LABELING in Pharma as per India-USA and EU regulation-lectures by Rajashri Ojha

Labeling in pharmaceutical industry

Drug labeling is also referred to as prescription labeling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug.

Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal.

The labeling process is critical to maintaining compliance.
Label act as a unique identifier to prove authenticity to health care professionals.
Label ensures that active ingredients and concentrations are clearly understood.
Good Manufacturing Practice (GMP) aims to minimize any risks associated with incorrect labeling.

A label always give benefit to customer about
The official product name,
Active and inactive ingredients with quantity,
Use,
Warnings and
Allergic reactions.


Labeling is beneficial for medical practitioners and patients.

Labeling is regulated or approved by regulatory authorities and should have 100% compliance with authority rules and regulations.

India
USFDA,
EMA

,
Purpose- Ensuring proper Packaging & Labelling Information of the Product

Global Harmonization going on everywhere.

The Food Safety and Standards Authority of India (FSSAI) was established under the Food Safety and Standards Act, 2006, as a statutory body for regulating the manufacturing, processing, distribution, sale, and import of food products as well as its labelling and packaging requirements.
Additional labelling requirements for packaged food products, as stipulated in Part VII of the Prevention of Food Adulteration (PFA) Rules, 1955, and the Standards of Weights and Measures (Packaged Commodities) Rules of 1977, require that the labels contain the following information:

Name, trade name, or description.
Name of ingredients used in the product in descending order of their composition by weight or volume.
Name and complete address of manufacturer/packer, importer, and country of origin of the imported food (if the food article is manufactured outside India but packed in India).
Net weight, number, or volume of contents.
Distinctive batch, lot, or code number.
Month and year of manufacture and packaging.
Month and year by which the product is best consumed.
Maximum retail price.
Wherever applicable, the product label also must contain the following information:
The purpose of irradiation and license number in case of irradiated food.
Extraneous addition of coloring material.

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