SOP for Handling of Sample for Analysis

OBJECTIVE

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

RESPONSIBILITY

Quality Control Officer.

ACCOUNTABILITY

Quality Control Manager.

PROCEDURE

Raw Materials

• The Quality Control Officer shall receive the samples along with the GRN and ‘sampler’s checklist.
• The samples shall be kept in the tray labeled ‘Under Test Raw Material, till those are allocated for analysis.
• The samples shall be handled carefully to avoid cross-contamination.
• The samples shall be allocated for analysis by Quality Control Manager and relevant details shall be mentioned in the register.
• The excess samples shall be destroyed after the completion of the analysis.
• The samples for destruction shall be kept in a container labeled as “samples for destruction” and shall be destroyed as mentioned below.

• The raw material shall be removed from their container.
• The container shall be destroyed by breaking (in the case of glass), by cutting (in the case of plastic).
• 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.
• Then all the collected material is closed properly and send to the burning pit.

ALSO READ: SOP for Analyst Validation

Finished Products

• The Quality Control Officer shall receive the samples along with the sample request form and he shall ensure the intactness of the samples by visual checking.
• The entries of the samples shall be made in the respective register by the Quality Control Officer.
• A sample shall be kept in the tray labeled as ‘Under Test formulation till those are allocated for analysis.
• The samples shall be handled carefully to avoid cross-contamination.

• The samples shall be allocated for analysis by the Quality Control Manager. The relevant details of allocation and green sheet number shall be mentioned in the respective registers.
• The excess samples shall be destroyed after the completion of the analysis.
• The samples for destruction shall be kept in a container labeled as ‘Samples for destruction and shall be destroyed as mentioned below.
• Tablets, capsules, dry syrups and powder of vials shall be removed from their respective pack.
• Packaging material shall be destroyed by burning at a burning pit and the product shall be destroyed by burning at the burning pit after breaking.
• All Finished Products / Raw Material Samples of the Cephalosporin group of products shall be disposed of after treatment with 2% w/v Sodium Hydroxide solution.

ALSO READ: SOP for Sampling Plan of Raw Materials

• No samples shall be Under Test for more than 60 days. Any sample found pending for analysis for more than 60 days shall be investigated for the delay in analysis & documented.

ABBREVIATIONS

SOP = Standard Operating Procedure

GRN = Goods Receipt Note

w/v = Weight by Volume

ANNEXURES

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Retesting Schedule of Raw Material