CDSCO mandates WHO TRS Guidelines for Sterile Product Manufacturing

The CDSCO's directive is clear: manufacturers must align their operations with the latest WHO TRS guidelines.

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WHO GMP World Health Organisation Good Manufacturing Practice
WHO GMP World Health Organisation Good Manufacturing Practice

Last Updated on August 20, 2024 by The Health Master

WHO TRS

WHO TRS Guidelines: The Central Drugs Standard Control Organisation (CDSCO) has issued a letter to all vaccine and sterile product manufacturers in India.

The regulatory body has mandated strict adherence to the World Health Organization’s (WHO) Technical Report Series (TRS) guidelines 1044 Annexure 2 (WHO TRS 1044 Annexure 2) on sterile products.

This move is a direct consequence of the revised Schedule M, a set of stringent regulations governing the pharmaceutical industry.

What Does This Mean for Vaccine and Sterile Product Manufacturers?

The CDSCO’s directive is clear: manufacturers must align their operations with the latest WHO TRS guidelines.

This includes a comprehensive overhaul of production processes, quality control measures, and sanitation standards.

The revised Schedule M outlines specific requirements such as:

  • Clean room standards: Maintaining immaculate production environments to minimize contamination.
  • Airborne particle control: Implementing measures to reduce the presence of particles in the air.
  • Microbial contamination limits: Enforcing strict standards to prevent product contamination.
  • Robust quality control: Ensuring product safety and efficacy through rigorous testing.

The Impact on MSMEs

The pharmaceutical industry, particularly the Micro, Small, and Medium Enterprises (MSMEs) segment, is facing a significant challenge.

The implementation of the revised Schedule M requires substantial investments in infrastructure and technology.

Consequently, MSMEs have been urging the government to extend the compliance deadline.

A Step Towards Better Patient Safety

While the new regulations may impose a financial burden on manufacturers, especially MSMEs, they are ultimately aimed at safeguarding public health.

By adhering to the WHO TRS guidelines, pharmaceutical companies can ensure the production of high-quality, safe, and effective medicines.

This move is expected to enhance patient confidence in the Indian pharmaceutical industry.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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