MEDICAL & PHARMA

  
Vinod Kumar
Published :




  

MEDICAL & PHARMA

Medical and pharma packaging standards are developed to ensure that medical and pharmaceutical products are properly protected during storage, transportation, and use and that they maintain their efficacy and safety throughout their shelf life. Some of the major packaging standards and guidelines in this area include:

  1. US FDA 21 CFR Part 211: This is a regulation that sets out the requirements for the production, testing, and control of drug products, including their packaging and labelling.

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  1. ISO 11607: This is an international standard that provides guidance on packaging for terminally sterilized medical devices.
  1. USP General Chapter <659>: This is a general chapter in the United States Pharmacopeia that provides guidance on packaging and storage requirements for pharmaceutical products.
  1. ASTM D4169: This is standard practice for performance testing of shipping containers and systems used to transport medical devices and products.
  1. ISTA Series 3A: This is a series of performance tests that assess the ability of packaging systems to withstand the hazards of distribution.
  1. EU Good Manufacturing Practice (GMP) Annex 1: This is a guideline that sets out the requirements for the manufacture of sterile medicinal products, including their packaging and labelling.

Compliance with these standards and guidelines is critical for ensuring that medical and pharmaceutical products are properly packaged and protected and that they meet the necessary regulatory requirements for safety and efficacy.


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