Labeling and Packaging Part II

Product packaging and labeling must be treated as an integral part of the medical device itself. Therefore, the product is not completed and could never be released for distribution before it is packaged and all specified labeling and packaging requirements of the quality management system fulfilled. For example products manufacturing must also apply to labeling and packaging as well. 

Therefore, any operational procedures and other quality system documentation related to packaging and labeling must be followed, examples are shown below:

1) Design control, including design validation and control of design output and changes for labeling and packaging;

2) Control of packaging and labeling processes including personnel training,

process validation, work instructions, process monitoring, and process records;

3) Inspection and final acceptance of packaging and labeling; and

4) Establishment and maintenance of necessary records for labeling and packaging.

The following talks about labeling and packaging design and validation. Labeling and packaging design and validation must also be carried out like it is an integral part of the product. 

1) Labeling and packaging, and their artwork, are developed in the phase of product design as in any part of the medical device itself. The development processes are implemented in accordance with Operational Procedure for Design Control, to include requirements for design input, design planning, documenting and controlling design output, conducting design reviews, and verifying and validating the labeling and packaging design.

2 ) For example, medical device products to be marketed in the European Union and South Korea, labeling and instructions for use are translated into foreign national languages versions according to the intended plan for placing the product on the respective market. The translation process and the correctness of the translations is undertaken according to the procedures. For examples, translation must be done by qualified translators.

3) When packaging is designed to meet certain performance requirements, such as sealing the product to protect it from heat, light or contaminants; or structural ability to withstand stacking or shipping loads, the packaging is validated by testing it under actual or simulated conditions of distribution, storage and use. For example, when the medical device is intended to be marketed in a region with high temperature and humidity. The product packaging must be validated again humidity and relative humidity.

4) Packaging for sterile products is likewise validated to test packaging materials and the seal. There are many types of sterilization techniques such as Wet/steam sterilization, Dry heat sterilization, Ethylene oxide, Sporicidal chemicals, Glass Plasma and Irradiation (Gamma rays).

 

5) Labeling integrity is validated to ensure that labels will remain in place and be legible under normal operating and use conditions. There are many requirements for label like what symbols to use, what font size to use and manufacturing site and expiry are some examples of key information printed on the labels.

Reference	Criteria
820.12	Has the company established and maintained procedures to control labeling activities?
820.120 (a)	Are labels printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and use?
820.120 (b)	Has it been established that labeling is not released for storage or use until a designated individual has examined the labeling for accuracy?
820.120 (b)	Is the release of labeling, including the date and signature of individuals performing the examination, documented in the device history record (DHR)?
820.120 (c)	Has the company stored labeling in a manner that provides proper identification and is designed to prevent mix-ups?
820.120 (d)	Does the company control labeling and packaging operations to prevent labeling mix-ups?
820.120 (d)	Are the label and labeling used for each production unit, lot, or batch documented in the device history record (DHR)?
820.120 (e)	For devices where a control number is required by product traceability requirements, is that control number on or does it accompany the device through distribution?