Labeling and Packaging Part II

1) Labels and packaging are inspected and approved before they are stored, and are available for use in the packaging/labeling area. The inspection is performed by designated and qualified QC inspectors. QC inspectors must be trained and to have training record and other qualification to prove such qualification. 

2) Labeling/packaging inspection includes verification that:

  

2.1 ) The labels and packaging are printed using approved and appropriate (current revision level) artwork.

2.2) The materials like paper and ink and printing comply with specification, the quality and ink must also be great to ensure the paper and ink cannot deteriorate beyond legible and durable for years and

2.3)  Correct expiration dates, control numbers, lot number and serial numbers are used.

2.4 ) All the symbols were correctly used.

2.5 ) All translation was done right and verified to be so.

3) Results of the inspection and the date, name and initial of the individual inspectors performing the inspection are recorded in the production work order pertaining tolabeling and packaging operations.

4) Inspected and accepted labels and packaging are stored in designated cabinets in
the labeling/packaging area. Designated cabinets should be marked clearly. Where
mix-up of similar looking labels is possible, the labels are stored in separate cabinet

5) Should there be any out of specification labeling and packaging materials, they must be immediately quarantined and separated and conspicuously marked as such to
prevent Out of Specification (OOS) being accidentally being used.

Packaging and Labeling Operations

1) Packaging and labeling operations and processes should be considered production processes. All process control requirements and procedures that apply to manufacturing also apply to packaging and labeling. The operational procedures and other quality system documentation related to: 

1.1 Design transfer, e.g., development of packaging and labeling processes. 

1.2 Validation of special processes (in particular, packaging processes for sterile products, electrical testing, drop test etc)

1.3 Process control and monitoring activities.

1.4 Inspecting and testing the packaging and applied labeling.

2) Before commencing packaging or labeling operations for a new product or batch, the area is cleared of any packaging or labels left over from previous operations. This is to prevent mix-ups and the inadvertent use of wrong packaging or labels, for example, labels intended for a different product or with wrong control numbers or expiration dates.

3) The packaging and labeling operations, and the associated inspections and verifications are called out in the production work order. 

4) The inspections are part of the finished product acceptance, as documented in Operational Procedure for Final Acceptance Inspection. 

5) Where applicable, expiration dating and any control numbers are recorded in the work order exactly as they appear on the applied labeling.

Reference	Criteria
ISO 13485, 7.5.5.	Has the company established documented procedures or work instructions for preserving the conformity of product labeling during internal processing and delivery to the intended destination?
ISO 13485, 7.5.5.	Does this preservation include identification, handling, packaging, storage and protection?
ISO 13485, 7.5.5.	Has the company established documented work instruction for the control of product with a limited shelf life or requiring special storage conditions?
ISO 13485, 7.5.5.	Are special storage conditions controlled and recorded?
ISO 13485, 7.5.5.	Have procedures been implemented to ensured, where relevant, that labelling and instructions for use are translated correctly into foreign national languages versions according to the intended plan for placing the product on the market?
ISO 13485, 7.5.5.	Is it ensured, where relevant, that requirements for e.g. national language versions are checked and controlled in connection with dispatch, storage, etc.?
ISTA 208, 2A	Is the product withstand all tests stated in the ISTA guidelines
ASTM D-5276-98	Is the product withstand the free fall drop test?
ASTM D-5487-98	Is the product withstand vertical shock test?

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.

Labeling and Packaging Part I

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
ISO 13485: 7.5.5	Has the company established documented procedures or work instructions for preserving the conformity of product labeling during internal processing and delivery to the intended destination?
ISO 13485: 7.5.5	Does this preservation include identification, handling, packaging, storage and protection?
ISO 13485: 7.5.5	Has the company established documented work instruction for the control of product with a limited shelf life or requiring special storage conditions?
ISO 13485: 7.5.5	Are special storage conditions controlled and recorded?
SO 13485: 7.5.5	Have procedures been implemented to ensured, where relevant, that labelling and instructions for use are translated correctly into foreign national languages versions according to the intended plan for placing the product on the market?
ISO 13485: 7.5.5	Is it ensured, where relevant, that requirements for e.g. national language versions are checked and controlled in connection with dispatch, storage, etc.?
ISTA 208, 2A	Is the product withstand all tests stated in the ISTA guidelines
ASTM D 5276-98	Is the product withstand the free fall drop test?
ASTM D 5487-98	Is the product withstand vertical shock test?

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.