Monday, November 2, 2015

Label Control

Controlling the storage and issuing of labels and labeling helps prevent mix-ups. Technology, such as bar-codes and vision systems, has reduced the number of   label - related recalls, but controlling label storage and issuance is still very important.

General Precautions

1. When setting up a program for the packaging operations, particular attention should be given to minimizing the risk of cross-contamination, mix-ups or substitutions. Different products should not be packaged in close proximity unless there is physical segregation.
2. Before packaging operations are begun, steps should be taken to ensure that the work area, packaging lines, printing machines and other equipment are clean and free from any products, materials or documents previously used, if these are not required for the current operation. The line-clearance should be performed according to an appropriate check-list.
3. The name and batch number of the product being handled should be displayed at each packaging station or line.
4. All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity and conformity with the Packaging Instructions.
5. Containers for filling should be clean before filling. Attention should be given to avoiding and removing any contaminants such as glass fragments and metal particles.
6. Normally, filling and sealing should be followed as quickly as possible by labelling. If it is not the case, appropriate procedures should be applied to ensure that no mix-ups or mis-labelling can occur.
7. All labeling materials should be coded in such as manner that the code reveals the material and indicates that the material is the one currently in use. As a corollary, it must be ensured that when there is any change in the label copy matter, the code number is suitably amended.
8. Normally filling and sealing should be followed immediately by labeling, if it is not the case appropriate procedure should be implemented to ensure that no mi-ups and mislabeling can occur.

1. Only designated people should have access to label control areas; this must be strictly enforced.
2. Labels and printed materials should be released as required by packaging instructions that have been approved by the quality unit.
3.The labels and labeling must be securely transported to the packaging and labeling lines, usually in locked containers or cages.
4. As new printed materials are brought to the packaging line, they are accepted for use only after they have been closely examined and verified as being correct.

New technologies such as digital online printing and the use of 2D barcodes, radio frequency identification devices(RFIDs), and mass serialization (i.e., putting a package-specific serial number on each packaging of a drug product) that are intended to thwart counterfeiting, are making labeling operations even more complex. These elements and processes will also need to be established, validated, and controlled to assure they contribute to maintaining identity and preventing mix-ups.

Printing quality and substance

All types of labeling have content requirements for what types of information and claims can be stated on a label. Each drug and medical device classification has their own set of requirements for what information should be shown on the product.  Several important things to include on a pharmaceutical or healthcare product label:

•           Official product name
•           Active and inactive ingredients
•           Drug Facts table
•           Purpose and use
•           Warnings
•           Directions
•           Allergic reactions

•  Primary packaging labels identify the product, its origins and batch number, directions for use, warnings, and other required patient information.(Label copy is approved by national authorities)
•  Any information or content that is to be used on a label or labelling must be securely maintained in validated computer systems.
• Printed and embossed information on packaging materials should be distinct and resistant to fading and erasing.
• Labelling materials should be so design and printed that there is a marked differentiation between labels, cartons etc. of different product and different dosage form/strengths of the same product. This can be achieved by using different shapes, different colours and different sizes.
•  For further product safety, you should choose adhesives, coatings and inks that are “low migration” meaning that little to no substances transfer from the materials to the drug or device.

Packaging and labelling errors remain among the leading causes of drug product recalls in both the United States and Canada.

** For FDA
Labels must be designed in the appropriate FDA format for your product’s classification like OTC medications, oral contraceptives, combination products, etc. Click here for a list of labeling guides relating to drugs. Some things you should consider when designing labels for FDA approval:
•  Font size and type (must be legible)
•  Language (appropriate use of abbreviations, grammar, advertised claims, etc.)
•  Format (organization and appearance of sections like Drug Facts, warnings, uses, etc.)
•  Materials (depending on the nature of the product)


Labels are only issued when a properly authorized packaging work order is presented.

1. Any labeling or packaging material should be release or rejected based on return specific requirement.
2. Labelling materials issued for a batch shall be carefully examine for identity and conformity to the labeling specified in the master or batch production records.
3. Records shall be maintain for each shipment received of each different labeling packaging material indicating receipt, examination or testing and whether accepted or rejected.
4. Strict control should be exercised or material issued for used in drug product labeling operations. Error of this stage can some time lead to serious consequences. Miss labeling is one of the most frequent causes of product hazards and product recall. It is there for necessary to control the receipt, testing and issuance of labeling materials. Even the purchase, handling and control of primary and printed packing materials should be accorded attendance similar to that give to starting material.
5. All labeling materials should be held under quarantine, until cleared by Quality Control.
The packaging work order (or packaging instructions) is the authorization to packaging and label a specified quantity of a drug product batch named on the order. It also serves as a quantity of a drug product batch named on the order. It also serves as a requisition to withdraw from stock all the components and materials needed to complete the operation, including bulk product, packaging components, and printed labeling materials.
At the time of issues, a qualified person checks label for correctness and quantity. A formal record is made including:

•           Identification of the labelling material;
•           Code number, if applicable;
•           Batch or lot number of the labels;
•           The amount issued;
•           The personnel issuing the labels;
•           The date of issue.

