In our daily life, we often observe different types of labels on multiple containers e.g. food containers or medicine enclosures. Labels on medicines’ enclosures are also known as pharmaceutical labels.
Generally , a label is a means to convey some important message regarding a product to the end user. It can be about its nature, behaviours, advantages or disadvantages. If we don’t find the proper label of any food product, there may not be any issue. But, in the case of a pharmaceutical product, we must not accept it without a proper pharmaceutical label, showing adequate and authentic information.
Pharmaceutical label printing is a key requirement for accomplishment of pharmaceutical manufacturing, as pharmaceutical products are considered worthless and absolutely useless without its packaging and labelling is mandatory in pharmaceutical packaging by law. So, the pharmaceutical label printing is a legal requirement for pharmaceutical manufacturing.
Let’s start, as basic as the definition of a pharmaceutical label.
Introduction
Pharmaceutical label is a legal packaging requirement of pharmaceutical products. It may be written, printed and graphically designed obligatory data, conveyed to the end user, displayed on or inserted inside the package of a pharmaceutical product, for the purpose of safe and effective use of the product.
Notably, pharmaceutical label refers to the piece of printed or pasted information on the surface of a pharmaceutical container (primary label) as well as inserted inside the package as a leaflet (also called leaf insert, package insert or pharmaceutical package insert).
Printed labels are for blister or strip packaging of frequently available tablets and tubes of different gels, ointments and creams. Moreover, printed labels are also on secondary packaging e.g unit cartons. Pasted labels can be found on the surface of syrup bottles, draughts, suspensions and emulsion containers. These are common with liquid dosage forms.
Package insert is also referred to as a pharmaceutical label. It is detailed information, almost always enclosed in the package of each pharmaceutical product. It is relatively more detailed and sometimes serves as a continuation of label information. As we have seen, multiple times on pharmaceutical label ‘See Inside’ after any bold heading e.g. direction for use. So, due to being short of space, necessary information of pharmaceutical labels, we have a usual practice of printing it on package insert, with additional information.
Typically, with the words of ‘pharmaceutical label printing’, we get an understanding of printing the label to be displayed on the surface of an immediate pharmaceutical container. Therefore, we will further account for immediate or primary pharmaceutical label printing.
Objectives of pharmaceutical Labelling
- Identification of Pharmaceutical Product
- Description of medicinal product and its usage and method of usage
- Minimised medical errors and contribution to satisfactory therapeutic outcomes.
- Prevents supply of substandard and spurious (without any active ingredient) via proper Identification of Manufacturing and Marketing Company with address and licence no.
- Specification of conditions where the product should be avoided.
- Provides significant information about product e.g expiry date, registration no. etc.
- Preservation of product for long term usage by recognising its ideal storage conditions.
Components of Pharmaceutical Label:
Over-here, we will have a discussion about mandatory information, which is a legal requirement of pharmaceutical labels. Without these, a label is incomplete rendering a product worthless.
· Brand Name
Brand name or trade name is the name given by the proprietor, manufacturer or marketing company to their product. For example Panadol is the brand name of acetaminophen and Disprin is the brand name of acetylsalicylic acid.
Brand name is written/ printed in relatively bold and clear letters on pharmaceutical labels, as it gives recognition to pharmaceutical products. A single drug (pharmaceutical agent) can have multiple brand names in the market.
· Active Ingredient
Just below the brand names, there is a pharmaceutical formula written in the bracket. This formula is the Generic Name or Active Ingredient of the pharmaceutical product. Active ingredient is an actual working agent in any formulation and also a key requirement for pharmaceutical label printing.
Sometimes, there may be a requirement to mention inactive ingredients (excipients) on the label (as per nature of the product and the laws applicable) but usually these are either mentioned on package insert or kept confidential.
· Pharmacopoeia Reference for Specification
Pharmacopoeias are official referencing books of different pharmaceutical formulations. For instance, United State Pharmacopoeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (EP or Ph Eur). While printing press company a pharmaceutical label, we need to mention the reference of the official book (in abbreviated form), from which specifications of formulations were taken. Sometimes, the proprietor takes responsibility for specifications and designs his/her own product. In this case, the label must be tagged with the line ‘ As per Proprietor’s specifications’.
