SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and Director - Global Strategy (Technical), Micro Labs, emphasises the need to adopt a Quality Management Systems (QMS)-based approach to provide quality medicines
Revisiting the question posed in myarticle 'Pharmaceutical qualityand compliance: Has the 'elephant in the boardroom’ been recognised' in Express Pharma GMP special issue of May 2016, it appears that we have embarked on the quality journey and the industry seems to have corrected its skewed perception related to GMPs. It has recognised the need to go beyond mere ticking the boxes for demonstrating compliance with minimum regulatory standards to adopting a Quality Management Systems (QMS)-based approach and positioning quality as a management function for providing high quality medicines.
A myriad of initiatives have been started by the industry and associations that demonstrate a paradigm shift in the approach towards quality and compliance. The focus clearly seems to be on skill upgradation and capacity building. The IPA Quality Forum is working tobring the large companies together to address quality issues and to jointly develop solutions based on global best practices with a view to help Indian pharma manufacturers to achieve global benchmark in quality. Similarly, the Department of Pharmaceutical (DoP), Ministry of Chemicals & Fertilizers has initiated a nationwide GMP training programme in partnership with IDMA for helping the industry to voluntarily upgrade GMP standards to current global standards. One of the major policy initiatives of Government of India of recent times has been the Prime Minister's Skill India initiative implemented through Life Sciences Sector Skill Development Council (LSSSDC) in pharma industry.
Despite these initiatives, the industry still confronts operational challenges for ensuring ongoing GMP compliance and in implementing successful remediation measures. The common factor in both the cases seems to be lack of adequate skills of personnel in these functions as seen from the observations below.
Consistently inconsistent GMP Compliance- A recurring issue
This story is from the {{IssueName}} edition of {{MagazineName}}.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber ? Sign In
This story is from the {{IssueName}} edition of {{MagazineName}}.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber? Sign In
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
Reshaping pharma safety with active packaging innovations
CILICANT is revolutionising active packaging with solutions tailored for the most sensitive formulations. Meet the innovators driving stability, safety, and impurity control in pharma packaging at CPhI India
UNLOCKING GROWTH FRONTIERS
Vadodara Pharma Summit 2024 brought together industry leaders and experts to highlight the city's pivotal role in India's pharma landscape and explore collaborative strategies to strengthen India's pharma innovation ecosystem
Optimising cloud provisioning for pharmaceutical compliance and operational excellence
Suresh Perikala, Senior Engineering Lead - DevOps and Cloud Engineering Practice, Altimetrik
Accelerating pharma's sustainability efforts
Avinaw Prasad, Director, Climate Change & Sustainability, Deloitte India explains why integrating sustainability into the core pharma business strategy is essential for long-term success, analyses key focus areas and policy pushes which can incentivise companies to further evolve on the sustainability path
Drug Repurposing: Unlocking access to rare solutions
Drug repurposing, a quick, cost-effective path to deliver existing treatments to patients, can serve to expedite and expand healthcare access for patients with rare diseases
Optimising spend, maximising growth
Express Pharma, in partnership with IPA and CHEMEXCIL, powered by SAP, recently organised a thought leadership conclave on 'Reimagining spend management and supply chain' where cross functional experts explored strategies to drive value through supply chain transformation
