Review of trends in Environmental monitoring and water

1.0 OBJECTIVE

1.1 To define a procedure, which provides a guideline for review of the data, generated during routine monitoring of the systems.         

2.0 SCOPE

2.1 This procedure is applicable for the trends of Environmental monitoring data and Water system Monitoring data

3.0 RESPONSIBILITY

3.1 Microbiologist

3.2 QC- Chemist

3.3 IPQA - Chemist 

4.0 ACCOUNTABILITY

4.1 In Charge – Quality Assurance

5.0 PROCEDURE

Tends shall be prepared using data generated during routine monitoring of the respective systems by graphical presentation, to check whether the process is drifted from its operating range, specifications and in-house limits.

Routine data shall be pooled into a format which shall include but not limited to Monitoring date, specific sampling locations, sampling methods, CFU/ non viable count results, identification performed, Product lot information, and the current action/ alert levels.

5.1 Trends analysis shall be used to find the alert and action levels and provides “early warning” mechanism to initiate the corrective action before the product quality is adversely affected.

5.2 Alert and action levels shall be derived from and consistent with results obtained during the process. Historical data from routine monitoring shall be used in setting alert and action levels or Action levels shall be derived from the Regulatory guidelines

5.3 Review of trends shall be done on monthly basis for the following systems, but not limited to, Environmental Monitoring Data – viable and non-viable particle counts, Water system Monitoring data like microbial and chemical including TOC.

5.4 REVIEW OF ENVIRONMENTAL TRENDS

5.4.1 Excursions that exceed alert levels shall be investigated and documented and may not require corrective actions.

5.4.2 A documented review of previous results from that site shall be performed to determine if an unfavourable trend has developed. If require additional sampling shall be taken to conform.

5.4.3 Excursions exceeding the action levels, more extensive, timely and documented investigation shall be performed.

5.4.4 Excursions occur in the areas that are critical to the process (Grade A) shall require a more rigorous investigation and corrective action.

5.4.5 Trends show a gradual increase or decrease in the overall counts observed over period of time or a change in flora or counts on several plates of a particular area on a given day.

5.4.6 In case of any excursions, investigation of the following systems shall be performed HVAC, water, Gas system, Facility surfaces, personnel gowning and glove prints shall checked

5.5 WATER SYSTEM TRENDS

5.5.1 Microbial trends shall be prepared by using data generated as per the sampling plan.

5.5.1.1 Excursions or spikes even when the results are below the action levels, but with multiple excursions or even a single excursion with a significant drift from the base level shall be investigated, if require by taking more samples of that site/area and previous reports for at least one week shall be reviewed for any un favorable results.

5.5.1.2 Excursions that are exceeding the action levels shall be Investigated and corrective actions shall be initiated for microbial data as per the SOP. 

5.5.2 pH and conductivity trends

5.5.2.1 pH and Conductivity  trends shall be prepared using data generated as per the sampling plan

5.5.2.2 Spikes, excursions, which may be single or multiple, or shows continuous rise but with in the action level shall be investigated. Documented review of previous results from that site shall be performed to determine if any unfavorable results. If require additional sampling shall be taken to conform.

5.5.3 TOC

5.5.3.1 Spikes preceded and succeed by number of TOC readings are acceptable without further investigation.

5.5.3.2 Spikes indicating the potential source shall be investigated on the following lines

5.5.3.3 Source of raw water

5.5.3.4 Regeneration frequency of resin beds

5.5.3.5 Back wash and sanitation of carbon bed

5.5.3.6 Bacterial Endotoxin test levels in Water for Injection

5.5.3.7  Sanitation of Purified water and Water for Injection loop lines.

5.6 Based on the investigation report Annexure I corrective actions shall be  initiated.

6.0 ANNEXURES

6.1  Annexure -I : Investigation in case of High pH, Conductivity and TOC