Amit Rajan, Managing Director, Prosfora Technologies, says that instilling a culture of compliance in a pharma set up is about nurturing, training and development of all the staffs concerned, on a continuous basis. It’s also about nurturing and inculcating an important cultural attribute, the need for being honest
The term Good Manufacturing Practice (GMP), implies the standards or good practices followed in core manufacturing of any item or product. However, it encompasses a broad spectrum of activity starting from testing, manufacturing, labelling and stability studies when used in the context of pharma products, interchangeably called as drugs or medicines.
The pharma business is an extremely regulated one which the manufacturers have to comply in letter and spirit. These regulations have been codified in form of laws or guidances published from time to time by various pharma regulatory agencies across the globe. Compliance to the GMP code laid out, have, thus become a key rallying point between the pharma manufacturers and the regulators worldwide in recent days.
Significant violation to GMP was noticed at your manufacturing unit based at……...
Numerous observations were made which were non compliance to the GMP requirements of 21 CFR part 210 &211 at your drug product site located at …….
Denne historien er fra April 16-30, 2019-utgaven av Express Pharma.
Start din 7-dagers gratis prøveperiode på Magzter GOLD for å få tilgang til tusenvis av utvalgte premiumhistorier og 9000+ magasiner og aviser.
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Denne historien er fra April 16-30, 2019-utgaven av Express Pharma.
Start din 7-dagers gratis prøveperiode på Magzter GOLD for å få tilgang til tusenvis av utvalgte premiumhistorier og 9000+ magasiner og aviser.
Allerede abonnent? Logg på
Nutraceutical M&As: How strategic mergers are shaping the health and wellness market
The nutraceutical industry has seen a surge in M&A activity over the past three years as companies pursue strategic acquisitions to strengthen market positions, diversify offerings, and drive innovation. Sudhindran N, GM - Corporate Affairs, Nutrify Today explores key trends, motivations, notable deals, and future growth prospects shaping the industry
Rising research costs, complex drug systems, stringent regulations, and global pressures pose major threats to pharma R&D
According to one of the published reports, the pharma industry invested about $83 billion in R&D in 2019, which is about 10 times the research and development (R&D) spent per year in the 1980s, after adjusting for the effects of inflation.
Harnessing data analytics to propel drug discovery and development in 2025
As the pharma landscape evolves, data analytics will be at the forefront of drug discovery and development, transforming traditional methods. By leveraging data-driven insights, companies can expedite R&D, optimise clinical trials, and personalise treatments, bringing life-saving therapies to market more efficiently, explains Biju Davis, SVP, Engineering, Model N
Strengthening our presence within APAC through increased penetration is a key focus
Aanchal Tomar, Executive Director, Asia Pacific, Lonza Capsules Health Ingredients speaks about Lonza Capsules Health Ingredients’ strategic growth, challenges, and sustainability initiatives in the APAC market, showcasing their innovative capsule solutions and health ingredients that cater to the region's diverse pharmaceutical and nutraceutical needs, in an interview with Express Pharma
Responsible Sourcing and Manufacturing: Growing towards a sustainable future with Lonza
In response to the establishment of environmental impact targets by the pharmaceutical industry, Lonza promotes responsible sourcing practices, sustainable manufacturing standards, and renewable energy utilisation showcasing that responsible manufacturing can assist our customers to reach their sustainability goals, highlights Christine Lebeault, Head of Applied Sustainability, Lonza Capsules and Health Ingredients
Rethinking R&D to balance efficiency, innovation and sustainability
In an era of skyrocketing research costs and complex drug delivery challenges, pharma industry leaders share their insights on adopting advanced technologies, data-driven decision-making, and sustainable practices to optimise R&D and drive impactful therapies to market
Powerful Process Control with IND500x Weighing Indicators
Ensuring consistent quality in hazardous environments, particularly in Ex-Areas (Zone 1/21, Division 1), is a critical aspect of industrial operations. The IND500x weighing indicators from METTLER TOLEDO provide a robust solution for these challenging settings, offering optimized safety and productivity.
Ensuring clean room integrity with prime clean reset high-speed doors
Prime Clean Reset high-speed doors ensure airtight seals, minimising air permeability and contamination in clean rooms. Designed for sensitive environments, they enhance operational efficiency and meet rigorous regulatory standards, making them ideal for pharmaceutical and biotech industries
Complete environmental monitoring solution - testo Saveris Pharma
There are several critical applications in the industry like research and development that demand for continuous & reliable monitoring of important environmental parameters.
Adaptive Manufacturing:-The new flexibility in medical device assembly
Unlike traditional, rigid production lines, B&R's adaptive machines seamlessly adjust to the requirements of each device, dynamically adapting to each unique process
