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DEPARTMENT QC -MICROBIOLOGY
PRODUCT NAME
EFFECTIVE DATE
CHANGE HISTORY
TABLE OF CONTENTS
2.0 Objective 3
3.0 Scope 3
10.0 Appendix 6
Signing of this approval page of protocol indicates agreement with the method validation
approach described in this document. If any modification in the method validation
approach becomes necessary, a revision through change control shall be prepared,
checked and approved. This protocol cannot be executed until approved by following
personnel.
Prepared by
Quality Control
Microbiology
Reviewed by
Quality Control
Microbiology
Approved by
Quality Assurance
Authorised by
HOD - QA
Protocol No.
2.0 OBJECTIVE:
The protocol is designed so as to validate that any Bacteriostatic and Fungistatic activity
inherent in the products to be tested does not adversely affect the reliability of the test
and the test procedure to be followed is suitable for testing the products as per the
pharmacoepial methods.
3.0 SCOPE
This protocol is applicable to sterile raw material and finished products, which are tested
for sterility.
The purpose of this protocol is to ensure that any Bacteriostatic and fungistatic activity
inherent in the Product does not adversely affects the reliability of the test procedure.
5.2 Identification of Executors: All the identified executors involved with this Protocol are
to Record Name, Designation, Signature and Date.
6.0 TEST PROCEDURES
6.4.1.2 Finally rinse the membrane with the third 100 ml 0.1 % sterile peptone water
inoculated with 10 – 100 cells / ml of any culture listed above.
6.4.1.3 Repeat the above exercise with all the other organisms.
6.4.1.4 Inoculate the membrane into medium.
S.No. Medium Organisms Strain Number
Staphylococcus aureus
01 Fluid Thioglycollate Pseudomonas aeruginosa
Clostridium sporogenes
Bacillus subtilis
Soyabean Casein
02 Candida albicans
Digest
Aspergillus niger
Prepare the summary report in the annexure –2 and submit this for review, approval and
authorization to Validation Core Team.
10.0 APPENDIX
10.1 Abbreviations and definitions
Abbreviation Definitions
10.2 References.
10.3 Annexure
10.3.1.1 Annexure – 1 (Recording Of Observations For Validation).
10.3.1.2 Annexure – 2 (Sterility Test Validation Report).