SOP for Collection and Storage of Retained Samples of Packaging Material : Pharmaceutical Guidelines

SOP for Collection and Storage of Retained Samples of Packaging Material

Standard operating procedure to collect & storage packaging material as control sample.

1.0  OBJECTIVE

       To collect & storage packaging material as retain sample.

2.0  SCOPE

       This procedure is applicable to packaging material received as per the list.

3.0  RESPONSIBILITY

3.1  Doing      : Technical Assistant/Executive
3.2  Checking : Executive/Manager

4.0  ACCOUNTABILITY

       Head of the Department

5.0  PROCEDURE

5.1  Keep one specimen of packaging material marked with * as per list 5.5 from the quantity sampled and attached to respective Q.C. testing report. Mention the A.R.No. on packaging material at suitable place.
5.2  Keep the retain sample of packing material other than mark with * as per list 5.5 in separate box properly labelled.
5.3  Store the retain sample of packaging material for 3 years.
5.4  Destroy the retain samples after stipulated time.
5.5  List of packaging material to be kept as retain sample
*1.  Cartons
*2.  Catch Covers
*3.  Inserts
*4.  Labels/Sticker labels
*5.  Printed Foil (Aluminium & Paper)
*6.  Plain Foil (Aluminium & Paper)
*7.  PVC/PVDC 
  8.  Rubber stopper
  9.  Flip off seal /Snap off Caps/Ropp Caps
 10.  Glass Vials
*11.  Glass Ampoules
*12.  Cellophane paper
*13.  Cryovac poly shrink film
*14.  Laminated pouch film
  15.  Plastic tray/Paper tray

6.0  ABBREVIATION

6.1  SOP - Standard Operating Procedure
6.2   Q.C.  =Quality Control





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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