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:
- Design control, including design validation and control of design output and changes for labeling and packaging;
- Control of packaging and labeling processes including personnel training, process validation, work instructions, process monitoring, and process records;
- Inspection and final acceptance of packaging and labeling; and
- 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?
|
Disclaimer:
Although
the author had exhaustively researched all sources to ensure the
accuracy and completeness of the information contained in this blog,
but no warranty and fitness is implied. I assumed no responsibility
and implied warranty of any kind for errors, inaccuracies, omission,
or any inconsistency herein. No liability is assumed for incidental
or consequential damages in connection with the use of the
information contained herein. Readers should always use their own
judgment and review all related regulatory guidelines. Guidelines can
change over time.
