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Microbiology Out of Specification (OOS) Investigation and Report Form

This 3-page document is a form used to report microbiology out-of-specification (OOS) test results. It includes sections to document the product and test details, evaluate the initial test and laboratory testing process, determine if the initial result is valid, and outline any retesting protocols. The form requires documentation and approval of test deviations, investigation findings, retest methods and results. It aims to thoroughly investigate OOS results to identify root causes and ensure product quality.

Uploaded by

Ira Nurjannah
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© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
2K views

Microbiology Out of Specification (OOS) Investigation and Report Form

This 3-page document is a form used to report microbiology out-of-specification (OOS) test results. It includes sections to document the product and test details, evaluate the initial test and laboratory testing process, determine if the initial result is valid, and outline any retesting protocols. The form requires documentation and approval of test deviations, investigation findings, retest methods and results. It aims to thoroughly investigate OOS results to identify root causes and ensure product quality.

Uploaded by

Ira Nurjannah
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Form 690

Issue date:
Microbiology Out of Specification (OOS)
Investigation and Report Form
(Ref. MICLAB 110)
Phase 1

Out of Specification Result Out of Limits Result


(Action Level Excursions)
 (Alert Limit Excursions)

SECTION A – Product or Sample Details


Unique
Form Initiated by:
Identifier
Product
DR Number
Description
Batch Production
Product Code
Number (BPN)
Limits/
Original Test Result
Specification
Micro Manager Notified Yes  No  By who?
Initial and Date

SECTION B – Evaluation of Laboratory Testing


Control Method reference
Test Type (tick) SOP Reference
(if applicable)
Non-Sterile Testing  MICLAB 075
Water  MICLAB 055
Sterility Testing  MICLAB 060
KCA  MICLAB 085
Endotoxin
GEL  MICLAB 080
Other ……………………….. 
Name of Technician who Training records
performed the test complete
Yes  No 
Date Test
Date Sampled
performed
Was test conducted in If No, comment:
accordance with SOP & Yes  No 
Control method
Media/Reagents Used Lot Number Expiry Date Passed QC Checks
Yes  No 
Yes  No 
Yes  No 
Yes  No 
Yes  No 
Yes  No 

File Location: Date Printed: Page 1 of 3


Form 690
Issue date:
Microbiology Out of Specification (OOS)
Investigation and Report Form
(Ref. MICLAB 110)
PART B – Evaluation of Laboratory Testing (continued)
Equipment Used Calibration Due Date Temperature Trends in range
Yes  No  N/A 
Yes  No  N/A 
Yes  No  N/A 
Yes  No  N/A 
Yes  No  N/A 
Yes  No  N/A 
Test result record Comments:
Attached?
Yes  No 

Are Calculations Verified Comments:


and correct?
Yes  No 

Negative Controls Comments:


passed?
Yes  No 
Other tests from same Comments:
test session within Yes  No 
limits?
Comments:
Other Sources of Error?
Technician observations Yes  No 
during testing?
Brief Description of the
Investigation Findings to
date.

If No, is re-testing
required
Yes  No  N/A 
Is initial Result Valid? If Yes, is confirmatory or
(ie has root cause been Yes  No  investigational testing Yes  No  N/A 
identified) required?
If Yes, DR raised &
recorded in Section A
Yes 
Initials & Date
Note : If any of the above questions were answered NO, an evaluation of the validity of the test needs to be
conducted by the Micro Manager.

Print Sign Date

Approved By:
Micro Manager
NOTE: Refer to MICLAB 110 for appropriate Retest Procedures.

File Location: Date Printed: Page 2 of 3


Form 690
Issue date:
Microbiology Out of Specification (OOS)
Investigation and Report Form
(Ref. MICLAB 110)

Phase 2

PART C – Retest Protocol


Retest testing of Original Sample(s) Yes  No  N/A 
Confirmatory Testing of Original or retention Sample(s) for
Yes  No  N/A 
investigational purposes
Retest of Retain samples Yes  No  N/A 
Retest of Both Original and retain sample Yes  No  N/A 
Number of Replicates to be Tested
Test Method
Limits for Retest

Retesting Conducted by
Print Sign and Date
Please document the purpose of additional testing as detailed above.

Retest Protocol Print Sign Date


Approved By:
Micro Manager

PART C – Retest Protocol (continued) - Retest Results


Document result of Retesting in this section. Please attach hardcopy of raw data.

Print Sign Date


Approved By:
Micro Manager

File Location: Date Printed: Page 3 of 3

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