SOP FOR PREPARATION AND STORAGE OF GENERAL SOLUTIONS

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1.0) OBJECTIVE:

To lay down a standard procedure for preparation, storage and use of general solution and as per the Pharmacopoeial and in-house standards in Quality Control Department.

2.0) SCOPE:

This SOP is applicable for preparation, storage and use of general solution and indicator used in Quality   Control Department at

3.0) RESPONSIBILITY:

Officers / Executive – Quality Control shall be responsible for complies of this SOP

4.0) ACCOUNTABILITY:

Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.

5.0    ATTACHMENTS:

Preparation of general solutions                              Attachment-I

Label of general solutions                                       Attachment-II

List of code number of general solution                  Attachment-III

6.0)    PROCEDURE:

  • PREPARATION AND STORAGE:
    • Before preparation of the general solution container of the general solution shall be checked for its cleanliness.
    • Prepare the general solution as per procedure mentioned in IP, BP, USP or as per individual GTP.
    • Make the entry of the weight of the reagent taken, diluted to volume, prepared on / by etc. in the “test solution preparation record” Attachment-I.
    • Code number of general solution shall be sourced from Attachment III.
    • Use amber colored bottles for the photosensitive solutions / reagents.
    • Label the bottle for general solution and Indicator solution with details as name and Strength of solution, Batch No. , Prepared on, Use before, signature of the person who prepared it and checked it.
    • The reagents shall be stored at room temperature or in refrigerator as per the indication given in the pharmacopoeia or its GTP.
  • VALIDITY:

6.2.1 Validity of the general solution is 1 month and from the date of preparation. While using the reagents, ensure that there is no precipitation, haziness or any evidence of deterioration.

6.2.2 If there is any precipitation or haziness in the reagent discard it immediately and prepare a fresh reagent as per procedure.

6.2.3 Discard the reagent after its shelf life is over. It shall be discarded by draining under running tap.

  • REFERENCES:

In-house

  • ABBREVIATIONS:

SOP: Standard Operating Procedure

QC: Quality Control

GTP: General Test Procedure

IP: Indian Pharmacopoeia

EP: European Pharmacopoeia

BP: British Pharmacopoeia

QA: Quality Assurance

  • DISTRIBUTION LIST:

         Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION:

Version No. Date of Revision Reason for Revision
Title : PREPARATION OF GENERAL SOLUTION

 
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SOPs