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

● 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 :

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