of the required specifications for identity, purity, quality, strength or composition.

"If your quality control unit documents that a scientifically valid analytical method for testing each batch of dietary ingredient or dietary supplement is not available for any one of those required specifications, then you would be required, under Sec. 111.35(g)(2)(i) and (g)(2)(ii) to test incoming shipment lots of components, dietary ingredients, or dietary supplements for any such specification to determine whether it is met and to test in-process for any such specification in accordance with the master manufacturing record where control is necessary to ensure the identity, purity, quality, strength, and composition of dietary ingredients or dietary supplements.

"If you are able to perform testing on each finished batch of dietary ingredient or dietary supplement to confirm that specifications are met for the identity, purity, quality, strength, and composition intended, then we would recommend, but would not require, that you also test materials received for these same specifications to ensure that they are the right ingredients and so that you do not end up having to destroy an entire batch of finished product after using an erroneous ingredient that could have otherwise been identified earlier before being added to a batch.

"Proposed Sec. 111.35(h) would require that you use an appropriate test or examination to determine whether your specifications are met. An appropriate test is one that is a scientifically valid analytical method. If there is an AOAC or FDA method available that is appropriate for your purpose, you should use that test method. For example, if your dietary supplement claims to contain vitamin C, there is a specific test for identifying vitamin C, and so proposed Sec. 111.35(h) would require that you use that test (Ref. 68). If an AOAC or FDA rnethod is not available, a scientifically valid analytical method is one that is based on scientific data or results published in, for example, scientific journals, references, textbooks, or proprietary research. While there may not be an AOAC or FDA method available, we are not aware of a situation where an appropriate scientifically valid analytical method is not available. You could perform the tests yourself or have someone perform these tests for you."

[68 Federal Register 49:12157, at 12207; March 13, 2003]

"One comment to the ANPRM recommended that the regulations related to laboratory operations apply to laboratory facilities located and operated within a company and those facilities that a company may contract with that are located elsewhere. Proposed Sec. 111.60(a) would apply to laboratory facilities generally and is not restricted to laboratory facilities located and operated within a company. In other words, even if you hire a private laboratory to perform various tests for you, proposed Sec. 111.60(a) would require that you make sure that the private laboratory's facilities are adequate to perform whatever tests are necessary. The most important point in proposed Sec. 111.60(a), however, is not where the facility is located, but whether the laboratory facility is adequate for the tests and examinations that need to be done.

[68 Federal Register 49:12157, at 12208- 12209; March 13, 2003]

"Proposed Sec. 111.60(b)(iv) through (b)(vi) would require... Use of appropriate test method validations. Test method validation determines whether a newly-developed or existing test method is accurate, precise, and specific for its intended purpose. We have discussed previously the terms "accurate" and "precise." Validation involves evaluating the test method on multiple occasions or in multiple test facilities. Official methods, such as AOAC International methods, are validated in collaborative studies using several laboratories under identical conditions. The AOAC International methods that are validated in collaborative studies are often cited as "official validated methods." ...