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.
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.
- 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
REVISION HISTORY
Nil
0 Comments