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Example pharmaceutical packaging line. All aspects of pharmaceutical production, including packaging, are tightly controlled and have regulatory requirements. Uniformity, cleanliness , sterility, and other requirements are needed to maintain Good Manufacturing Practices. Product safety management is vital.
The child-resistant locking closure for containers was invented in 1967 by Dr. Henri Breault. [7]A history of accidents involving children opening household packaging and ingesting the contents led the United States Congress to pass the Poison Prevention Packaging Act of 1970, authored by U.S. Senator Frank E. Moss of Utah.
In line with local legislations, a pharmaceutical product should fulfill several labelling requirements for the purpose of registration: the product name, the name and quantity of each active ingredient, the name and address of the manufacture, Hong Kong registration number, batch number, expiry date and storage instructions, if any. [9]
The main advantages of unit-dose blister packs over other methods of packing pharmaceutical products are the assurance of product/packaging integrity (including shelf-life) of each individual dose and the ability to create a compliance pack or calendar pack by printing the days of the week above each dose.
Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc. or may be simplified to a one-page document called certificate of ...
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
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