1.0 OBJECTIVE: 1.1 The purpose of this SOP is to describe the procedure for checking analytical reports and raw data for correctness.
2.0 SCOPE: 2.1 This SOP is applicable to the procedure for checking analytical reports and raw data for correctness at the Quality Control Department of the manufacturing facility.
3.0 RESPONSIBILITY: 3.1 Analyst or his designee shall be responsible for following the SOP.
The Head of the QC Department/designee shall be responsible for implementing the SOP.
4.1 The analyst will analyze the sample of the raw material, intermediate or finished product as per the current Standard Test Procedure (STP).
4.2 The analyst will record all raw data in the green test data sheet.
4.3 All supportive print outs attached as the part of analytical report document.
4.4 After completion of the analysis, the analyst will submit the analytical report along with the remaining quantity of sample to the Executive Q.C / Manager Q.C.
4.5 Executive Q.C / Section Head will check the analytical data for correctness as per the attached checklist.
4.6 Chromatograms of related substances / chromatographic purity test shall be zoomed.
4.7 Each peak shall be assessed entirely for correct integration.
4.8 Integration parameters shall be decided based on the nature of the peak i.e. either base to base or valley to valley. So estimation of impurity is correct.
4.9 The final analytical report shall be compiled by Executive QC, Manager QC, and Manager QA, and the decision to approve/reject the material or product is recorded.
Trainer: Head – Quality Control
Trainees: Section Heads / Analysts / Officers
Controlled Copy No.1: HOD – Quality Assurance
Controlled Copy No.2: HOD – Quality Control
Original Copy: Head – Quality Assurance