Company Name	Quality Assurance Department
Sterility Test Failure Investigation Report	Issue Date :-  Revision No:-

Product Name			Batch   No.			Batch Size
Mfg Date		Expiry Date				Test Date
Date of Filling				Date of Autoclave

MICROBIAL EVALUATION OF RAW MATERIAL

CFU/ gm Of Raw Material

NMT

Endotoxin Test Result

NMT

Limit: - Bacteria (B), Mold (M)      

Microbial Count Limits Of Different Areas           Ref. SOP-07-009 & 023
High Risk	Lowe Risk
Action Level                                  B               M	Alert Level                        B                                  M
LAFW                                            03             Nil	02                                 Nil
Filling Room                                  04             Nil	03                                 Nil
Buffer  and  Solution room            06             Nil	04                                 Nil
Changing Room                             15             01	10                                  01

Area Grade	Maximum Permitted No. of Particles / m3       Ref. SOP
	At Rest	In Operation
	0.5 mm	0.5 mm
CLASS A	3500	3500
CLASS B	3500	350,000
CLASS C	350,000	3500,000

BATCH HISTORY REVIEW     

Product Name and Batch No. =

WASHING/ STERILIZATION OF VIALS/ AMPOULES:

Washing Date		Any Problem Occurred During Washing
Vial/ Ampoule Sterilization Date		Sterilization Temperature
Sterilization Time		Any Problem Occurred During Sterilization

FILLING:

Date of filling start		Time of filling start
Date of filling End		Time of filling End
Filling Operator		Filter Integrity Test Performed or not
Any Problem Occurred During Filling		Power Supply Problem Occurred or not During Filling

TERMINAL STERILIZATION:                                                                                 

Terminal Sterilization Date		Sterilization Temperature
Sterilization Time		No. of Autoclave Cycles
No. of Trays Per Cycle		No. of Amp/Vials Per Tray
Chemical/ Biological Indicators Used		Operator Name

Any Other Information:

___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

AREA RESULTS DURING FILLING OF BATCH

Test Performed	Date
	CLASS A	CLASS B	CLASS C
Air Sampling
Plates Exposed
Particle Count
Gown swab
Hand Test

AREA RESULTS DURING PREVIOUS AND NEXT BATCHES

Previous Batches

Next Batches

Test Performed

Date Batch #

Date Batch #

Date Batch #

Date Batch #

CLASS A

CLASS B

CLASS C

CLASS A

CLASS B

CLASS C

CLASS A

CLASS B

CLASS C

CLASS A

CLASS B

CLASS C

Air Sampling

Plates Exposed

Particle Count

Gown swab

Hand Test

Surface Swab Test

OTHER INFORMATION

Media Filling Trial Date			Media Filling Trial Results
Number Of HEPA Filters In Filling Room		Number Of HEPA Filters In Solution Preparation Room
Date Of DOP Test Of HEPA Filters			Results Of Air Velocity Of Laminar Flow Hood

Sterility Test Date

Method Of Sterility Testing Ref. SOP-07-014

Microbial Count of Micro Lab

CLASS A

CLASS B

Plates exposed during sterility testing or not

Positive Control

Negative Control

Log Of Sterilization Cycle Completed Or Not

Repeat Sterility Test Date

Method Of Sterility Testing

Microbial Count of Micro Lab

CLASS A

CLASS B

Plates exposed during sterility testing or not

Positive Control

Negative Control

Log Of Sterilization Cycle Completed Or Not

DATA OF STERILITY TEST PERFORMED

GROWTH SUPPORT TEST        REF. SOP-07-025

Sr#	Date	Media Name	Media lot#	Strain used	Ref#
01
02

ISOLATION OF STERILITY FAILURE CAUSING ORGANISM       REF. SOP-

Media	Results	Positive Control	Negative Control
Sabouraud Agar
Nutrient Agar
Mannitol Salt Agar
MacConkey Agar

IDENTIFICATION OF STERILITY FAILURE CAUSING ORGANISM

Microscopic Identification of Organism on the Basis of Shape

SUPPOSED SOURCE OF STERILITY FAILURE CAUSING ORGANISM

Air

Water

Human

REASON OF SUPPOSED SOURCE OF CONTAMINATION:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

CORRECTIVE ACTION TAKEN:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

PREVENTIVE ACTIONS RECOMMENDED:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

INVESTIGATED BY:

REMARKS BY QUALITY ASSURANCE MANAGER (IF ANY): ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

     

QA manager:                                                                                                                           Date:

REMARKS BY DIRECTOR (IF ANY): ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Director:                                                                                                                                 Date: