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
Denne historien er fra May 16, 2017-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
Denne historien er fra May 16, 2017-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
Blissfill-Calibrated syringe pipettes for repetitive laboratory dosing as per ISO 8655-9
Blissfill syringe pipettes provide laboratories with an ergonomic, self-refilling solution for repetitive dosing, delivering precise volumes from 0.05ml to 10ml. With ISO 8655-9 compliance and an included calibration certificate, Blissfill ensures accuracy and ease of use for high-demand lab applications
Ensuring pharma compliance with testo data measurement technology
Comprehensive data measurement tools address regulatory demands and secure quality in pharma
Waters launches software for lab-centric business intelligence enabling audit readiness
waters_connect Data Intelligence software provides laboratories with comprehensive business intelligence on their chromatographic data throughout the product development lifecycle, enabling real-time audit readiness and query response, while reducing time spent on audit preparation
Ensuring clean room integrity with Prime Clean Reset High-Speed Doors
Designed with precision to meet the stringent requirements of controlled environments, Prime Clean Reset is the epitome of performance and reliability, ensuring that your clean room operations consistently meet the highest standards of regulatory compliance and product integrity
Optimising efficiency with Remote Laboratory Solutions
LabWare's comprehensive suite of software solutions designed specifically for laboratories offers reliable Remote Laboratory Solutions to help your business thrive in the current climate
Ensuring water quality with the 6000TOCi: The ultimate solution for continuous TOC measurement
The 6000TOCi Sensor is a comprehensive solution that brings together continuous monitoring, rapid response, reliability, and compliance
Enhancing pharmaceutical analysis in critical areas
Dheeraj Handique, Manager GC/GCMS Product Marketing, Shimadzu Analytical (India) highlights the benefits of GCMS-TQ8050 NX with HS-20 NX trap for genotoxic impurities, nitrosamines, and, extractables and leachables
Technical innovations for Annex 1
To meet the stringent EU GMP Annex 1 requirements, Optima presents innovative solutions to improve product and patient safety in pharmaceutical manufacturing. From minimising glove interventions and optimising First Air flow to advanced automation for integrity testing, this article explores how Optima's technologies support compliance in aseptic fill-and-finish processes
JRS Pharma - The Global MCC Manufacturing Network
JRS Pharma is one of the largest manufacturers of MCC across the globe. The know-how is based on more than 25 years of experience in development of own processes
Mack Pharmatech is the first to launch PLC-based environmental chambers in India
Manoj Choudhari, Managing Director, Mack Pharmatech shares insights on his company's pioneering expand globally and enhance regulatory compliance
