1.0 OBJECTIVE:To lay down the procedure for Microbial limit test for raw materials and finished products.
2.0 SCOPE:This SOP shall be applicable to the Quality Control Dept.
4.0 ACCOUNTABILITY:Head Quality Control Department.
5.1 Sampling and Analysis :5.1.1 Raw material samples having 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 in to the pass box.
5.1.6 Enter and transfer the samples, sterilized media flasks and tubes in to the microbiological testing area as per the procedure 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:
184.108.40.206 Domestic Market:
Liquid orals : Initial and Final Sample from First batch of every month for all products.
Solid orals : First batch of all products in every month
220.127.116.11 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
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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