This document serves as a standard operating procedure (SOP) for managing out of specification (OOS) results encountered during the analysis of pharmaceutical products. Proper handling of OOS results is critical to maintaining product quality and compliance with regulatory standards.

Purpose of the SOP

The primary goal of this SOP is to establish a clear and consistent framework for addressing OOS results that arise during quality control testing. It is essential to identify, investigate, and resolve any discrepancies to ensure the integrity of pharmaceutical products.

Applicability

This SOP applies to the Quality Control Laboratory and covers OOS results for raw materials, packaging materials, and finished products specifically concerning releasing parameters. It does not pertain to informative parameters.

Roles and Responsibilities

Quality Control Analyst

Responsible for notifying the quality control in-charge upon identifying OOS results.

Quality Control In-Charge

Issues the OOS investigation form after documenting the incident in the OOS logbook.
Conducts a thorough investigation into the OOS results.

Quality Head

Reviews and verifies the OOS investigation form at each stage, providing final conclusions regarding the material's status.

Procedural Steps

Upon receiving an OOS report from the analyst, the following steps should be adhered to:

The Quality Control In-Charge will issue the OOS form and log the incident.
The QC In-Charge or their designee will initiate the investigation, completing Stage A of the OOS form.
If Stage A results are unsatisfactory, errors must be identified and corrected, followed by reanalysis of the same sample by a different analyst.
Should the material pass this reanalysis, it may be released, and the initial analyst should receive retraining on identified errors.
If Stage A results are satisfactory, the Supervisor will assign the sample for further analysis by a senior analyst (Stage B).
In Stage B, if results are within specification, the original analyst will reanalyze the same sample, and an investigation into their initial findings will occur.
If Stage B results are also satisfactory, the material may be released.
Should Stage B yield unsatisfactory results, a resample will be conducted under the supervision of the Quality Head (Stage C).
For Stage C, re-sampling must be authorised, and subsequent analysis will occur.
If no prior samples exist for comparison, the material will be rejected outright.
Should the previously approved material pass while the current sample fails, the latter will be rejected.
If both pass, a second analysis will be conducted by a different analyst, followed by a review as in Stage B.
Documentation of the repeat analysis must be maintained, and all relevant cross-references should be attached to the OOS investigation form.
Final conclusions regarding rejection or approval of the material will be recorded by the Quality Head.
Cross-references of the OOS investigation must be included in the analytical report.

Glossary of Terms

SOP: Standard Operating Procedure
OOS: Out of Specification

Attachments

General details relevant to the investigation process can be found in the following tables:

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

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)

Standard Operating Procedure for Managing Out of Specification Results in Pharmaceuticals