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 a suitable place.
5.2 Keep the retain sample of packing material other than mark with * as per list 5.5 in the separate box properly labeled.
5.3 Store the retain sample of packaging material for 3 years.
5.4 Destroy the retain samples after the 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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