SOP for Out of Specification (OOS) for Pharmaceutical Results

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 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 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 a final conclusion about the status of the material.

5.0 PROCEDURE

5.1 On the receipt of the 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 the 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 reanalysis to another senior analyst. (Stage B).
5.6 If (Stage B) result is within specification (passes), the material shall be reanalyzed by the first analyst with same sample material and to investigate the first analysts.
5.7 If the investigation of first analysts found satisfactory then release the material.
5.8 If the material fails in Stage B also, by senior analyst, simultaneously analyze 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 the material has been received the first time, no previous sample is available, then 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 reanalyzed by another analyst and investigate the second analysis (Stage B).
5.13 If the 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 to 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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