The execution of 21 CFR Part 11 might look costly as well as might require a lot of work, but this has definitely standardised the process for electronic records.An insight by Pooja Patil, Corporate Communications, B&R Industrial Automation.
EVERYONE IN in the pharmaceutical industry is well aware of the stringent laws and standards being set by the US Food and Drug Administration (FDA). The US FDA is responsible for the safety and efficacy of medicines and food products. It has comprehensive laws and regulations for pharma manufacturing practices to ensure quality, purity and safety for individuals. Sometimes, the smallest deviation from standards can result in entire batches being rejected or recalled after they are out in the market. In grave circumstances, a company’s license could be at stake.
Compliance with standards, allows pharma companies to enhance product quality and meet standards. All these stringent requirements, task pharma companies across the globe to examine data at every stage of the manufacturing process, right from the time raw material arrives until the final product is packed and shipped for distribution. In many ways, data quality is extra important for pharma companies. After all, mistakes in this industry can literally be fatal. In traditional pharma facilities, the references and information about drug formulation, production and equipment and data of QA-QC were manually entered in data sheets, which were prone to human errors or could stand a chance of manipulation. The pharma industry needs accurate and reliable data to ensure safety, efficacy and quality of products. FDA has answered these challenges with 21 CFR Part 11 regulations.
Benefits of 21 CFR Part 11
Bu hikaye Express Pharma dergisinin Express Pharma (Vol.13, No.14) May 16-30, 2018 sayısından alınmıştır.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber ? Giriş Yap
Bu hikaye Express Pharma dergisinin Express Pharma (Vol.13, No.14) May 16-30, 2018 sayısından alınmıştır.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber? Giriş Yap
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