1.0 OBJECTIVE:To lay down the procedure for preservation of Control samples of Active ingredients.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 Control samples of all active ingredients used in drug products shall be retained in sufficient quantity.
5.2 A label should be pasted bearing all the relevant details like Name of the sample, batch number, supplier, mfg. date, expiry date etc.
5.3 Reserved Samples of all active ingredients shall be stored in Chemical Stores of Laboratory.
5.4 Control Samples of active ingredient shall be sufficient enough for at least 2 complete analysis.
5.5 Control Samples of active ingredients shall be retained one year after expiry of the last batch/lot of the product in which it is used.
5.6 Control Samples of active ingredients shall be destroyed as per SOP.
5.7 Lot No./Batch No. of drug products in which that particular active ingredient is used shall be made available from BMR.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
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