How do you test blend uniformity?
This method is used to demonstrate blend uniformity using dosage unit results. For example, a tablet with potency of 19.4 mg and weight of 98 mg = 19.4 ÷ 98 = 0.198 mg/mg. Label claim is 20 mg per each 100 mg tablet, so the weight corrected result is 0.198 ÷ 0.20 * 100 = 99% of target blend potency.
What is meant by blend uniformity?
Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue. No method is developed yet to determine the uniformity of blend during the mixing.
What is VCA in blend uniformity?
1 The FDA also expects that variance component analysis (VCA) be performed on the data to demonstrate uniformity of the mix throughout the blender. Within-location variance assesses the variability of replicate samples within a single location.
What is the difference between assay and blend uniformity?
The main difference between content uniformity and assay is that content uniformity is a test in which evaluation units are done individually whereas assay is a test in which multiple units are done simultaneously.
What is the limit of blend uniformity?
The statistical tolerance limits are constrained within 85.0% and 115.0% of blend uniformity, meaning that there is a 95% chance that a minimum of 90% of the blend is within 85.0% and 115.0% (see Fig. 1).
What is limit of uniformity of content as per USP?
The requirements are met if not more than 1 unit of the 30 is outside the range of 85.0% to 115.0% of label claim, and no unit is outside the range of 75.0% to 125.0% of label claim and the RSD of the 30 dosage units does not exceed 7.8%.
How is content uniformity measured?
The test for uniformity of content of single-dose preparations is based on the assay of the individual contents of active substance(s) of a number of single-dose units to determine whether the individual contents are within limits set with reference to the average content of the sample.
How do you calculate Av value in content uniformity?
Calculate the acceptance value (see Table 6.02-2.). Calculate the acceptance value by the formula: | M － X . | ＋ ks, in which the terms are as defined in Table 6.02-2.
What is the difference between content uniformity and weight variation?
Content Uniformity is the default test and may be applied in all cases. The test for Weight Variation is applicable for dosage forms specified as W1, W2, W3, and W4. The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1%.
Why do we use uniformity test?
Content uniformity is one in a series of tests in a therapeutic product specification that assesses the quality of a batch. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within specified acceptance limits.
Do CGMPs need three successful process batches?
5. Do CGMPs require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? No. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process.
How is unit dose sampling procedure for evaluation of blend uniformity performed?
Unit dose sampling procedure for evaluation of blend uniformity shall be performed at appropriate phases of manufacturing using a SS316 cylindrical unit dose sampling thief with removable dies. Unit dose samples for the evaluation of blend uniformity shall be collected in duplicate. One set of samples shall be submitted to QC for analysis.
How do you remove a sampling thief from a blend?
During resampling, the sampling thief shall be reinserted vertically, adjacent to the point through which it was inserted during first sampling. If the blend sample adheres to the die cavity, gently tap the die or remove contents with the help of a clean piece of butter paper.
What should be done if blend uniformity fails?
If blend uniformity fails then a stratified sampling of finished product shall be done and Uniformity of dosage unit test shall be performed. Stratified In-process dosage unit sampling shall be done. Extensive sampling in case of event batches. Stratified in-process dosage unit sampling shall be done.
What is SOP cleaning of unit dose sampling thief?
Officer – QA shall ensure that the unit dose sampling thief and the respective dies are cleaned as per SOP ” Cleaning of unit dose and large volume sampling thieves”. Officer – QA shall identify each tared butter paper/Glass vial with the location of sampling.