Page 26 - Packaging Controls
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GMP Training – Packaging Controls by www.gmpsop.com
specifications. Control charts are established based on statistical theory
regarding process variation. If your company is using a charting approach to
controlling processes, ensure that you have trained in their use and
interpretation.
Auditing a Packaging Operation controls
During the quality assurance audit the following parts of a packaging and
labeling operation must be audited.
Essential packaging and labeling information
Mix up risks and prevention
Cross contamination
Packaging Order
On-line controls
Sampling
Labeling
Documentation
Reconciliation
Rework
Line Clearance
AUDITING A PACKAGING OPERATION
Essential packaging and labeling information:
The packaging and labeling must include:
Identification of the product
Final finished dose form (tablets, capsules,
injection)
Strength of each individual unit
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