1.0 Objective
To clearly define the process for conducting an investigation for the failure of sterility test. This will find out whether the sample actually fails or it is an error due to test or analysis in the laboratory equipment and area malfunction and equipment malfunction in production or laboratory2.0 Scope
This procedure is applicable to OOS results of sterility test of finish product only carried out in the microbiology laboratory.3.0 Responsibility
3.1 Doing: Technical Assistant/Executive3.2 Checking: Executive/Manager
4.0 AccountAbility
Head of the Department5.0 Procedure
5.1 Definition OOS:
This term includes all suspect results that fall outside specifications on acceptance criteria established by the manufactures in official compendia in product registration dossier or any other form of legal documents.5.2 Laboratory Investigation
5.2.1 Inform to Q.C incharge immediately when OOS results occur, in laboratory notification form as per Annexure – I.5.2.2 Complete the investigation checklist and report as per Annexure - II.
5.2.3 Check negative control for no growth.
5.2.4 Identify the organisms for the positive test from the growth of sample.
5.2.5 Try to find the source of organisms in the laboratory as well as in manufacturing area.
5.2.6 If no cause is found, reject the batch.
5.2.7 If the cause is found, perform a retest on the same number of the sample.
5.2.8 If no evidence of microbial growth is found on retesting, the preparation being examined passes the test for sterility.
5.2.9 If the evidence of microbial growth is found on retest, the preparation being examined fails the test for sterility.
5.2.10 As per IP if evidence of microbial growth is found, the preparation being examined does not comply with the test for sterility.
5.2.11 Do not repeat the test unless it can be clearly shown that the test was invalid for causes unrelated to the preparation being examined.
5.2.12 The test may consider invalid only when one or more of the following conditions are fulfilled.
5.2.12.1 If microbial growth is found in the negative controls.
5.2.12.2 Data on microbial monitoring of the sterility testing facility show a fault.
5.2.12.3 A review of the testing procedure used for the test in question reveals a fault.
5.2.12.4 After identifying the microorganisms isolated from the containers showing microbial growth, the growth may be ascribed without any doubt to or the technique used in conducting the test procedure.
5.2.13 If the test is declared to be the invalid repeat with the same number of the unit as in the original test. It no evidence of microbial growth is found in the repeat test, the preparation being examined complies with the test for sterility. It microbial growth is found in the repeat test and confirmed microscopically the preparation being examined does not comply with the test for sterility.
5.2.14 Prepare laboratory investigation report with complete details as per Annexure – III and submit to QA for their approvals and further investigation if necessary.
6.0 ABBREVIATIONS :
O.O.S = Out of Specification
ANNEXURE - I
LABORATORY INVESTIGATION NOTIFICATION FORM
INVESTIGATION REPORT NO: ____________________________________Name of Product : __________________________________________
Batch No. :________________________
Batch Size : _______________________
SUMMARY OF PROBLEM : __________________________________________
___________________________________________
Microbiologist error
Report By : _____________________ Date : _____________
Checked By : _____________________ Date : _____________
|
ANNEXURE - I
LABORATORY INVESTIGATION NOTIFICATION FORM
INVESTIGATION REPORT NO: _____________________________________Name of Product : __________________________________________
Batch No. :________________________
Batch Size : _______________________
SUMMARY OF PROBLEM : __________________________________________
___________________________________________
Microbiologist error
Report By : _____________________ Date : _____________
Checked By : _____________________ Date : _____________
|
ANNEXURE - II
QUALITY CONTROL.DEPARTMENT
CHECKLIST
PAGE 1 OF 2
No.
|
Particulars
|
Yes
|
No
|
A
|
Environment
| ||
A1
|
Are the count of sterility room by settling plate test above action level?
| ||
A2
| Are the viable count of all area of sterility testing room by Rodac plate and swab above action level? | ||
A3
|
Are the count obtained in gowning and fingerprint above action level?
| ||
A4
|
Is the fumigation properly carried out?
| ||
A5
|
Are the non viable count observed within the limit?
| ||
A6
|
Are the floor cleaned with respective disinfectant and according to schedule?
| ||
A7
|
Are the LAF cleaned as per the schedule with respective disinfectant?
| ||
A8
|
Is the last DOP test carried out as per the schedule and satisfactory?
| ||
A9
|
Is the LAF in proper working condition with respect to pressure drop.?
| ||
B
|
Personnel monitoring correlation
| ||
| B1 | Correlation of environmental monitoring (lab), surface and personnel monitoring isolate with organisms observed in the sample? | ||
B2
| Co-relation of environmental monitoring (mfg.) surface and personnel monitoring isolate with the organisms observed in the sample? | ||
C
|
General
| ||
C1
|
Is the filtration assembly working, properly assembled and sterilised ?
| ||
C2
|
Is the autoclave validated or not ?
| ||
C3
|
Is UV lamp in working period ?
| ||
C4
|
Is the incubator under controlled temperature?
|
ANNEXURE - II
QUALITY CONTROL.DEPARTMENT
CHECKLIST
PAGE 2 OF 2
No
|
Particulars
|
Yes
|
No
|
C
|
General
| ||
C5
|
Were media used before expiry?
| ||
C6
|
Is there any evidence that contaminated media was used?
| ||
C7
|
Is the culture used for the control have transferred as per schedule?
| ||
C8
|
Is the culture used for the positive control has been activated by 3-4 transfer?
| ||
C9
|
Is the master culture from ATCC?
| ||
C10
|
Is the approved method used for sterility testing?
| ||
C11
|
Was the test method followed correctly?
| ||
C12
|
Is the -ve control kept or not during testing and growth found or not?
| ||
C13
|
Growth observed in –ve control tube?
| ||
C14
|
Is there any evidence that sampling done is not proper?
| ||
C15
|
Is there as similar history with the product in past?
| ||
C16
|
Have there been similar errors in the past?
| ||
C17
|
Is microbiologist trained?
| ||
C18
|
Is microbiologist enough experience?
| ||
C19
|
Has microbiologist sufficient job knowledge?
|
Report By : _____________ Date of Report : _____________ Checked By : ___________
ANNEXURE – III
LABORATORY INVESTIGATION REPORT
Page No : 1 of 2
NAME OF PRODUCT/MATERIAL : _____________________BATCH NO/AR NO : ______________
DESCRIPTION OF PROBLEM : _______________________________________________________
____________________________________________________________________________________
TEST : _______________________ TEST DATE : _______________ SOP : __________________
ANALYST : ____________________ RETEST DATE : __________________
(RESAMPLED)
Explanation : _______________________________________________________________________________
Explanation : ______________________________________________________________________________
Prepared By (Q.C) : _________________ Date : _______________
Checked By (Q.C) : _________________ Date : _______________
Approved By (Q.A) : __________________ Date : ________________
|
ANNEXURE – III
LABORATORY INVESTIGATION REPORT
Page No : 2 of 2
INVESTIGATION REPORT NO: _____________________________
ADDITIONAL INFORMATION:
Additional information required: Retest date and reasons for the retest, all participants’ names, all original and retest results, evidence for the conclusion and names of individuals responsible for the corrective action.
If other additional information is available concerning the nature of the problem, diagnostic tests to be performed, more detailed results of the investigation or suggested corrective action, explain below or attach a memo to this form.
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