SOP for Preparation of Bench Reagents : Pharmaceutical Guidelines

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SOP for Preparation of Bench Reagents

Standard operating procedure for preparation, identification and information of reagents used during analysis of Raw Materials In-process Samples and Finished Products.

1.0 OBJECTIVE

To have a clear identification and information of the reagents those are used for analysis.

2.0 SCOPE

This procedure is applicable for the reagents, which are to be used during analysis of raw materials, in process samples and finished product.

3.0 RESPONSIBILITY

3.1 Doing : Technical Assistant
3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Prepare the required reagent as per the respective pharmacopoeia.
5.2 Fill the prepared reagent in clean dried reagent bottle.
5.3 Label the bottle appropriately -
Label - I                
Label - II
Name of reagent  :      
Date  of preparation :
Strength if any      :     
Strength     :
Method as per     :     
Sign           :
Solvent used        :      
Use before :
Ref. No.              :       
Checked By :
5.4 Assign three months expiry for all the bench reagents except if specified in the individual reagent preparation procedure.
5.5 Before using any reagent, check for the expiry date and clarity of solution. If found hazy destroy the same and prepare freshly.
5.6 Record the given detail shown in the annexure.
5.7 Assign Ref. No. to each reagent as follows.
  1. For limit test solution starting from -L – (01) 
  2. For Primary colour solution starting from –P-(01)
  3. For Indicator starting from - I-(01)
  4. For Table reagent starting from – TR-(1)
5.8 Assign Ref. No. to each reagent for Bulk drug API Q.C laboratory as follows.
  1. For limit test solution starting from -AL – (01) 
  2. For Primary colour solution starting from –AP-(01)
  3. For Indicator starting form - AI-(01)
  4. For Table reagent starting from – ATR-(1)
5.9 Assign Ref. No. to each reagent for Microbiology laboratory as follows.
  1. For Table reagent starting from MTR-(1)
  2. For Indicator starting from –MI-(01)
Related: Determination of Shelf Life of Solutions in Laboratory

6.0 ABBREVIATIONS

6.1 Ref. No. = Reference number
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