Indian pharmaceutical industry is adapting to the revised Schedule M guidelines by considering the deployment of new-generation quality air solutions. This is because air moisture is a critical factor in pharmaceutical manufacturing processes, as it can affect the quality and stability of medications.
By implementing advanced air quality control measures, like humidity control systems and air purification technologies, pharmaceutical companies ensure their manufacturing environments meet the stringent standards set by the revised Schedule M.
This proactive approach not only enhances product quality and safety but also demonstrates a commitment to compliance and innovation within the industry. The recent revision in Good Manufacturing Practices (GMP) bodes well for the Indian pharmaceutical sector, said Deepak Pahwa, chairman, Pahwa Group and managing director, Bry-Air.
The industry a significant player in the international market, exporting medicines to over 200 countries. It is all the more important to uphold the quality of pharma products that is at par with international standards. To achieve, revised GMP has been introduced to elevate the medicine quality, enabling the country to reinforce its reputation and further strengthen its foothold in the international market, he added.
In the pursuit, quality air solutions play a crucial role in abiding by the GMP regulations. It significantly enhances the quality and maintains the safety of pharmaceutical products. Employing quality air solutions goes a long way towards checking the moisture menace in the pharmaceutical industry. Moisture is responsible for deteriorating the quality of pharmaceutical products by initiating organic corrosion, accounting for biochemical reactions. It promotes the germination of unwanted microorganisms that interferes with product accuracy, he pointed out.
Along with this, in the presence of moisture, materials become resilient in the processing phase and defy grinding and pulverizing operations. Moisture causes lumping and caking of powder at the time of tablet compression and also gives rise to a rough, translucent tablet coating. Therefore, moisture accounting for substandard pharmaceutical products, it is essential to supply moisture-free air devoid of any form of contamination to efficiently comply with Good Manufacturing Practices outlined for the industry, he said.
Moisture can severely degrade the quality of pharmaceutical products. It can lead to the revocation of products from the market and significantly mar the growth prospects of the sector while impacting its reputation in the international market. To address the moisture menace, dehumidification solutions closely monitor the environment throughout the processing, manufacturing, storage, research, testing, and packaging of pharmaceutical products. It maintains the humidity level within safe limits to ensure the quality of medicine throughout the shelf-life of the product. Along the similar line, industry players can employ desiccant dehumidifiers that come with the proficiency to achieve a constant RH as low as 1% or even lower throughout the manufacturing of pharmaceutical products, Pahwa told Pharmabiz.
By alleviating the moisture woes, dehumidifiers play a crucial role in retaining the potency of the medicines and upholding the efficacy of the products, which otherwise are compromised in the presence of moisture. As a result, dehumidification solutions aid in complying with the evolving manufacturing standards that are in alignment with global requirements.
To drive maximum output in the pharma industry, leading players are nowadays seeking energy-efficient dehumidification solutions. It goes a long way in energy conservation and at the same time bodes well for ensuring the sustainability of the manufacturing process. The new-age dehumidifier significantly reduces the downtime of the manufacturing units, ultimately accounting for cost-effective pharmaceutical products while not compromising the quality of the products, said Pahwa.
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