SOP for Preparation of Reagents and Indicators

1. OBJECTIVE:

To lay down a procedure for preparation of reagents and indicators.

• SCOPE:

This procedure is applicable for procedure for preparation of reagents and indicators.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

• PROCEDURE:
  • Preparation of reagent solution and indicator:
  • Prepare the reagent solution and indicator as per respective pharmacopeias.
  • Use freshly prepared purified water for the preparation of reagent solution and indicator.
  • Use AR grade or LR grade of reagent for the preparation of reagent solution and indicator.
  • Record all the details of preparation as per annexure.
  • Before sign on the record, authorized person ensure the preparation of reagent solution and indicator as per standard procedure given in respective pharmacopeias.
  • Assign the ID No. of reagent solution or indicator.
  • Storage of reagent solution and indicator:
  • Filter reagent solution and indicator through filter paper and store the solution in clean and dry glass bottle.
  • Store the light sensitive and coloured reagent solution or indicator in amber coloured glass bottle.
  • Prepared reagent solution and indicators shall be used within three months from the date of preparation or as mentioned in respective pharmacopoeia.
  • If any abnormal observations like precipitate or opalescence found during storage, within the validity period, the same shall be destroyed immediately and record the details.
  • Store reagent solution and indicator at room temperature or as specified in the respective pharmacopoeia.
  • Labeling of reagent solution or indicator:
  • Transfer the prepared reagent solution or indicator in clean and dry glass bottle.
  • Affix the label, having details of reagent solution or indicator as per annexure on the bottle at the center.
  • Hold time study & Observation:
  • Perform the observation every 7^th day up to valid time.
  • During observation if any reagent fails in clarity, then discard the reagent and prepare fresh reagent.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• ATTACHMENTS:

NA

• REFERENCES:

In-House

1. ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
QC	Quality Control
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department

1. REVISION HISTORY OF CHANGE:

Sr. No.	Date	Revision Details	Revision No.
01	01/01/2020	NEW SOP	00