Pharmaceutical finish product requires various requirements for an effective, compliant and safe drug product. One of them are the label on the Pharmaceutical products. It serves many purposes for a pharma product such as compliance, product identification, ease of use, and many more like that. Without a proper label, regulatory bodies do not allow a pharma manufacturer to manufacture pharma product, and it is impossible to market and sell product in almost all countries around the world.
Labelling provide the mean for a Pharma manufacturer to develop a method that facilities manufacturing drug without any mistake and difficulty. It also helps the consumer to utilize it without any problem.
Like other food and human consumables, Pharma product must be labeled in an approved and effective manner, because of the products sensitivity. Otherwise the Pharma manufacturer will face difficulty in approving product and can result in product recall.
What is the label in Pharma?
A label is a written, graphical or combination, or both for identification of a particular pharma product. This identification or label is printed on the drug container, and is mainly used to identify a particular product. it gives essential and valuable information about a drug, which is then used by all relevant stakeholders, such as supply chain, distributors, retailers and most importantly the patients and doctors.
The type of information on a label is regulated according to the regulatory requirement of a particular market or country.
What information should be presented on a label?
Different regulatory bodies have their own labeling requirements and must be followed accordingly. Below are some requirements of information on a label according to the United States FDA.
Name and place of manufacturer
The label must contain, name and place of the product manufacturer, partner or distributor. If this information is not available on the label it is declared a miss - branded. An entity is described as a manufacturer who performs manufacturing operations and include mixing, granulating, milling, molding, lypholizing, tableting encapsulation and filling sterile products into dispense container.
National drug code
NDC is issued by United States FDA, and it is the database of all the commercially available drugs in the United States.
The label can also contain, although not necessary, the national drug code which contains a detailed information about a specific product. The NDC includes, manufacturer, strength, dosage form, formulation and pack sizes.
There are different formats of NDC. Some products have 10 digits, some have 11 digits, while other have 12 digit format.
Usage
Usage is the direction for safe and effective use of a pharma product. It's main purpose is to enable a layman to use the product safely, and for the purpose for which it is intended.
The usage consist of following information.
All conditions , purposes or used for which the drug is prescribed, recommended or suggested
Quantity for which it is intended for persons of different ages and physical condition.
Frequency - how many times the drug is taken in a day
Duration during which the drug is required to be used
Time
Route or method through which the drug is used
Preparation instructions
Ingredients
The label must contain ingredients, from which it is manufactured. It must contain all the substances in the formulation.
Importance of labeling
Let's look at the importance of labeling and discuss why it is implemented in the pharmaceutical industry
Regulatory requirement
Like other requirements, labeling is a part of GMP requirement of all regulatory bodies around the world. Implementing labeling practices as laid down by regulatory bodies, enables...
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