SOP on Internal Labeling in the Quality Control Department
PURPOSE: To define procedures for Internal Labeling in the Quality Control Department.
SCOPE: This procedure is applicable for Internal Labeling in the Quality Control Department.
RESPONSIBILITY
Analyst / QC – officer / Executive – QC: To Prepare and follow SOP
Head QC: To ensure implementation of SOP.
PROCEDURE :
Internal labeling in the quality control Department should be controlled.
“MOBILE PHASE” label
The “Mobile phase” label (attachment – I) should be pasted on the container that is used for the mobile phase by the analyst.
Analyst writes the detail on the Mobile Phase Label (i.e. Name of product, Composition of mobile phase, Date of preparation of Mobile Phase, and valid up to)
The mobile phase label should be signed by the Analyst, and the label should be checked by the QC executive or above.
“RAW MATERIAL RETAINED SAMPLE” label
The “Raw Material Retained sample” label (Attachment – II) should be pasted on the container that is used for the raw material control sample.
QC person prepares the control sample of raw material as per the current respective SOP stick the label on the container and writes the detail on the Label (i.e. Name of Material, A. R. No., Batch No., quantity kept, and Date of preparation of control sample)
“Raw Material Retained sample” label should be signed by the QC person (Who prepared the retained sample), and the label should be checked by the QC executive or above.
Usage of Column
The column shall be flushed properly after the analysis is complete. A suitable column washing method shall be used, after completion of washing remove the column from the system. Put the end plugs and keep the column in the respective place.
Precautions
Avoid any jerks, or shocks to the column
For the silica column maintain the mobile phase pH between 2 to 8.
