SOP for Control of Master Data Generation by Computer System

1.0 OBJECTIVE

To have a better control over the master data generation system.

2.0 SCOPE

This procedure is applicable for of all master data generated from the computer for raw material and finished product.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 For Raw material section
5.1.1 On receipt of control copy of raw material specification from QA, enter respective specification in the computer as per the system available.
5.1.2 Take out the print of specification entered and get it checked by section incharge.
5.1.3 Take final print out & stamped it “APPROVED” & get sign of incharge. Preserve it as an approved copy.
5.1.4 Allocate the password to file and inform to section incharge, dept head and IT dept.
5.1.5 On receipt of the raw material for analysis, take print of blank COA of above specification and issue to concerned chemist duly authorized by section incharge with help of allocated password.
Related: SOP for Backup/Restore Analytical Data in Electronic Form
5.2 For Finished product section
5.2.1 On receipt of control copy of finished product material specification from QA, enter respective specification in the computer as per the system available.
5.2.2 Take print out of specification entered and get it checked by section incharge.
5.2.3 Allocate the password to file and inform to section incharge, dept head and IT dept. on finalisation of the specification .
5.2.4 After the release of the product enter the results in the computer for COA format and print the same.
5.2.5 Send the testing data sheet along with COA to section incharge for his signature.
Related: Audit Trail Requirements in Pharmaceuticals

6.0 ABBREVIATIONS

6.1 IT= Information and Technology
6.2 QA = Quality Assurance
6.3 COA = Certificate of analysis
6.4 SOP = Standard Operating Procedure
Also see: FDA’s Data Integrity Issues during Inspection of Indian Facilities

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