- 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
