- 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.
QC and QA Head shall be accountable that this SOP is implemented as per laid down 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:
Human Resource and administration
10.0 HISTORY OF REVISION:
Version No. Effective Date Reason for revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube