|
GMP endorses excellence and integrity in pharma production: Kaushik Desai
|
|
Nandita Vijayasimha, Bengaluru
October 30 , 2025
|
|
|
Good manufacturing practices (GMP) are non-negotiable standards that guarantee the pharmaceutical industry produces only the highest-quality, safest, and most effective medicines. By strictly adhering to GMP, manufacturers can eliminate risks, prevent contamination, and ensure compliance with global regulations.
GMP is not merely a set of guidelines, but is the foundation on which public health and the integrity of the pharmaceutical industry stand, said Kaushik Desai, Executive Committee Member, Industry Pharmacy Section of International Pharmaceutical Federation (FIP) and a pharma consultant.
This is even as the revised Schedule M continues to tighten regulatory frameworks, demanding stricter compliance. The updated guidelines emphasize more rigorous quality control, improved sanitation practices, and enhanced documentation to ensure absolute traceability of every medicine batch produced. These revisions aim to align with international best practices, further elevating India's pharmaceutical manufacturing standards. As a result, companies must not only meet existing requirements but also stay ahead of evolving regulatory expectations to maintain competitiveness and safeguard public health, Desai added while addressing as the chief guest and featured speaker for Manipal College of Pharmaceutical Sciences, first Pharma Industry Summit 2025 here recently.
Noting that GMP is the cornerstone for the pharmaceutical industry for decades as it helped India ensure that every medicine produced meets stringent standards for quality, Desai said, “Today, we stand at the threshold of a new era in pharmaceutical manufacturing, shaped by rapid digitalization and unprecedented technological innovation”.
With the integration of advanced technologies such as automation, artificial intelligence, real-time analytics, and digital recordkeeping, GMP is experiencing a profound transformation. From preventive maintenance to real time monitoring, digital technologies are transforming the GMP landscape. These advancements not only streamline processes and enhance productivity but also foster a culture of compliance and transparency, he pointed out.
At the same time, evolving global health demands and regulatory standards present both opportunities and challenges for industry professionals. The shift toward digital GMP means adapting to new tools and mindsets, learning how to harness data for continual improvement, and staying ahead of changing expectations from health authorities worldwide, said Desai.
Exploring the latest trends and advanced technologies that are redefining GMP compliance, Desai deliberated on how these changes are influencing quality assurance and regulatory landscape.
Digital technology can empower us to research and manufacture safer, more reliable medicines to patients everywhere. MSMEs particularly in India faces challenges in implementing new technologies because of fund shortages and shortages of availability of right skills. They can start the process in phases with the ultimate objective of integrating all processes and systems. The big benefit is industry, machinery, pharma associations, regulators and the government, come on a common platform in support of digitalization and automation. There is great scope of industry-academia collaborations in imparting skills and support in developing new drug delivery systems. The revised pharmacy curriculum currently in draft stage also call to include AI and other digitalization tools and must be implemented as soon as possible before it becomes obsolete. Technology and regulations are dynamic in nature, and the students need to remain updated pointed out Desai lauding the efforts of the academia in hosting such technology-based events for the benefit of budding pharmacists.
|
|
|
|
|
|
|
|
TOPICS
|
The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
|
|
|
|
|