 | Register Now! | | |
|
Want to post to the discussions? Comment on a Blog? Register Now.
|
|
|
| NPI Community Blogs | | |
|
|
|
|
|
|
Location: Blogs Analysis and Product Quality |
|
| Posted by: jhildreth |
10/9/2007 9:19 AM |
Many people do not realize that in the final GMPs there are specifications given for "reference standards" and the documentation that is required when using them for equipment calibration. Specifically they ask for the "certification of accuracy". The majority of materials supplied by commercial suppliers claiming to be reference standards do NOT have this type of proof or level of documentation. A product with a Certificate of Analysis is not the same as a "Certified Reference Material". To certifiy a reference material you must conduct numerous tests and follow a specific protocol such as ISO guide 31. If you ever purchase a Certified Reference Material from NIST or USP you will see just how much detail is in the Certificate of Analysis in order to comply with ISO.
Following is the GMP reference for those of you who like details and are interested in the exact wording and location etc.:
Subpart D – Equipment and Utensils
§ 111.35 Under This Subpart, What Records Must You Make and Keep?
(b)(3) Documentation of any calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement. In your documentation, you must:
(i) Identify the instrument or control calibrated;
(ii) Provide the date of calibration;
(iii) Identify the reference standard used including the certification of accuracy of the known reference standard and a history of recertification of accuracy;
(iv) Identify the calibration method used, including appropriate limits for accuracy and precision of instruments and controls when calibrating;
(v) Provide the calibration reading or readings found;
(b)(4) Written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment;…
|
|
| Permalink |
Trackback |
Comments (2)
|
Re: GMP Subpart D-Dcoumentation required for Reference Standards
|
By peter0805 on
5/6/2008 1:16 PM
|
|
was confused with Reference Standards and STD
|
|
|
How to test the Mogrosides and Mogrosides V in Luo Han Guo Extract
|
By peter0805 on
5/6/2008 1:37 PM
|
Luo Han Guo Extract is a natural sweeter with a very lower calorie, and it is a very healthy and will be very popular in Heathy supplement for amazing flavors and functional benefits. How to test the quality of Luo Han Guo Extract?
The active ingredients of Luo Han Guo is regarded as Mogrosides and Mogroside V brings more sweet taste with very less calorie. So we take the MMogrosides as the test STD:
Our test method of Mogrosides and mogroside V is listed as bellow:
|
|
|
|
|