Good Manufacturing Practices (GMP) standards

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Overview:

Recently, the government of India has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) for pharmaceutical companies which were revised in 2018, bringing them on par with World Health Organisation (WHO) standards

About GMP: 

 

  • Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
  • It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
  • It covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.
  • The GMP system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was done in June 2005. WHO-GMP standards are now part of the revised Schedule M.
  • There are around 10,500 manufacturing units in India out of which around 8,500 fall under Micro, Small and Medium Enterprises (MSME) category.
  • The country has about 2,000 units in MSME category in the country having WHO-GMP certification.

 

What are the new regulations?

  • Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, 
  • Medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year

 


Q1) What is WHO?

WHO stands for the World Health Organization. It is a specialized agency of the United Nations responsible for international public health. Established in 1948, the WHO's headquarters is located in Geneva, Switzerland. The organization's primary objective is to promote and coordinate global health efforts, address health emergencies, and improve healthcare access and standards worldwide.

Source: Adopt WHO-standard good manufacturing practices: Govt sets deadline for pharmas