Samples Management System in the Microbiology Department

Best Practices for Sample Management in Microbiology
1.0 Objective
1.1 To lay down the procedure for the samples management system in the microbiology department from production and R&D.

2.0 Scope
2.1 This SOP is applicable to all raw materials, excipients, finished drug products, stability, formulation samples, in-process samples, and miscellaneous samples of the production and R&D centers.

3.0 Responsibilities
3.1 Microbiology personnel shall be responsible for managing the samples in the microbiology department.

4.0 Accountability
4.1 The Head/designee of Microbiology shall be responsible for ensuring compliance with this SOP.

5.0 Procedure
5.1 Upon receipt of the samples from production OR R&D Centre, allot an analytical report (AR) number and record the sample details in the sample inward register as per Annexure-01 (Sample Inward Register for Microbiology Department).

5.2 For samples received from Quality Control (QC), use the same AR number as generated in QC (e.g., raw materials, excipients, finished drug products, stability, and in-process samples).

5.3 If stability samples are received from QC, record the stability window completion date in the sample inward register.

5.4 For samples from R&D, register the samples using the same AR number as generated by the respective departments.

5.5 For samples received directly at the microbiology lab without any AR number, assign a microbiological AR number in the sample inward register.

5.6 AR Numbering Procedure for Production
5.6.1 AR numbers will consist of 12 characters (alphabetical and numerical).

The first three characters: “ARN” (Analytical Report Number).
The fourth and fifth characters: Department code (e.g., MB for Microbiology).
The sixth and seventh characters:The last two digits of the year (e.g., 24 for 2024).
The last five characters: A serial number starting from 00001.
Example: ARNMB2400001.
5.7 AR Numbering Procedure for Research centre
5.7.1 AR numbers will consist of 15 characters.

The first three characters: “ARN” (Analytical Report Number).
The fourth to sixth characters: “R&D” (Research centre).
The seventh and eighth characters: Department code (e.g., MB for Microbiology).
The ninth and tenth characters: The last two digits of the year (e.g., 24 for 2024).
The last five characters: A serial number starting from 00001.
Example: ARNR&DMB2400001.
5.8 After recording the sample details, store the samples in the designated racks.

5.9 Before analysis, retrieve the samples from the designated racks.

5.10 After completing the analysis, update the status column in the register.

5.11 Provide the analytical data sheet to QC personnel, who will prepare the final Certificate of Analysis.

5.12 If required, microbiologists shall prepare a microbial analysis report as per Annexure-02.

5.13 Dispose of leftover samples as per their respective SOPs.

6.0 Abbreviations
6.1 SOP: Standard Operating Procedure

7.0 References
7.1 SOP: Handling and disposal of laboratory waste materials and samples.

https://modrenmicrobiology.site/decontamination-and-disposal-of-used-media-microbiology-lab/

8.0 Annexures
8.1 Annexure-01: Sample inward register for microbiology department.

Inward Register for Microbiology Samples Receiving

8.2 Annexure-02: Microbial analysis report.

Microbiology Report for Product