- OBJECTIVE:
The purpose of this Standard Operating Procedure (SOP) is To describe the procedure for checking of analytical reports and raw data for correctness.
- SCOPE:
This SOP is applicable to the procedure for checking of analytical reports and raw data for correctness at Quality Control Department of manufacturing facility.
- RESPONSIBILITY:
- Analyst or his designee shall be responsible for follow the SOP.
- The Head of Quality Control Department or his designee shall be responsible for implementation of the SOP.
- PROCEDURE:
- The sample of the raw-material, intermediate or finished product will be analyzed by the analyst as per current Standard Test Procedure (STP). The analyst will record all raw-data in green test data sheet. All supportive print outs attached as the part of analytical report document. After completion of analysis, analyst will submit the analytical report along with remaining quantity of sample to the Executive Q.C / Manager Q.C.
- Executive Q.C / Section Head will check the analytical data for correctness as per attached checklist.
- Chromatograms of related substances / chromatographic purity test shall be zoomed.
Each peak shall be evaluated thoroughly for correct integration. Integration parameter
shall be decided based on nature of peak i.e. either valley to valley or base to base. So
estimation of impurity is correct.
- The final analytical report shall be compiled by Executive QC, Manager QC, Manager QA and the decision to approve / reject the material or product is recorded.
- TRAINING:
Trainer : Head – Quality Control
Trainees : Sectional Heads / Analyst / Officers
- DISTRIBUTION:
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Quality Control
Original Copy : Head – Quality Assurance
- ANNEXURE:
Annexure I:
- REFERENCES:
In-house
- REVISION HISTORY:
| Sr. No. | Revision No. | Change Control Number | Details of Revision | Reasons(s) for Revision |
| 1 | 00 | ———– | New SOP | New SOP |