SOP for Control of Master Data Generation by Computer System : Pharmaceutical Guidelines

SOP for Control of Master Data Generation by Computer System

Standard operating procedure to control the master data generated by the computers that control the instruments.

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 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 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 a 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 authorised 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 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 specification .
5.2.4  After release of the product enter the results in 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




Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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