Storage issues

1. Labels and labeling material for each different drug product, strength dosage form shall be stored separately with suitable identification. Access to the storage area should be limited to authorized personnel.
2. To prevent labeling and packing errors, a know and recorded number of properly coded labeling materials should be issued with proper security against signed packaging order that indicates quantity and type of labeling materials required for packaging operation.
3. Obsolete, out dated labels foils, cartons and other packaging material should be rejected and then destroyed. Necessary documents/records should be maintained.
4.  Printing devices on or associated with manufacturing lines used to imprint upon the drug product until label, carton or case shall be monitored to assure that all imprinting conforms to the print specification.
5.  Particular attention should be paid to printed materials. They should be stored in an adequately squared condition saw as to excluded unauthorized access. Cut label and other loose printed material should stored and transported in separate close containers so as to avoid mix up. Packaging material should be issued for use only by authorized personnel, following in approved and documented procedure. 
6.   Labeling returns to the stores shall be maintained and stored in a manner to prevent mix-ups and proper identification.

•   Control over labels and the labeling operation is absolutely critical
• As with other packaging components, labels, including cartons and other printed materials such as product inserts (labelling), are quarantined upon receipt, sampled, and examined against their specifications prior to their release for use in packaging/ labelling operations. Labels are stored at all times in a limited access area, typically a locked room or cage.
Personnel must be specifically authorized for access to the label storage area. The number of personnel with such access is kept to a minimum. The label storage area is adequately supervised at all times.

Label Rejection or Destroy

1.   On-line rejected primary packaging material or printed material should be destroyed and this disposal recorded. Excess leftover printed materials with batch details also should be destroyed to avoid mix-up.
2.  On completion of a packaging operation, any unused batch coded packaging material should be destroyed and the destruction recorded. A documented procedures should be followed if uncoded printed material is returned to stock.
3.  Sample taken away from packaging line should not be returned. They should where appropriate, be destroyed (e.g. Leak tested strips).

Periodic validation should be conducted to ensure that electronic code readers, label counter or similar devices operating correctly. Necessary in-process checked and record should be maintained.

On-Line Control

On-line control of the product during packaging include at least checking following:
* General appearance of the packages
* Whether the packages are complete and the count is as per specification
* Whether correct products and packaging materials are used
* Whether overprinting if any, is corrected
*  Correct functioning of line controls. 


1. Responsibility for the storage and issue of such materials should at all times, be assigned to a person designated for this purpose by the factory management.
2.Quality Control should checked among other thing like dimension, colour etc. the accuracy of all printed details in order to ensure that the copy matter is in accordance with the current statutory and in company requirements of labelling. Printed matter and colour of all packaging materials should be checked against approved specimens, which match with approved artwork that has been duly sign and dated by quality control, purchase, packaging materials development departments. For control of variation in colour, the vendor should provide shade cards should be approved standard, light and dark shades. There shade cards should be approved by quality control, and it must be ensured that all supplies are within the acceptable rang.

Retest/ Special case
1. Product lots which have been involved in special events (like rework/ re-inspection in part or whole) should be re-introduced into process only after additional inspection and approval is carried out by appropriate authorised personnel. Detail record of any such deviation should be maintained.
2. Any significant and unusual discrepancy observed during reconciliation of the amount of bulk product and printed packaging materials and the numbers of units products produced should be investigated and satisfactorily accounted for before final release of the packaged product.
3. Usage of packaging material during rework should be recorded separately whenever necessary.

Over printing

Frequently, printed packaging components must be overprinted with batch specific information, i.e., product lot number and expiry date. Often, this is integrated into the labeling operation; occasionally, it is a separate off-line activity. In either case, over-printing must be carried out in accordance with the specific instructions provided on the packaging work order, with the details being recorded on the work order.
A number of different methods can be used for overprinting, such as meal type, rubber stamp, and ink jet.

When overprinting is performed off-line, checks must be made to ensure that the overprinting equipment and surrounding area are clear of all traces of the materials handled previously and that the equipment has been set up properly for the print run to be carried out. (this is a type of clearance) the following checks must be recorded on the packaging work order:

• The number of items taken for overprinting;
• The number overprinted;
• The number of spoiled items;
An explanation of any discrepancy outside the prescribed limits, between the number of items issued and the number accounted for.

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