6 Requirements for Manufacturing Pharma Labels

For a patient label present over any pharmaceutical product is generally the only source to know how such product works, what are its constituent elements and how they have to take it. As such pharmaceutical companies need to pay adequate attention to correct pharmaceutical label printing for all the products they manufacture.

In addition to providing details about the medicine, labels also contain important information like manufacturing as well as expiry date for the product and how many doses patient has to take.

As such we cannot even imagine how it would be without proper labeling of pharmaceutical products. In this context let us go through some of the pharmaceutical labeling requirements manufacturers need to follow.

Six Requirements of Pharmaceutical Label Manufacturing

Requirement #1: Following Government Regulations

According to government directives it is mandatory that each and every pharmaceutical product has necessary labeling. This regulation is applicable irrespective of whether it is any type of OTC medication, prescription drug or a medical device.

Requirement #2: Responsibility of Labeling

As per this requirement the label is to be designed and applied in a way that it stays in its place as well as is properly readable in all environments. This requirement should be met over lifespan of the product right from the time it is distributed, stored and used by end user.

In addition to it, pharmaceutical label printing needs to be legible and has to remain same for the time a pharmaceutical product is being used. Additionally, label has to adhere to content and format requirements mentioned in regulations.

Requirement #3: Display of Product Information

There are certain requirements which are to be followed with respect to claims and information which are be displayed on labels. Some of the details which must be added onto labels consist of:

• Name of the product

• Warnings

• Table displaying facts about the drug

• Information about allergic reactions

• Active and inactive ingredients present in the drug

• Directions for use

• Purpose of the drug

Requirement #4: Formatting of Label

Another of the pharmaceutical labeling requirements relates to use of specific format based on nature of product. Few of the things which are to be kept in mind while labels are designed include:

• Size of font as well as its type need to be legible.

• It should use right grammar, claims and abbreviations.

• Correct format is to be used for organizing different sections like drug facts, warnings and uses.

• Labeling material is to be chosen depending on nature of pharmaceutical product.

Requirement #5: Selection of Material

Selecting the right material is also quite important and some of the options include shrink sleeve labels, white paper and holographic films. Additionally, it is to be ensured that adhesives, coatings as well as inks do not leak and get into drug stored in the container.

Requirement #6: Quality Control

It is also to be ensured that information added on the label is consistent as well as accurate.