· Dosage and Strength with Appropriate Units
Dosage is the weight of the active ingredient added in the product, in milligrams, micrograms or grams. Strength is mentioned in case of liquid dosage form, where the unit of the vehicle varies from unit of active ingredients. For example, a tablet of augmentin may be 375mg, 625mg or 1 gram. But augmentin syrup will be found in 228mg/5ml or 457mg/5ml.
Dosage or strength should be clearly mentioned at a place corresponding to active ingredients, on pharmaceutical labels.
· Dosage Form
Dosage form shows the type of formulation. For example, tablets, syrups, creams, gels etc. It is also an essential point to introduce on pharmaceutical labels.
· Pack Size
Pack size is the quantity of unit doses of medicine packed in the container. For instance, a blister having 10 tablets will be specified as 10’s on a pharmaceutical label. If a pack of 10 litres (having 10 tablets per blister), will be denoted as 10 x 10’s.
· Dosage Administration
This is the pharmacologically safe and effective dose, indicated for relevant conditions. Dose is an important parameter to specify on label.
· Indications or Uses
These are diseases or conditions for which pharmaceutical product has been manufactured. It must find an appropriate place on the pharmaceutical label.
· Directions for Use
Directions or instructions for use constitute the procedure of administering a pharmaceutical product. For example ‘Shake Well before Use’, ‘Not to be taken with milk’ and ‘For External Use Only’
· Cautions or Warnings
Cautions or Warnings are important precautions, which should be kept in mind before taking medicine. These are highlighted by bold letters, red font colour, red box or black box. For example do not use in pregnancy, do not use hypersensitivity to active ingredients (or excipients) and not for breastfeeding mothers.
· Manufacturer’s Name and Address
Manufacturer’s name and its verified address is also mandatory while pharmaceutical label printing. Manufacturer’s Licence Number Licence no. of company, issued by authorised body, is also needed on pharmaceutical labels by law.
· Marketing Company’s Name and Address (If Applicable)
Sometimes, a company which owns a product, does not manufacture it, in its manufacturing plant (industry). Despite this, the product is surrogatedly manufactured in some other plant, on behalf of the owning company. In this case, the owner company is called a marketing company. Therefore, the complete name and address of the marketing company (if applicable) must be separately identified on the pharmaceutical label. For example Panadol Extra is manufactured by Pharmatec Pakistan, whereas it is owned and marketed by GSK Karachi.
· Batch Number or Lot Number
Batch or Lot no. are given by the manufacturer for the purpose of long term record maintenance. Any post marketing issue or adverse event can be addressed by recalling batch no.
· Manufacturing Date
It is abbreviated as Mfg. Date. it can be printed, engraved or stamped but must be available on label.
· Expiry Date
Expiry date (Exp. Date) should be easily readable on label, as after expiry date, a pharmaceutical product must not be administered.
· Product Registration/ Enlistment Number
Authorised body of the country issues a registration no. to every product after its approval for manufacturing and selling. It should have a place on the pharmaceutical label while printing.
· Storage Conditions
These may be
- Store in a cool and dry place
- Store at 2 to 8 C
- Store at room temperature
- Protect from heat and light
- Keep out of reach of children
- Inflammable; Do not expose to high temperatures.
Without this description, our pharmaceutical label is invalid and cant be approved by authorised departments.
Things to be kept in mind while Pharmaceutical Label Printing
- Image quality of pharmaceutical labels must be satisfactory.
- Font size must be easily and clearly readable. Usually 12 to 16 is used as per requirement of the end user.
- Font style should also be easily readable.
- Colours and graphics must not create any ambiguity in the reading test.
- It must contain all required genuine information.
- Labels should be easily differentiated in case of different doses of the same product.
- At Least primary labelling must not contain any marketing or appealing data.
- Pharmaceutical labels should be printed by using standard printing materials, like inks, colours and paper.
- Size of labels must be adequate, according to product containers
- Adhesives, used, must have sufficient strengths to bear handling and storage processes.
- All steps of pharmaceutical label printing must comply with guidelines of authorised bodies.
In a nutshell, pharmaceutical label printing is a legal requirement and mandatory part of the pharmaceutical manufacturing process. All required information must be authentically furnished in a pharmaceutical label. And all technical aspects must be considered while pharmaceutical label printing.
