HANDLING OF “SAMPLES FOR ANALYSIS”

1.0 OBJECTIVE
To lay down a procedure for handling of “ Samples for Analysis ” of formulation / raw materials.
2.0 SCOPE
This SOP is applicable to Quality Control Department, Formulations Units
3.0 RESPONSIBILITY
Quality Control Chemist / Executive
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 Formulations
5.1.1 The QC chemist shall receive the samples along with the sample request form 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 QC chemist
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.
5.1.5 When the samples shall be taken for the analysis by the QC Chemist, 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 30 days. Any sample found pending analysis for more than 30 days shall be investigated for delay in analysis and documented.
5.2 Raw Material
5.2.1 The QC Chemist shall receive the samples.
5.2.2 The samples shall be kept in the tray labeled ‘UNDER TEST’, till those are taken for analysis.
5.2.3 The samples shall be handled carefully to avoid cross contamination and the same time control sample should be taken from sample collected during sampling.
5.2.4 When the samples shall be taken by QC Chemist for Analysis, relevant details shall be mentioned in the register.
5.2.5 The excess samples shall be destroyed after completion of analysis and reporting.
5.2.6 The samples for destruction shall be kept in a container labeled as “Samples for Destruction” and shall be destroyed as mentioned below :
5.2.7 Raw Material shall be removed from their container.
5.2.7.1 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. The container shall be destroyed by breaking (in case of glass), by cutting (in case of plastic).
5.2 PACKING MATERIAL
5.3.1 The QC Chemist shall receive the samples.
5.3.2 The samples shall be kept in the tray labeled “UNDER TEST”, till those are taken for analysis.
5.3.3 When the samples shall be taken by QC Chemist for analysis, relevant details shall be mentioned in the register.
5.3.4 The excess samples shall be destroyed after completion of analysis and reporting.
5.3.5 The samples for destruction shall be kept in a container labled as “Samples for Destruction” and shall be destroyed as mentioned below:
5.3.6 Collected material shall be treated in the following manner.
1. In case of labels, Cartons and aluminium foil tear it off and send it to scrap for shedder.
2. For AQL testing send the material back to Stores.
5.4 A record of samples disposed should be maintained.
5.5 No Samples shall remain under test more than 30 days.
5.6 Any sample found pending analysis for more than 30 days shall be investigated for delay in analysis and documented.