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
This SOP is applicable of handling of placebo and impurity stock solutions in quality control department
Head- Quality Control
5.0 PROCEDURE FOR PREPARATION OF PLACEBO SOLUTIONS
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 API INCLUDING AND EXCLUDING OF PLACEBO FOR MULTIPLE CONTENTS OF RS
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 PROCEDURE FOR PREPARATION OF IMPURITY STOCK SOLUTIONS
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 CRITERIA FOR USE BEFORE DATE OF IMPURITY STOCK SOLUTIONS
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 IDENTIFICATION NUMBERING SYSTEM FOR IMPURITY SOLUTION AND PLACEBO SOLUTION
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
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
10.0 REVISION HISTORY:
|Revision No.||Change Control No.||Details of Changes||Reason of Changes||Effective Date||Done By|
|Not Applicable||Not Applicable||New SOP|