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SOP for Handling of Sample for Analysis

OBJECTIVE
To lay down a procedure for Handling of Samples for Analysis of Raw Materials / Finished Products.

RESPONSIBILITY
Quality Control Officer.

ACCOUNTABILITY
Quality Control Manager.

PROCEDURE

Raw Materials
  1. The Quality Control Officer shall receive the samples along with the GRN and ‘sampler’s check list.
  2. The samples shall be kept in the tray labeled ‘Under Test Raw Material, till those are allocated for analysis.
  3. The samples shall be handled carefully to avoid cross contamination.
  4. The samples shall be allocated for analysis by Quality Control Manager and relevant details shall be mentioned in the register.
  5. The excess samples shall be destroyed after completion of analysis.
  6. The samples for destruction shall be kept in a container labeled as “samples for destruction” and shall be destroyed as mentioned below,
  7. Raw material shall be removed from their container.
  8. The container shall be destroyed by breaking (in case of glass), by cutting (in case of plastic).
  9. Collected material shall be destroyed by putting the material in water , but the cephalosporin materials shall be destroyed by putting the material in 2% w/v solution of sodium hydroxide.
  10. Then all the collected material closed properly and send to the burning pit.

Finished Products
  1. The Quality Control Officer shall receive the samples along with the sample request form and he shall ensure intactness of the samples by visual checking.
  2. The entries of the samples shall be made in the respective register by the Quality Control Officer.
  3. Sample shall be kept in the tray labeled as ‘Under Test formulation till those are allocated for analysis.
  4. The samples shall be handled carefully to avoid cross contamination.
  5. The samples shall be allocated for the analysis by the Quality Control Manager. The relevant details of allocation and green sheet number shall be mentioned in the respective registers.
  6. The excess samples shall be destroyed after completion of analysis .
  7. The samples for destruction shall be kept in a container labeled as ‘Samples for destruction and shall be destroyed as mentioned below.
  8. Tablets, capsules, dry syrups and powder of vials shall be removed from their respective pack.
  9. Packaging material shall be destroyed by burning at burning pit and product shall be destroyed by burning at burning pit after breaking.
  • All Finished Products / Raw Material Samples of Cephalosporin group of products shall be disposed off after treating with 2% w/v Sodium Hydroxide solution.
  • No samples shall Under Test for more than 60 days. Any sample found pending for analysis for more than 60 days shall be investigated for delay in analysis & documented.

ABBREVIATIONS
SOP = Standard Operating Procedure
GRN = Goods Receipt Note
W/v = Weight by Volume

ANNEXURES
Nil

REVISION HISTORY
Nil

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