Page 10 - Packaging Controls
P. 10
GMP Training – Packaging Controls by www.gmpsop.com
GMP controls at the printers
Pharmaceutical labelling suppliers are a major component of a successful
packaging and labelling process. Their adherence to change control and GMP
compliance should be as strong as for the manufacturers themselves.
Routine audits of the printed matter suppliers to GMP standards are needed.
The audit should focus on the printer's line clearance practices, the printer's
counting accuracy and an acceptable system for handling and disposing of
waste.
Printers should follow written and GMP-approved operating procedures in order
to tighten packaging and labelling control. Being able to trace materials and good
record keeping are needed to help prevent mixups. Where different batches of
printed material are being produced at the same time, they should be physically
separated from one another to ovoid mix-ups.
Other in-process controls at the printers include:
using identification numbers that are unique to each revision
optical bar codes for verification
artwork control
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 10 of 37
