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.
This SOP is applicable for preparation, storage and use of general solution and indicator used in Quality Control Department at
Officers / Executive – Quality Control shall be responsible for complies of this SOP
Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
Preparation of general solutions Attachment-I
Label of general solutions Attachment-II
List of code number of general solution Attachment-III
- 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.
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.
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:
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