O Type - Impact Analysis

O Type Test : Impact analysis Date : 03-Nov-08 URS : RD/040 Specification Screen. ● ● ●

Provision of Mean LC% , Min LC% , Max LC% ,Standard deviation ,RSD % , Acceptance value to be report on COA, Analytical and worksheet report ?. One separate grid to specify Type of Formulation and it will print only in worksheet report User can select tablet or injection or capsule and accordingly title should be replaced. T = Target dosage content in LC% (default will be 100% or manually entered by analyst).

Analysis Screen. ● ● ● ● ● ● ●

Wt of Tablet title should be replace with “Wt of Tablet/Capsule/Vial/Other”. “Wt of empty Capsule/Vial/Other” to be incorporate. By default value is 0. “Content of capsule/Vial/other” to be incorporate. Content of capsule.... = Wt of Tablet...... - Wt of empty........ Mean, Min, Max, SD & RSD should be calculated for all above columns. For stage-1 k = 2.4 and stage-2 k = 2. This are constant value consider by system. S = Standard Deviation of LC%. Calculation: As per URS-RD/040

Table Structure ●

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PT_ANA_TEST_V → it holds sam_sys_num, atest_sys_num, lower & upper limit of O type test → Units to be taken, permitted deviation%, permitted units for stage-1, stage-2 and stage-3. PT_ATEST_VDETAILS → it holds Average, Max Deviation, Min Deviation and RSD of individual stage (For ex stage-1, stage-2 and stage-3.) PT_UNI_CONTENT → it holds individual unit's wt, %LC and %Deviation of Stage-1, Stage-2 and Stage-3.

Impact On : ● ● ● ● ●

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Specification Master Dummy sample registration Method revision. Import / Export Sample ○ Registration ○ Analysis ○ Checking ○ Release Working standard ○ Registration ○ Analysis ○ Checking ○ Release Test Limit Definition for SEL, SPC+ type Stability study pull out Reports ○ Analytical

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COA Worksheet Blank Template Stability Protocol Summary Report Summary report for RND Trend report.