Guidelines on Packaging for Pharmaceutical Products | Part IV

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Labelling

Throughout manufacturing, a succession of specific outer labels are applied to the container of the medicinal product.

The level of processing is indicated by the following words:
— quarantine
— storage
— distribution

Specifications for labels for finished drug products are defined in the WHO guidelines on GMP for pharmaceutical products.

Written labels on the packaging

  • Permit the identification of each active ingredient by means of its INN, and also give the dosage form and the trade name/trademark.
  • All information concerning the medicinal product, as required by national legislation, must be stated on the packaging.
  • Preserve the stability of the medicinal product by giving advice on its storage:

After the stability of the product has been evaluated, one of the following recommendations as to storage conditions can be prominently indicated on the label:

  • store under normal storage conditions;
  • store between 2 and 8 °C (under refrigeration, no freezing); — store below 8 °C (under refrigeration);
  • store between -5 and -20 °C (in a freezer);
  • store below -18 °C (in a deep freezer).

Permit the follow-up of a specific medicinal product by means of the batch number on the labels. It must be possible to follow the route of distribution of a product from the manufacturing process to its administration to the patient with the aim of locating and identifying products that are of potential risk (e.g. blood products, blood-derived products).

Mask the real identity of the medicinal product in clinical studies. This is extremely important in clinical trials in determining the real efficacy of a medicinal product in blinded studies.
If the identity is masked by a code, it must be possible to disclose it at any time in a medical emergency.

National legislation must be followed with regard to the information provided to the patient, as well as the record-keeping and packaging instructions.

Labels of Pharmaceutical finished products

1. All finished drug products should be identified by labelling, as required by the national legislation, bearing at least the following information:

(a) the name of the drug product;

(b) a list of the active ingredients (if applicable, with the International Nonproprietary Names), showing the amount of each present, and a statement of the net contents, e.g. number of dosage units, weight or volume;

(c) the batch number assigned by the manufacturer;

(d) the expiry date in an uncoded form;

(e) any special storage conditions or handling precautions that may be necessary;

(f) directions for use, and warnings and precautions that may be necessary;

(g) the name and address of the manufacturer or the company or the person responsible for placing the product on the market.


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Resource Person: BARBARA PIROLA

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