- Objective: To lay down a procedure for Calibration of Gas Chromatography (GC).
- Scope: This Standard Operating Procedure is applicable for for Calibration of Gas Chromatography (GC).
- 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.
Production and QA Head shall be accountable that this SOP is implemented as per laid down procedure.
CALIBRATION OF AUTO INJECTOR BY LINEARITY (CAPILLARY COLUMN) – Attachment – I
CALIBRATION OF AUTO INJECTOR BY LINEARITY (CAPILLARY COLUMN)– Attachment – II
CALIBRATION FOR COLUMN OVEN TEMPERATURE– Attachment – III
GC CALIBRATION TEMPLATE FOR VIAL TEMPERATURE – Attachment – IV
- During calibration enter the details in the respective attachments of this SOP and compare the obtained results to the specified limits given in the respective template.
- If any noncompliance observed, inform to Head QC and follow the SOP on “ Handling of out of calibration.
- After completion of calibration submit the report for checking.
- affix the calibration status label on the instrument and records the details of calibration in respective logs after completion of calibration.
- Check and verified the leakage at the Joints with 50% v/v soap solution in water prior to use (Near septum nut, around injection port nut, at column connection).
- Calibration of Headspace incubator temperature and column oven temperature shall be preform by external party.
- For Calibration procedure and acceptance criteria refer respected calibration attachments.
- Calibration Frequency: monthly. (± 2 days)
- 7.0 REFERENCES:
- ISO 2859-1:19998.0 ABBREVIATIONS:SOP: Standard Operation Procedure9.0 DISTRIBBUTION LIST:Quality AssuranceHuman 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