Last Updated on August 13, 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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