HANDLING OF “FINISHED PRODUCT SAMPLES FOR MICROBIOLOGY ANALYSIS”

1.0 OBJECTIVE
To lay down a procedure for handling of “ Finished product Samples for Microbiology Analysis .
2.0 SCOPE
This SOP is applicable to Quality Control Department (Microbiology lab.)
3.0 RESPONSIBILITY
Microbiologist / QC Executive
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 Formulations
5.1.1 The Microbiologist shall receive the samples along with the sample request and he shall ensure intactness of the samples by visual checking of the seal.
5.1.2 The entries of the sample shall be made in the respective register by the microbiologist
5.1.3 Samples shall be kept in the tray labeled as ‘Under Test ’ till those are taken for analysis.
5.1.4 The samples shall be handled carefully to avoid cross contamination and microbial contamination.
5.1.5 When the samples shall be taken for the analysis by the Microbiologist, the relevant details and shall be mentioned in the respective registers.
5.1.6 The excess samples shall be destroyed as after completion of analysis and reporting.
5.1.7 The samples for destruction shall be kept in a container/cupboard labeled as ‘Samples for Destruction’ and shall be destroyed as mentioned below :
5.1.7.1 Tablets, capsules, and powder shall be removed from their respective pack.
5.1.7.2 Collected material shall be treated in the following manner :
1. Take water in a bucket , sufficient to make a slurry with the above sample.
2. Handover the above slurry to ETP department for disposal.
3. Packing material shall be destroyed by tearing off into small pieces.
5.1.8 No samples shall remain ‘Under Test’ for more than 5 days. Any sample found pending analysis for more than 5 days shall be investigated for delay in analysis and documented.