What information should be presented on a label?

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 pharma manufacturers to pass regulatory requirements, and effectively market and sell their products in relevant countries.

Following regulatory compliance helps pharma manufacturers to facilitate drug approval process, preventing costly product recalls, and more importantly increases the company's reputation.

Ease of use

Labelling also helps in easily using a pharma product according to the disease or patients requirements. Because most of patients do not have high level of medicine knowledge and solely rely on products label for variety of information such as a drug identification, different warning, preparation method and expiry date. Label enables patients to effectively consume the drug according to the requirements.

Product safety

Labelling is an effective source to prevent counterfeiting, and tempering. Because the Pharma industry worldwide is increasingly becoming the victim of counterfeit and tempering, and poses damage to pharma manufacturer's reputation and patient safety

Track and trace system applied through product labelling enables tracking a product a product up to unit quantity level. This helps to easily verify a product, and to determine if the product is original or counterfeit.

Additionally labels can also be used to detect a product, if it has been tempered. This is ensured by using latest technique such as holograms, color shifting, micro text printing, voiding affects and special pigments.

How containers are labelled?

For the most packaging materials such as foil, catch convers and ampoules, labels are directly printed on them. For the critical information such as manufacturing date, expiry date, Serial and batch number are printed at the final stage, using a portable printer. For these, there is no need to label these.

However, for some packaging materials such as glass bottles and vials, labeling is required and is performed in a dedicated machine called Labeling Machine.

Labeling machine

Labeling machine is used to label a filled container with appropriate materials. Mostly used for glass containers such as vials and bottles, it uses mechanical method to paste a label using a glue.

The containers are fed to the machine through infeed, which includes a wheel to synchronize the incoming containers with the various stages and processes of machine.

After infeed, glue is pasted on the containers at the glue/pasting station. It consists of a round roller and a small container containing glue. The labels move past the roller, as it rotates. The round roller continuously rotates, adjacent to the container containing glue. As the roller rotates, the glue is sticked on the roller, and labels also get their share of glue. The labels are then transferred to the next station.

The next station is pasting station, where labels with glue are pasted on the glass containers. In this station, label are placed on a small flat mechanical piece, which moves in synchronization with moving containers. The mechanical pieces is gently forced against the glass container, causing the label to paste on the containers.

In the final stage, the labelled containers comes out of machine and are collected accordingly.

Regulatory Guidelines

As discussed above, labeling is an integral part of GMP requirements for regulatory bodies worldwide. Let's briefly discuss some regulatory guidelines for labeling pharmaceutical product enforced by the United States FDA

Unites States FDA

The United States 21 CFR part 201 is the GMP requirements for labeling pharma products that provides complete guidelines related to all aspects including what product require labeling, information on a labels and other necessary information like that.

This guideline consists of seven sub-parts from A to G, and contains the following guidelines

Subpart - A: it consists of general information on a label for a pharma product, and includes further 17 parts. The information in this part includes the following

• Pharma product manufacturer

• National Drug Code

• Directions

• Misleading statements

• Expiry date, and all other general requirements for labeling a pharma product.

• The use of term infant

• Declaration of presence of FD&C Yellow No.5, Yellow No.6, phenylalanine as a component of aspartame in drugs for human use.

• Pediatric studies,

• Antibacterial asymmetric studies

• Bar code requirements

• Exception or alternative to labeling for drug products held by Strategic National Stockpile

Subpart - B: it provide guidelines for labeling prescription products and Insulin, and further includes five parts. The information in this part include

• Identity

• Declaring of net quantity

• Dosage

• Content and format of label

• Product that are waived from labeling requirements

Subpart - C: it provide guidelines for labeling "Over the Counter" drugs, and further includes ten parts. The information in this part include

• Display panel

• Identity statement

• Declaration of quantity

• Warning for Pregnancy / breastfeeding

• Sodium, Calcium and Magnesium labeling

• Format and content

Subpart - D: it provide guidelines exemption of 502(f)(1) for section 503(b)(1) for different drug types such as

• Human use

• Veterinary

• New drugs

• Common directions

• Inactive ingredients

• In vitro diagnostics

• Prescription chemicals

• Processing, repacking and manufacturing

• Teaching law enforcement, research and analysis

Subpart - E: it provide guidelines for exemption of other drugs, and consists of two further parts. This sub-part also exempts medical gases (oxygen, nitrogen, carbon dioxide, helium, and nitrous oxide). Additionally, in case of Oxygen, specific warning information must be labeled on it. For example, it states that oxygen may be labelled, as

• Un-interrupted use of high concentration of oxygen over a long duration , and without monitoring the effect of oxygen content of arterial blood may be harmful

• Oxygen should not be used on patients who have stopped breathing, unless used with any equipment

• Additionally, this guideline also indicates some special warning that must be labeled for Nitrogen, Carbon dioxide, Helium, Nitrous Oxide, or (medically fit) combination of any these gases.

Subpart - F: it provide guidelines for labeling claims for drugs in efficacy studies and consists of only one part.

Subpart - G: it provide guidelines for specific labeling requirements, and contains 19 sub-parts.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.