Last Updated on June 12, 2024 by The Health Master
Schedule M
The Indian pharmaceutical industry, a global leader exporting medicines to over 200 countries, is undergoing a significant transformation. The recently revised Schedule M guidelines, outlining stricter Good Manufacturing Practices (GMP), are driving this change.
At the forefront of this adaptation are new-generation air quality solutions that ensure pharmaceutical products meet the most stringent quality and safety standards.
Why is Air Quality Control Critical in Pharma Manufacturing?
Airborne moisture poses a significant threat to pharmaceutical product quality and stability.
Here’s how:
Organic Corrosion and Biochemical Reactions:
Moisture can trigger the breakdown of medications through organic corrosion and accelerate unwanted biochemical reactions, impacting their effectiveness.
Microbial Growth:
Excess moisture creates a breeding ground for harmful microorganisms, compromising product purity and accuracy.
Processing Issues:
Moisture can cause materials to become resistant during processing, hindering tasks like grinding and pulverizing.
Additionally, it can lead to clumping and uneven coating of tablets, resulting in substandard products.
Must read article: AHUs, Air Types, Air Changes and their Functions in Pharma Industry
New-Generation Air Solutions: Addressing the Moisture Menace
To comply with the revised Schedule M and ensure top-notch product quality, pharmaceutical companies are turning to advanced air quality control technologies:
Dehumidification Systems:
These solutions meticulously monitor and regulate humidity levels throughout the entire production lifecycle – from processing and manufacturing to storage, research, testing, and packaging.
Maintaining optimal humidity safeguards medication quality and efficacy throughout its shelf life.
Desiccant Dehumidifiers:
These high-performance dehumidifiers can achieve extremely low relative humidity (RH) levels, as low as 1% or even lower.
This creates the ideal environment for manufacturing highly sensitive pharmaceutical products.
Benefits of New-Generation Air Solutions
Enhanced Product Quality and Safety:
By controlling moisture, these solutions significantly reduce the risk of product degradation and contamination, ensuring safe and effective medications.
Compliance with Evolving Standards:
These technologies help pharmaceutical companies meet the latest GMP regulations, aligning their manufacturing processes with international best practices.
Sustainable Manufacturing:
Energy-efficient dehumidifiers are becoming increasingly popular, promoting energy conservation and a more sustainable manufacturing process.
Reduced Downtime and Cost Savings:
New-age dehumidifiers minimize production downtime, leading to cost-effective pharmaceutical production without compromising quality.
Conclusion
The Indian pharmaceutical industry’s commitment to quality and compliance is evident in its embrace of new-generation air solutions.
By implementing these advanced technologies, pharmaceutical companies can ensure their products meet the stringent standards outlined in the revised Schedule M, solidifying their position as global leaders in the pharmaceutical sector.
Key Notes on Revised Schedule M: Must read
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
New R&D Policy Ushers in Era of Collaboration and Efficiency
Govt Job: For Pharmacists under Public Service Commission
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