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.