Company Name
|
Quality Assurance Department
|
|
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