SOP for Checklist for Analytical Raw Data Review (Chemical)

May 11, 2020January 27, 2023 Pharmaceutical Guidanace

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Checklist for Analytical Raw Data Review (Chemical).
2.0 SCOPE:This procedure shall apply to Quality Ccontrol of Pharmaceutical Company for Analytical Raw Data Review (Chemical)
.3.0 RESPONSIBILITY:
- All concerned personnel shall responsible to follow the procedure mention in this SOP.
- Concerned Department Heads shall be responsible for compliance of the procedure.
4.0 ACCOUNTABILITY:

QC and QA Head shall be accountable that this SOP is implemented as per laid down procedure.

5.0 ATTACHMENTS:

Not Applicable

6.0 PROCEDURE:

General Check Points

Analytical method, effective date, revision number.
Calibration status of Instrument
Instrument ID No.
Instrument usage log entry
HPLC/ UPLC/ GC /IC column ID number
HPLC/ UPLC / GC/ IC column usage log entry
Name and grade of reagents used in the analysis.
ID no. of buffer, reagents, volumetric, indicator.
The validity of the solution used in the analysis.
Solution ID no.
Working Standard /Reference Standard/Impurity name.
Working Standard /Reference Standard ID No./Lot No.
The potency of Working Standard /Reference Standard/Impurity
Working Standard /Reference Standard/Impurity validity date.
Balance ID used in the analysis
7.0 REFERENCES:ISO 2859-1:19998.0 ABBREVIATIONS:SOP: Standard Operation Procedure9.0 DISTRIBBUTION LIST:Quality AssuranceHuman Resource and administration
Production

Quality Control

Warehouse

Engineering

Purchase

10.0 HISTORY OF REVISION:

Version No. Effective Date Reason for revision

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