Sterility Test Failure Investigation Report




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:

                                                                        

No comments:

Post a Comment