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 In a strategic push towards strengthening pharmaceutical manufacturing standards, the Gujarat Food and Drug Control Administration (FDCA) has successfully trained and urged approximately 900 micro, small, and medium enterprises (MSMEs) to submit need gap analysis documentation through the Central Drugs Standard Control Organization’s (CDSCO) Online National Drug Licensing System (ONDLS). This initiative comes as part of the broader compliance mandate under the revised Schedule M of the Drugs and Cosmetics Rules, focusing on Good Manufacturing Practices (GMP).
Announced by FDCA Commissioner Dr H G Koshia, the campaign is part of an extensive regulatory initiative to bring MSMEs, particularly those with annual turnovers below Rs. 250 crore, in line with the December 31, 2025 deadline set for implementing revised GMP norms. Gujarat is home to over 3,200 allopathic drug manufacturers, of which around 900 are categorized as MSMEs, and 400 are large, organized pharma players.
“We’ve launched a series of capacity-building training sessions involving regulators, manufacturers, and industry stakeholders to ensure effective implementation of revised Schedule M. A critical part of this involves understanding and integrating cleanroom protocols, specifically the deployment of Personnel Air Locks (PALs) and Material Air Locks (MALs), in the manufacturing process,” informed Dr. Koshia.
The revised Schedule M emphasizes rigorous control of manufacturing environments through advanced cleanroom practices. PALs and MALs are essential airlock systems designed to uphold the integrity and hygiene of cleanrooms facilities, which is critical to pharmaceutical production.
PALs are enclosed buffer zones used by personnel transitioning into and out of cleanroom zones. Their function is to minimize the risk of human-borne contaminants entering high-sterility environments.
MALs serve a parallel function for materials—ensuring that raw inputs, packaging, and finished products can be moved across zones without compromising environmental controls.
According to GMP standards, airlocks act as barriers between cleanroom classifications—typically ranging from Class A (most sterile) to Class D (less controlled)—and are vital to preventing cross-contamination.
Proper implementation of PALs and MALs is a foundational requirement in GMP-compliant facility design. Key considerations in designing cleanrooms under Schedule M include flush design and seamless finish to reduce microbial buildup and facilitate cleaning, environmental and microbiological monitoring through routine checks to ensure that the cleanroom performance stays within required limits.
HVAC Systems are critical for maintaining pressure differentials and air cleanliness. Sinks, drains, and interlocking doors are designed to avoid reverse contamination and ensure process integrity. Operational Modes to differentiate between 'at rest' and 'in operation' conditions to validate room classifications.
Types of airlock configurations such as Cascade, Bubble, and Sink may also be deployed depending on the specific needs of sterile manufacturing, including vaccine production, biologics, and emerging sectors like cell and gene therapy.
“The Gujarat FDCA’s training initiative is aimed at equipping manufacturers with the technical and operational understanding needed to transition into a globally competitive manufacturing framework. With the regulatory deadline approaching in December 2025, the focus remains on collaborative training, system integration via ONDLS, and robust industry-government engagement,” Dr. Koshia concluded.
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