- 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.
- 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.
Observation and Data recording Tables for UV Calibration – Attachment – I
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 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 2859-1:1999
SOP: Standard Operation Procedure
9.0 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