-->

      

Home

SOP for Out of Specification (OOS) for Pharmaceutical

Results

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

Pharmaceutical products and its investigation report during different stages.

Ankur Choudhary  Print  Question Forum  6 comments

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.

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
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:

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
 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: __________

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
 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 Sampled

By/Date: 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. TESTS of Releasing Parameters Sr. TESTS of Informative Parameters

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
 No. No.

1. Identification 1. Description

2. Assay 2. Particle Size Distribution (Sieve

3. Related Substances / Chromatographic 3. tests)

purity / Degradation profiles. 4. Bulk Density

4. Solubility Physical parameters (i.e.

5. Dissolution (USP guidelines to be Hardness, Friability, dimensions)

followed)

6. Content Uniformity (USP guidelines to

be followed.

7. Chemical purity tests (i.e. Melting

   points/ Colour index, chlorides/

8. sulphates, SOR, etc)

Text matters, Grammage, Colour

scheme.

 Get ready to use editable documents in MS-Word Format View List

Ankur Choudhary is India's first professional pharmaceutical blogger, author and

founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008.

Sign-up for the free email updates for your daily dose of pharmaceutical tips.

◉ Offline Need Help: Ask Question

« SOP for RLAF Unit in Sampling Room SOP for LAF Unit in Sampling Room »
6 comments: Post Yours!
Read Comment Policy ▼

vikas sogani 30 December

why oos is not applicable on sieve analysis

Reply Delete

Ankur Choudhary 31 December

@vikas Sieve analysis is an informative parameter and does not have any relation with product

quality.

Reply Delete

Muhammad Saidul Islam 01 August

The tensile strength (MD)of Film material is out of specification. is the OOS applicable here?

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
 Reply Delete

Muhammad Saidul Islam 01 August

the parameter tensile strength of film material is out of specification. is the OOS applicable here?

Reply Delete

M. K. Singh 21 November

Yes..In case of the parameter tensile strength also, OOS investigation(procedure) shall be applied.

Reply Delete

y chenna reddy 30 April

In case product changeover verification (rinse/swab)sample is failed, is it come under OOS.

Reply Delete

POPULAR CATEGORIES

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists

Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory

Maintenance Calibration Warning Letters Education B.Pharmacy

Resume Pro

CURRENT JOBS Post Job for

Free

Walk-in for Indoco Remedies Limited on 26/03/2023

QC Executive in Casper Pharmaceuticals

Officer QA in Marksans Pharma Ltd

Production Chemist in Sarv Bio Labs Pvt. Ltd.,

RESEARCH ASSOCIATE in Sarv Bio Labs pvt. Ltd.,

Executive/ Sr. Executive QA in Hetero Labs Limited

Walk-in for Alkem Laboratories Ltd. on 19/03/2023

Walk-in for BE Pharmaceuticals on 12/03/2023

Walk-in for MSN Laboratories on 07/03/2023

Research Associate / Senior Research Associate in Gracure Pharma

Show All ❭❭ Jobs by PharmaJobs

FOLLOW PHARMAGUIDELINE

 Like  Follow

 Follow  Follow

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
  Follow  Install

 Join


Get Free Updates
Subscribe

Enter your email Join

DOCUMENTS

PHARMACEUTICAL
DOCUMENTS

Editable Pharmaceutical
Documents in MS-Word Format.
Ready to use SOPs, Protocols,
Master Plans, Manuals and more...

View
adsbypg

GET APP FOR NEWS UPDATES

Pharmaceutical
Updates

✔ Worldwide Regulatory Updates

Instal
l

RECENT POSTS

GMP Violations at Indian Facilities

GMP Requirements in Pharmaceuticals

Writing Effective SOPs in Pharmaceuticals

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com
How to respond to an FDA 483 observations?

Preparing for FDA Inspections: Best Practices for Compliance

Out of Specification Investigation in Pharmaceuticals

Are You Ready for an FDA Inspection?

Importance of Cleaning Validation in Pharmaceutical Manufacturing

ABOUT PHARMAGUIDELINE

Pharmaguideline is a pharmaceutical blog where pharmaceutical concepts are explained in

very simple and easily understandable language for professionals and students. All articles and

SOPs are written by Ankur Choudhary.

OUR POLICIES

Privacy Policy

Terms and Conditions

Shipping and Delivery Policy

Cancellation and Refund Policy

CONTACT US

Email: [email protected]

Address: E449/2, Hardevpuri, West Jyoti Nagar, Shahadara, New Delhi, 110093

      

Convert web pages and HTML files to PDF in your applications with the Pdfcrowd HTML to PDF API Printed with Pdfcrowd.com