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.
Gist of 31 Chapters on Schedule M
Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Revised Schedule M: The Role of Pharmaceutical Waste Management
Gap analysis for Revised Schedule M
Important short notes for Industry and Regulators
Key Notes on Revised Schedule M: Compilation
India allows Clinical Trial waivers for Drugs from these 6 Countries
USFDA approval granted for Acitretin Capsules USP
New Rules accelerate Drug Approval Process in India
Gujarat FDCA Launches Crackdown on Fake Drugs: Special Flying Squads Formed
Govt Job: For Pharmacists in Indian Railways – 246 posts
USFDA warns of Quality Issues with Chinese Plastic Syringe
Data integrity is the biggest issue in Pharma Industry: USFDA official
USFDA issues OAI Classification to Aurobindo Pharma Bhiwadi Facility
Indian Pharma industry urges NPPA for stable drug pricing policy
IPHEX 2024: Your Gateway to Indian Pharma Market
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
