Page 36 - Packaging Controls

GMP Training – Packaging Controls by www.gmpsop.com

Summary

This module highlighted the importance for instituting packaging and labelling
controls al a pharmaceutical manufacturer. GMP rules dictate that these
controls are in place in order to ultimately protect the customer from mislabeling
errors. Specific packaging and labelling controls govern:

Printed matter (e.g., control, over artwork and printers, limited access to the
label store, disposal of obsolete and rejected printed mailer)

Validation of counting equipment

QC sampling

Line clearances

Continuous monitoring of critical process parameters

Online controls, such as:
- Material and label identification

- Count (or measure) of the filled container
- Seal integrity
- Label verifier function
- Coding
- Pack appearance

Reconciliation

Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 36 of 37