SOP for Calibration of UV spectrophotometer.

May 11, 2020January 27, 2023 Pharmaceutical Guidanace

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Calibration of UV spectrophotometer.2.0 SCOPE:This procedure shall apply for Calibration of UV spectrophotometer in quality control departments
.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:

Observation and Data recording Tables for UV Calibration – Attachment – I

6.0 PROCEDURE:

General Procedure for UV Spectrophotometer

All calibration standards used for the calibration should prepared as per template / SOP.
Only use calibration standard which is procured from authentic source with certification and it should
NIST traceable or Pharmacopoeial reference standards or From instrument manufacturer.
Alternatively suitable commercial certified filters (NIST traceable) may be used.

Internal Calibration:

Internal calibration should perform for the parameters mentioned in Attachment for Internal calibration observation sheet.
Perform the internal Calibration as per manufacturer’s instruction.
After completion of internal calibration the results obtained shall fill in Attachment -Internal calibration observation sheet, the format may differ base on manufacturer’s internal calibration requirement) for further evaluation and conclusion.

Note : Perform the internal calibration of UV Spectrophotometer, if option available in software

7.0 REFERENCES:ISO 2859-1:19998.0 ABBREVIATIONS:SOP: Standard Operation Procedure9.0 DISTRIBBUTION LIST:Quality Assurance
Human 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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