Sop on Non-conforming Results in Total Microbial Count in Water Samples

1.0 OBJECTIVE: 1.1 To lay down the procedure for the Corrective and Prevention Action for non-conforming results
in total microbial count in water samples

2.0 SCOPE: 2.1 This procedure is applicable to the utility department and all the production department

3.0 RESPONSIBILITY

3.1 Microbiologist
3.2 Head – Microbiology
3.3 Head – Production Block
3.4 Head Engineering and Utility

4.0 ACCOUNTABILITY

4.1 Head-Quality Assurance.

5.0 PROCEDURE

5.1 On observation of out-of-limit results in Total Microbial Count in water samples collected from water generation and distribution systems, the microbiologist shall inform the Head of Microbiology.
5.2 Head Microbiology shall check the corresponding negative control. If negative control shows microbial growth, the investigation shall be carried out for the reason for the failure of the negative control test and all test results shall be invalidated.
5.3 If negative control shows no microbial growth, Head Microbiology shall initiate the CORRECTIVE AND PREVENTIVE ACTION REQUEST (CPAR)FORM as per Annexure – I and shall record the initiation in a log given in Annexure II
5.4 Head Microbiology shall initiate the identification of microbial colonies to assess the source of the contamination.
5.5 The serial number of the CPAR form shall be generated from the log and shall be written as follows
WATM/ block code (e.g. A, B, etc) / last two digits of the year/ serial number starting from 001
Example: WATM/B/03/001 The number indicates the First nonconforming result in the microbial limit test in a water sample collected from the water system of Production Block B in the year 2003
5.6 Head-Microbiology shall categorize the failure as critical, major & minor as per Appendix-I.
5.7 Head microbiology shall send the CPAR form to the Head QA after writing the failure results, history of any failure in the same system, and criticality of the failure.
5.8 Head QA shall evaluate the failure and shall write the immediate action required as per Appendix 1.
5.9 Head QA shall form the investigation team consisting of one microbiologist, one production, one Engineering and Utility, and one QA personnel and shall write the name of the investigation team in CPAR form.
5.10 CPAR form shall be sent to Head Production / Head Engineering and Utility to take immediate action as written in the CPAR form.
5.11 Investigation team shall carry out the investigation and shall prepare the report as per Annexure – III.
5.12 Investigation report along with CPAR form after writing immediate action and investigation summary shall be given to Head QA.
5.13 If an investigation shows an error in the water system following will be proceedings:
5.14 Head QA along with Head operation shall decide the corrective and /or preventive action to take to prevent the recurrence of failure.
5.15 Recommended corrective and preventive action shall be written in the CPAR form and shall be sent to Head Production to take corrective and/or preventive actions
5.16 Sampling shall be done from all the user points for one to two weeks after taking corrective action.
5.17 The results of water samples collected after taking corrective and/or preventive action, shall be evaluated for the effect of the action taken.
5.18 On getting satisfactory results in water monitoring results, Head QA shall close the CPAR form.
5.19 If an investigation shows no error in the water system, the following will be the proceeding:
5.20 No preventive action shall be taken for an inconclusive minor and major failure.
5.21 In case of inconclusive critical failure, the frequency of sanitization of the complete water system shall be increased.
5.22 Sampling shall be done from all the user points for one to two weeks
5.22.1 On getting satisfactory results in resamples, Head QA shall close the CPAR form.
5.23 The release of the Oral drug Product batches, which had used the water failing in microbial action limit, shall be held till the completion of the investigation and shall be rejected in case the investigation ends inconclusive or investigation results indicate that microbial quality of the product is affected

6.0 ABBREVIATIONS

6.1 CCR-Change Control Request
6.2 QA-Quality Assurance

7.0 ANNEXURE

7.1 Annexure-I-Corrective and Preventive action request form
7.2 Annexure-II-Initiation Log
7.3 Annexure-III-Investigation report 7.4 Annexure- IV- Request logs