- OBJECTIVE
To lay down a standard procedure for Analyst Validation.
- SCOPE
This SOP is applicable for Analyst Validation in Quality Control Laboratory
- RESPONSIBILITY
- Officers / Executive – Quality Control.
- ACCOUNTABILITY
- Manager-Quality Control and Head QA shall be accountable for compliance of this SOP.
- ATTACHMENTS
Format for Acceptance criteria of analyst qualification Attachment-I
Format for Qualification of analyst record for Assay Attachment-II
Format for test data sheet for analyst validation Attachment-III
- PROCEDURE
6.1 The analyst shall be validated for analytical techniques, which are coming under his / her responsibility.
6.2 Analyst those approved from FDA does not require qualification, but they can be evaluated for validation if required.
- Identify approved Raw material and Finished Product.
- Keep the record of material/Product name, Batch No., AR. No., Code No., and analytical value of sample along with acceptance limit as per Format-
- Assign appropriate Code No. to each sample identified for qualification as per given below:-
SOP/AV/PC-XXX
Where, SOP= Sano-Cito, AV=Analyst validation, PC=Product Code XXX =Serial No.
- Give sample for analysis appropriately coded in polybags /glass vial to analyst.
- Evaluate the Analyst either one or more, in following areas of analysis.
- Assay (Analysis to be carried out in triplicate).
- Identification by IR Spectrophotometer/Chemical basis.
- Loss on drying/ water content (in triplicate).
- Evaluate the Analyst for one or more of the following analytical method.
HPLC
U.V. Spectrophotometer
Titration
IR Spectrophotometer
- Evaluate the capability of the Analyst in terms of its precision to perform the tests and GLP followed by the Analyst.
- The capability to perform tests by Analyst shall be considered satisfactory if the results reported by the Analyst.
- Are within the acceptable limits as per Format-01.
- The Analyst complies with GLP.
- Document the results as per requirement in test data sheet for analyst validation as per Format-03.
- In case of assay for Raw material and Finished Product, compare all three results and find out RSD of results. The limit for RSD shall not be more than 1% for Raw Material and for Finished Product.
- Compare the average results with initial results. The difference between two results should not be more than 0.5% for HPLC and UV & ± 1% for titration.
- In case of IR analysis all three spectra shall match with Reference Spectra.
- For Qualification of Microbiologist, evaluate the microbiologist with respect to practices followed in the respective area like carrying out Microbiological Limit Test, Preparation of Culture, and Settle Plate etc.
- Qualify each new Analyst with in three months of the area of work given to them.
- Keep the details like calculations, chromatograms, and strip chart along with comments of department head in training file to be maintained separately for each Analyst.
- In case of Analyst found not qualified, re-train the Analyst and do not allot subjected work until he or she is qualified.
- Maintain records related to Training /Re-training and Re-qualification in training file.
- Prepare the final report as per Format-
- REFERENCES
In-house
- ABBREVIATIONS
SOP: Standard Operating Procedure.
QC: Quality Control.
HPLC: High Performance Liquid Chromatography
A.R. No.: Analytical Report Number
RSD: Relative Standard Deviation.
USP: United States Pharmacopoeia
FT: Format.
GLP: Good Laboratory Practices
QA: Quality Control
FDA: Food Drug Administration
- DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
- HISTORY OF REVISION
Version No. | Date of Revision | Reason for Revision |
Attachment-I
Sr. No. | Name of the Material | Batch No. | AR No. | New code No. | Analytical value of the sample along with acceptance limit | Remarks |
Name of the Analyst: ___________________ Date of validation: ___________
Code No. of sample: __________________ Type of sample: _____________
Test-I
1._________________ 2._________________ 3._________________ R.S.D.:____________( all 3 values)
|
Test-II
1._________________ 2._________________ 3._________________ R.S.D.:____________( all 3 values)
|
Test-III
1._________________ 2._________________ 3._________________ R.S.D.:____________( all 3 values) |
|
Limit: R.S.D.: NMT 1.0% for Raw material and Finished product.
Result between initial and observed is ±0.5% for HPLC & UV & 1.0% for titration & for loss on drying results between initial and observed is ±0.2% |
|
Overall Remarks: |
Verified by name: ____________________ Approved by: ___________________
Signature: ________________________ Signature: _____________________
Date: _____________________________ Date: __________________________