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REVISION SUMMARY
Version
Date Revised Reason for Revision
Number
GTP 031 - 00 17/05/2000 First Issue
GTP 031 - 01 05/09/2001 Second Issue
GTP 031 - 02 01/07/2002 Third Issue
GTP 031 - 03 01/01/2003 Fourth Issue
GTP 120 - 04 01/05/2003 Renumbering of GTP and Format Changed, Method
Enhanced
GTP 120 - 05 01/10/2003 Incorporation of investigation for failure SOP
GTP 120 - 06 10/01/2004 The Word USP is removed from the topic as this procedure is
common for both USP and EUROPEAN
PHARMACOPOEIA.
GTP 120 - 07 04/01/2005 The format of the GTP is changed as per SOP QA 030-00 and
the procedure is revised.
1.0 PURPOSE
1.1 To lay down the procedure for performing the sterility testing of sterile finished goods and
sterile raw materials.
2.0 APPARATUS
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GENERAL TEST PROCEDURE (GTP) Page 2 of 8
3.0 REAGENTS
3.1 Sterile Fluid Thioglycollate Medium
3.2 Sterile Soyabean Caesin Digest Medium.
3.3 0.1% Peptone.
3.4 Beta lactamase.
4.0 PROCEDURE
4.1 ARTICLES TO BE TESTED.
Minimum Number of Articles to be tested in Relation to the Number of Articles in the Batch are
described in table 1
Table 1
Number of Articles in the Batch Number of Articles to be Tested
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For Injections
More than 500 articles 2 % or 20 article which ever is less.
For Antibiotic Solids Bulk and Blend Products
Aseptically remove a sufficient quantity of solids from the container mix to obtain a
composite sample not less than 10 g of solids.
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GENERAL TEST PROCEDURE (GTP) Page 4 of 8
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number.
4.8.12 If any unforeseen observations e.g., sneezing, coughing, power failure or
the membrane fell on the LAF bench etc. are noticed during the
performance of sterility test, abandon the testing and declare all the tests
performed in that session as INVALID. Inform your Supervisor
immediately about the incident.
4.8.13 If the Temperature or differential pressure are not as per the acceptance
criteria inform the maintenance department to take necessary action and
after it is resumed go for sterility testing.
4.8.14 Avoid excessive aeration of FTGM.
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GENERAL TEST PROCEDURE (GTP) Page 8 of 8
5.0 REFERENCE
5.1 USP 27
5.2 EUROPEAN PHARMACOPOEIA-2005.
END OF DOCUMENT
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