New USP Chapter: <1226> Verification of Compendial Procedures作者: 木槿 时间: 2011-11-5 15:48
Compendial methods such as USP and EP monographs are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance on what, when and how. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors got out and write 483's and warning letters related to <1226>. Now USP has announced to come out with a new revision by end of 2011 using the risk based approach for the type and extend of testing. Because there are no further guidelines there are still many questions." 作者: 木槿 时间: 2011-11-5 15:48
重回往日风云，再看2008年肝素钠事件。
下面是给常州SPL的警告信
In your March 17,2008, response to the FDA-483, you state that the firm has conducted suitability tests. In addition, you state that the test method was not verified because it was a basic cornpendial test. You assert that USP <1226>, Verification of Compendia1 Procedures, states that verification is not required for basic cornpendial test procedures that are routinely performed unless there is an indication that the compendial procedure is not appropriate for the article under test. In your response, you also state that the laboratory performed basic suitability testing on the heparin sodium API analytical method in accordance with your standard operating procedures (SOPS).
We disagree with your assertions that verification is not required for those USP test methods used by your firm. In accordance with cGMP, analytical methods should be validated unless the methods used are included in a relevant pharmacopoeia or other recognized standard reference. If the method is a cornpendial method, verification of the methods should be conducted to determine that the method is suitable for its intended use under actual conditions. We acknowledge that the USP informational chapter <1226> suggests that there is a lesser need for verification for the simplest tests such as loss on drying, residue on ignition, and pH measurements. However, these do not include the test methods at issue, including the protein test method. 作者: 木槿 时间: 2011-11-5 15:49
201106PDA大会技术presentation
USP Vision of Verification of Compendial Procedures
? Current Status
? Chapter <1226> has been official since 2006
? Requires verification that a compendial procedure is suitable
for its intended purpose under conditions of actual use
? Has been widely adopted by the industry
? Future Steps
? Encourage use of good scientific judgment and appropriate
risk assessment
? Consider verification as one facet of procedure lifecycle
? Potential for Toolkit or Informational Chapter to assist with
effective use of laboratory resources 作者: 木槿 时间: 2011-11-5 15:49
201106PDA大会技术presentation
USP Vision of Verification of Compendial Procedures
另：USP Vision of Transfer of Analytical Procedures 作者: 耗子=== 时间: 2011-11-5 15:55
Category II---- Analytical procedures for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These procedures include quantitative assays and limit tests.
图片附件: 19526181.gif (2011-11-5 15:49, 40.17 KB) / 该附件被下载次数 40
