To lay down the procedure for Analytical Equilalence Of Powder Processing Operations.
1.0 PURPOSE
To lay down the procedure for Analytical Equilalence Of Powder Processing Operations.
2.0 SCOPE
2.1 This procedure is applicable in Quality Assurance, Quality Control, producton and Warehouse.
3.0 RESPONSIBILITY
3.1 Executive- Quality Assurance
3.2 Assistant- Quality Control
4.0 ACCOUNTABILITY
4.1 Manager – QA & RA
5.0 PROCEDURE
5.1 For all powder processing operations three lots are analysed completely and data collected.
5.2 The variation is analysis between the original analysis and the powder processed material is reviewed.
5.3 If the variation is within the limits as per the table below, the analytical data of powder processed material is considered equivalent.
5.4 Once the equivalence is established, the critical tests that need to be performed on powder processing are identified.
Table
|
S.No. |
Test |
Specification |
Variance permitted |
|
|
For all the tests, meeting the specifications and the following variance is considered |
||
|
01. |
Description |
|
Colour should not significantly change to darker plane |
|
02 |
Solubility |
|
Solutions should not be hazy as compared to original material |
|
03. |
Water (by KF) |
|
NMT ± 0.2 on absolute value |
|
04. |
Loss on drying |
|
NMT ± 0.2 on absolute value |
|
05. |
Related substances |
Individual Known impurity |
NMT ± 0.03 or LOQ on absolute value |
|
Individual unknown impurity |
New impurity at 0.05% level |
||
|
NMT ± 0.03 on absolute value |
|||
|
06. |
Assay |
By HPLC |
NMT ± 0.4 on absolute value |
|
By Titrimetry |
NMT ± 0.3 on absolute value |
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END OF DOCUMENT
Analytical equivalence, operations, quality assurance
