Failure Investigation of Sterility

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1.0 OBJECTIVE

To lay down the procedure for investigation of sterility failure.

2.0 SCOPE

This procedure applies to the manufacturing facilities

3.0 RESPONIBILITY

Quality assurance
Head – Quality Assurance & Regulatory Affairs

4.0 PROCEDURE

As soon as initial sterility positive is observed in any batch, a note is issued to Head – Production, to stop the production campaign and no further batches are manufactured until investigations are completed.

The batch showing initial sterility positive is subjected to detailed investigation Remaining batches (preceding and succeeding) of the campaign, already manufactured are kept on HOLD until the investigation is complete.

INVESTIGATION OF STERILITY POSITIVE IS CONDUCTED BY A TEAM COMPRISING:

Head production
Head quality control
Head quality assurance
Head validation
Head QC issues an investigation report.

INVESTIGATION OF STERILITY POSITIVES

Review of negative control tubes

Review of sterilization parameters for sterility testing aids like media filtration cups. Membranes and garments etc.

Review of following records for at least 15 days prior to manufacture of suspect batch until date:
Environmental and personnel monitoring records of manufacturing are and sterility testing area
Temperature, Relative Humidity, Differential Pressure and Non-Viable Particulate Counts of manufacturing area and Testing Area.
Surface monitoring (swab) record.
Microbiological monitoring data of WFI System.
Integrity testing data of all filters including air,water and HEPA filters (both terminal and LAF units)
Characterization of the organism recovered from sterility positive tube and correlation with the organisms found in the environmental /personnel monitoring.
History of sterility positive for the products manufactured in this facility.
Organism recovered during earlier sterility /system simulation failure.

Other relevant data for the investigation, and out lined in the investigation report.

All key parameters will be kept under close control and review for a 30 day period after observation of sterility positive.

Batch Production Record of the suspect batch is reviewed to detect any Process related failures and aseptic practices.

After investigation, if no assignable cause is attributed to the sterility positive all batches manufactured in that campaign, including the batch showing sterility positive is reject.

If no assignable cause of Sterility Positive is found, the entire equipment train is cleaned, Sterilized and if required through Investigation Report, a fresh Media Run is conducted to ensure Sterility Assurance in the Manufacturing Area before restarting the new product.

During investigation of sterility positive, if it is established unambiguously that “Sterility Positive” in a batch is due to laboratory failure only, then remaining Batches of the Campaign are released subject to meeting all other test Parameters.

Only the batch showing sterility positive due to faulty aseptic technique or materials used in conducting the sterility test, is Rejected, and taken for reprocessing / rework as per the approved procedure

A detailed investigation in to sterility positive is carried out

For investigating sterility a report shall prepare.

ABBREVIATIONS

The abbreviations used in the SOP are:
SOP – Standard Operating Procedure
No. – Number
QA – Quality Assurance
QC – Quality Control
NA – Not Applicable

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