OUT OF SPECIFICATION (OOS)

 

1.0  OBJECTIVE:

To lay down a 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 in-charge.

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 log book.

3.2.2        To investigate out of specification results.

4.0  ACCOUNTABILITY:

4.1  Head of the Q.C Department:

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 receipt of report for the out of specification (OOS) of results from the analyst, Q.C in-charge shall issue OOS form after duly entering in the out of specification log book.

5.2  Q.C 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, 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 superior shall allot the same material for re-analysis to another senior analyst (Stage B).

5.6  If (Stage B) result is within specification, the material shall be reanalyzed by first analyst with same sample material and to investigate the first analysts.

5.7  If investigation of first analysts found satisfactory then 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  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: GENERAL DETAILS.

Annexure 2:

 

Annexure: 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

Sr.#

Item

Observation

Sign

1.

Condition of sample to be checked.

 

 

2.

Balance checked for its calibration.

 

 

3.

Instrument calibration check.

 

 

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.

 

 

Remarks of the investigator: Not satisfactory/ Satisfactory.

Sign: _______________

Date: _______________

 

 

STAGE B

Repeat analysis allotted to:

Date:

Observation of the result:

 

Analyzed by: ________________ Date: _____________ Reference: _______________

Remarks 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

A.R. 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.

 

Annexure: 2

OOS Applicable

OOS Not Applicable

Sr. No.

Tests of Releasing Parameters

Sr. No.

Tests of Informative Parameters

1.

Identification.

1.

Description.

2.

Assay.

2.

Particle size distribution (sieve tests).

3.

Related substances/ Chromatographic purity/ Degradation profiles.

3.

Bulk density.

4.

Solubility

4.

Physical parameters (i.e. Hardness, friability, dimensions).

5.

Dissolution (USP guidelines to be followed).

 

 

6.

Content uniformity (USP guidelines to be followed).

 

 

7.

Chemical purity tests (i.e. Melting points/ colour index, chlorides/ sulphates, SOR, etc.)

 

 

8.

Test matters, grammage, and colour scheme.

 

 

 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

Sr. No.

Serial number

OOS

Out of specification

A.R. No.

Analytical report number

Qty.

Quantity

USP

United States Pharmacopoeia

 

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