UNERTL SCOPE IDENTIFICATION UPDATE

Chemicals and Reagents (Isolation Procedure for Microorganisms):.

Media (Isolation Procedure for Microorganisms) :.

Isolation Procedure for Microorganisms :.

However, the fungal isolates shall be used to verify the growth promotion ability of the media used for monitoring.

In the case of fungi obtained from monitoring, these isolates may not be identified always.

Allot the numbers of isolates as per the above procedure defined.

The identified isolates shall be preserved for a period of one year using the seed lot technique and maintain in Annexure- 2.

Verify the growth promotion ability of the media using the Isolate initially and record in Annexure- 3.

In case any of the isolates are identified as Specified Microorganisms, notify the Quality Assurance and Production department.

Evaluate the isolates, summarize the identification profile and the recommendations to the Quality Assurance through an addendum to the OOS document.

Isolate and identify the colonies if the total microbial counts exceed the action limits (Out of Specification results) in case of the finished products.

Isolates from the Non-Sterile Products (Oral Solid Dosage Forms) – (Isolation of Microorganisms):.

YY- Last Two Digits of the current year.

Allot the number of seed lots of Environment and Water isolates as below.

The identified isolates shall be preserved for a period of one year using the seed lot technique and maintain the Annexure-2.

Verify the growth promotion ability of the media using the isolates initially and record in Annexure- 3.

In case this organism is already identified (repeat isolate), then the database shall be updated accordingly, but the culture need not be preserved.

In this context, if an isolate is found morphologically different, the isolate shall be picked, and take a photograph of the colony for colony shape, elevation and Edge refer Annexure-4 (but not limited to) and identified.

Due to the physiological stress on the isolates, the organisms inherently may show up slightly different morphology.

The characterization of the predominant flora shall be useful in investigating the excursions.

Identify the predominant flora when the total microbial counts (microorganism) exceed alert and action limits in water or Environment.

UNERTL SCOPE IDENTIFICATION UPDATE

Update the database as and when a new isolate is identified.

Create a database (if required) for the cultures obtained from the water and Environment.

Isolate all the morphologically different colonies and identify them up to the genus preferably up to species level.

Isolates from Water and Environment (Isolation of Microorganisms)) :.

Colony-forming unit (CFU): Visible outcome of the growth of micro-organisms arising from single or multiple cells.Ħ.0 PROCEDURE- ISOLATION AND IDENTIFICATION OF MICROORGANISMS :.

SOP: A written authorized procedure, which gives instructions for performing operations.

Site Quality Head and Head QA shall be responsible for the approval of SOP.

Head of the Department / Designee of respective areas & QA shall be responsible for reviewing the SOP.

Officer or Executive of the Microbiology department shall be responsible for the preparation of new or revision of existing SOP.

SOP for Environmental Monitoring Program.

SOP for Aseptic Technique for Microbiological Testing.

Unertl scope identification