Packaging and labeling operations

The packaging and labeling operations to be done in close proximity to other packaging and labeling operations... 

SUBPART g packaging and labeling control 211.122 Materials examination and usage criteria 211.125 Labeling issuance 211.130 Packaging and labeling operations... 

Packaging Materials Label Issuance and Control Packaging and Labeling Operations Storage and Distribution Warehousing Procedures Distribution Procedures... 

The formal validation is often completed after the PAI, where three-batch process validation will be conducted in accordance with the protocol approved during the preapproval inspection. The primary objective of the formal process validation exercise is to establish process reproducibility and consistency. Such validation must be completed before entering the market. The formal validation studies continue through packaging and labeling operations (in whole or in part), so that machinability and stability of the finished product can be established and documented in the primary container-closure system. 

A sample packaging record(s) that describes the packaging and label operations also should be included with the manufacturing and control record and the completed production and control record for a typical batch. 

This subpart covers one of the aspects of pharmaceutical production that has received much attention because of recalls, including an increase in recalls related to labeling errors or product mix-ups associated with the packaging and labeling operation. Specific requirements identified in this section recently include the following. 

Whenever possible, formal validation studies should continue through packaging and labeling operations (whole or in-part), so that machinability and stability of the finished product can be established and documented in the primary container-closure system. 

Upon completion of the packaging and labelling operations, a comparison should be made between the number of items labelled and packaged plus the number of units not used. All coded unused units should be destroyed. Any significant or unusual discrepancy in the numbers must carefully be investigated. 

Packaging and labelling operations are often performed after the release of the bulk product and in accordance with specific requirements of different trials. These operations are of paramount importance for the integrity of clinical trials. In this respect, self inspection or independent audits, as referred to in the Community... 

Separate packaging and labelling operations of hermetically sealed containers are not subjected to section C.02.029 but are covered under section C.02.011. 

Any remaining labels after packaging and labelling operation should be counted and then either returned or destroyed. 

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