sop of placebo and impurity stock solutions


sop of placebo and impurity stock solutions

To lay down a procedure for Handling of Placebo And Impurity Stock Solutions.
Placebo: A placebo is an inactive drug composition or composition of drug without any Active Pharmaceuticals Ingredient.
Impurity: The unwanted chemicals that remain with active pharmaceuticals ingredients, or develop during formulation or upon aging of both API and formulation API to medicines

2.0. SCOPE:
This SOP is applicable of handling of placebo and impurity stock solutions in quality control department


Head- Quality Control


5.1 For related substance test placebo shall be used.

52 Placebo shall be provided to QC from QA during batch manufacturing.
5.3 Placebo shall be stored at room temperature with proper labeling as per detail mention in the label format in Annexure-I.
5.4 All the placebo samples shall be valid for one year only.
5.5 New Placebo samples shall be collected after one year or at every revised formulation
5.6.1 In case if a product having two or more than two API than the placebo shall be made with including all the API excluding the API for which RS is to be performed.
5.7.1 QC Officer /Executive shall prepare the stock solutions as and when required.
5.7.2 Section Head/designee shall prepare the Impurity Stock solutions and maintain the record as per Annexure-III (For qualitative test) and Annexure – IV (For Quantitative test)
5.7.3 Label of the Impurity Stock solution shall have the details as per Annexure-II.

5.7.4 After each analysis, Analyst shall attach the Impurity / Reference Standard chromatogram with Annexure-III and Annexure – IV
5.7.5 All the stock solution shall be stored at 2 to 7 ºC degree in cold chamber.
5.7.6 Stock solution consumption record shall be maintained as per Annexure-III.
5.8.1 Area of the Impurity stock solution for qualitative test shall be valid for the period till it comples the system suitability criteria as per respective STP For e.g. Resolution test etc.
5.8.2 Consumption record of Impurity stock solution used for quantification purpose shall be maintained as per


5.8.3 When new lot of impurity issued by any pharmacopoeia.
5.9 Left over sample of placebo and the stock solution shall be destroyed as per SOP

5.10.1 When any new Placebo solution is prepared, ID number shall be allotted to it.
5.10.2 Identification number of placebo solution shall be PS/PS/XX/YYY

5.10.5 List of Placebo shall be prepared as per Annexure –V
5.10.6 List of Impurity stock solution shall be prepared as per Annexure –VI


NA       Not Applicable
SOP     Standard Operating Procedure
No.     Number
QC     Quality Control
QA     Quality Assurance
STP     Standard Operating procedure


Annexure No. Title of Annexure Format No.
Annexure-I Label Format of Placebo
Annexure-II Label Format of Impurity Stock Solution
Annexure-III Impurity Stock Solution Consumption Record (For Qualitative Test)
Annexure-IV Impurity Stock Solution Consumption Record (For Quantification Of Impurity)
Annexure-V List of Placebo
Annexure-VI List of Impurity stock Solutions



Quality Control Department
Quality Assurance Department

In   House


Revision No. Change Control No. Details of Changes Reason of Changes Effective Date Done By
Not Applicable Not Applicable New SOP






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