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SOP for Out of Specification (OOS)


Standard operating procedure to handle the out of specification results during the analysis of Pharmaceutical products.

1.0  PURPOSE

       The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for handling out of specification results obtained during analysis.

2.0  SCOPE

       This SOP is applicable to the results, which is out of specification obtained in Quality Control Laboratory for Raw / packaging materials, finished products for releasing parameters. This SOP is not applicable for informative parameters.

3.0  RESPONSIBILITY

3.1  Quality Control Analyst:
3.1.1  To inform out of specification results to the quality control incharge.
3.2  Quality control in-charge
3.2.1  To issue out of specification investigation form after entering in the form in out of specification logbook.
3.2.2  To investigate out of specification results.

4.0  ACCOUNTABILITY

4.1  Quality Head
4.1.1  To verify the investigation form at each and every stage and to give final conclusion about the status of the material.

5.0  PROCEDURE

5.1  On the receipt of report for the Out of Specification (OOS) of results from the analyst, Q.C. Incharge shall issue OOS form after duly entering in the out of specification log book.
5.2  QC In charge or designee shall carry out the investigation and fill in the form (Stage A).
5.3  If it is found that the parameter of stage A is not satisfactory, any error is reported, correct the parameter and same sample shall be reanalyzed by another analyst.
5.4  If the material meets the requirement (passes), release the material; the analyst shall be re-trained for the error parts.
5.5  If the parameter of stage A is found satisfactory, the Supervisor shall allot the same material for re–analysis to another senior analyst. (Stage B).
5.6  If (Stage B) result is within specification (passes), the material shall be reanalyze by first analyst with same sample material and to investigate the first analysts.
5.7  If investigation of first analysts found satisfactory than release the material.
5.8  If the material fails in Stage B also, by senior analyst, simultaneously analyse after re-sample with the previously approved material (Stage C).
5.9  Material under investigation (Stage C) should be re-sampled with the authorization of Head Quality and then proceeds for the further analysis  (Stage C)
5.10  If material has been received first time, no previous sample is available, than stage (C) is not applicable and rejects the material.
5.11  If the previously approved material passes within the specification and the material under investigation fails to meet the specification, the material shall be rejected.
5.12  If the previously approved material passes within the specification and the material under investigation also with the specification than the material shall be reanalyze by another analyst and investigate the second analysis (Stage B).
5.13  If investigation of second analysis (Stage B) found satisfactory than release the material.
5.14  The repeat analysis can be carried out in separate sheet allotted by the supervisor duly authorized or in the particular hard book and all printouts shall be attached with the document.
5.15  Cross-references of analysis shall be attached with OOS investigation form.
5.16  Final conclusion shall be made in the OOS investigation form for rejection / approval by Quality Head.
5.17  Cross-reference of OOS investigation form shall be given in the analytical report.

6.0  ABBREVIATIONS

6.1  SOP - Standard operating procedure
6.2  OOS - Out of Specification



                                                             ATTACHMENT – 1

                                                       GENERAL DETAILS  

Form No:
Issued by:
Issued to:
Date:
Product / Item:
Batch No. / Lot No.:
Stage:
Out of Specification Test:
Analyzed by: __________ Date: __________ Reference: __________
Details of Investigation
STAGE A:
S.No.
ITEM
Observation
Sign
1.
Condition of sample to be checked.


2.
Balance checked for its calibration.


3.
Instrument Calibration checked.


4.
Volumetric standard / reagent used for analysis checked for its validity.


5.
Analytical template/Hard book checked for dilution, calculation, weighing Titer values and readings.


6.
Working standard checked for its validity.


7.
Chromatograms / printouts / TLC plates checked


8.
Glassware checked for its accuracy and Calibration.


Remark of the investigator: Not Satisfactory/ Satisfactory
Sign: __________ Date: __________
Stage B
Repeat analysis allotted to:
Date:
Observation of the result:



Analyzed By: __________ Date: __________ Reference: __________

Remark of the investigator :



Sign:             __________ Date: __________

Note: If the material fails in the above stage i.e. Stage B, the material will resample with the authorization shall be Analyzed by Senior analyst along with the previously approved material.

MATERIAL /PRODUCT RESAMPLE AUTHORIZATION FORM

AR NO.:


QTY.:
Authorization
By/Date:
Sampled
By/Date:








                                                                    Stage C:                                                                                                  
Name of the Senior chemist:                                                   Date of analysis:
Approved batch taken for comparison:
Observation of the result:

Approved batch ():

Current Batch   ():


Analyzed By:__________          Date:__________          Reference:__________
FINAL CONCLUSION :


HEAD QUALITY: __________                                                             Date: _________


Attachments : Stage A __________
                      Stage B __________
                      Stage C __________
                      Investigation report

                                                                  ATTACHMENT – 2
OOS   APPLICABLE
OOS   NOT   APPLICABLE
Sr. No.
TESTS of Releasing Parameters
Sr. No.
TESTS of Informative Parameters
1.
2.
3.

4.
5.

6.

7.
  
8.


Identification
Assay
Related Substances / Chromatographic purity / Degradation profiles.
Solubility
Dissolution (USP guidelines to be followed)
Content Uniformity (USP guidelines to be followed.
Chemical purity tests (i.e. Melting points/ Colour index, chlorides/ sulphates, SOR, etc)
Text matters, Grammage, Colour scheme.
1.
2.
3.
4.


Description
Particle Size Distribution (Sieve tests)
Bulk Density
Physical parameters (i.e. Hardness, Friability, dimensions)




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