SOP for Determination Microbial Contamination in Raw Materials and Finished Products

1.0 OBJECTIVE

To lay down the procedure for the microbial limit test for raw materials and finished products.

2.0 SCOPE

This SOP shall be applicable to the Quality Control Dept.

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head Quality Control Department.

5.0 PROCEDURE

5.1 Sampling and Analysis

5.1.1 Raw material samples having the biological origin as mentioned in Pharmacopoeia for microbiological testing shall be sampled as per the SOP for Sampling of Raw Materials and should be transferred to the Microbiology department.
5.1.2 Receive the Finished Product samples to be analyzed in the Microbiology Department.
5.1.3 Enter the sample details in the MLT inward register.
5.1.4 Prepare the required media as per the SOP for Preparation of Microbial Culture media.
5.1.5 Transfer the samples to be analyzed, sterilized media flasks, tubes and glassware into the pass box.
5.1.6 Enter and transfer the samples, sterilized media flasks and tubes into the microbiological testing area as per the procedure is given in the SOP for Entry and Exit procedure to Microbiology testing area.
5.1.7 Analysis of Total Microbial Count and Specific pathogens shall be carried out as per SOP.
5.1.8 Report the results in the format.

5.2 Frequency of Testing

5.2.1 For Raw material: All the raw materials having biological origin shall be tested as per the Specifications.

5.2.2 For Finished product

5.2.2.1 Domestic Market

Liquid orals: Initial and Final Sample from the first batch of every month for all products.
Solid orals: First batch of all products every month.

5.2.2.2 Export Market

Liquid and Solid orals: All export batches manufactured.

6.0 ABBREVIATIONS

6.1 AHU: Air Handling Unit
6.2 SOP: Standard Operating Procedure
6.3 QC: Quality Control
6.4 Dept.: Department

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