CLOSE

Specials

I agree We use cookies on this website to enhance your user experience. By clicking any link on this page you are giving your consent for us to set cookies. More info

Skip to: Curated Story Group 1
lifesciencesreview
US
EUROPE
APAC
LATAM
  • Home
  • Contributors
  • News
  • Conferences
  • Newsletter
  • Whitepapers
  • Magazine
  • About
×
#

Life Science Review Weekly Brief

Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Life Science Review

Subscribe

loading

Thank you for Subscribing to Life Science Review Weekly Brief

  • Home
  • News

Recommended picks

A Brief Overview Of Green Biotechnology Tools And Applications

A Brief Overview Of Green...

Key Advantages of Agtech in Farming

Key Advantages of Agtech in Farming

Different Fields of Agriculture Implementing Biotechnology

Different Fields of Agriculture...

Nanotechnologys Impact on Environment: What to Know

Nanotechnologys Impact on...

How Automation in Pharmaceutical is Giving a New Direction to Drug Development

How Automation in Pharmaceutical is...

Ways Health Economics and Outcomes Research can Improve Decision Making Process

Ways Health Economics and Outcomes...

Top Agtech Industry Trends to Keep an Eye on

Top Agtech Industry Trends to Keep an...

Strategies to Mitigate Life Sciences Supply Chain Challenges

Strategies to Mitigate Life Sciences...

A Brief Overview Of Green Biotechnology Tools And Applications

A Brief Overview Of Green...

Key Advantages of Agtech in Farming

Key Advantages of Agtech in Farming

Different Fields of Agriculture Implementing Biotechnology

Different Fields of Agriculture...

Nanotechnologys Impact on Environment: What to Know

Nanotechnologys Impact on...

How Automation in Pharmaceutical is Giving a New Direction to Drug Development

How Automation in Pharmaceutical is...

Ways Health Economics and Outcomes Research can Improve Decision Making Process

Ways Health Economics and Outcomes...

Top Agtech Industry Trends to Keep an Eye on

Top Agtech Industry Trends to Keep an...

Strategies to Mitigate Life Sciences Supply Chain Challenges

Strategies to Mitigate Life Sciences...

What is the Role of Technology in Solving FDA Compliance Challenges?

Life Sciences Review | Friday, October 30, 2020
Tweet

One of the biggest threats to the growth story of the Indian Pharmaceutical Industry today is non-compliance.


Fremont, CA: The cost of a single non-compliance event is tens of million dollars and does not include the loss of market capitalization and reputation. Since 2000, drug manufacturers have lost more than USD 3 billion for drug safety violations. The reason behind non-compliance is quite diverse and spread throughout people, process, and technology. Compliance is an evolving domain, and pharma companies have been prolonged to adapt to any major changes in regulations.


Here are some emerging trends in non-compliance.


Data Integrity


Fifteen years ago, when FDA started issuing warning letters for data integrity warning letters for identified failures in computer system validation, failure to review the laboratory computer systems audit trails, failure to maintain the electronic records, and failure to investigate their disappearance — the volume of warning letters containing a violation of data integrity have grown to 80 percent of all letters issued.


Cross Contamination


Cross-contamination has been one of the most debated compliance topics in the past few years. 


The industry is slowly adopting HBELs (Health-Based Exposure Limits) since EMA (European Medicines Agency) had published its Guideline on setting the health-based exposure limits for use in the risk identification in the manufacture of various medicinal products in shared facilities. Regulators are looking not only for science-based cleaning acceptance limits but also for the Statistics based alert limits keeping cleaning process capability in mind.


Release Testing


Releasing a drug product without a good assessment of the drug product’s quality leads to this kind of issue in the warning letter. Nearly one-fifth of all compliance issues are because of the incorrect or immature release of the product.


Slow Adoption of Technology in Pharmaceuticals


Conventionally, the Pharma industry has been very slow in adopting newer technologies compared to some of the other manufacturing industries like oil & gas, mining, and automobiles. This is usually attributed to the industry’s regulated nature and a lack of strong IT leadership.


Most production and compliance systems are still paper-based and suboptimal. As per a survey, 90 percent of the drug production facilities don’t use any computerized systems for compliance management.


See also: Top Healthcare Compliance Solution Companies


Weekly Brief

loading
Towards a New World Order
> <
  • DNA Sequencing 2022

    Top Vendors

    Current Issue
  • BioTech Startups 2022

    Top Vendors

    Current Issue
  • DNA Sequencing 2022

    Top Vendors

    Current Issue
  • BioTech Startups 2022

    Top Vendors

    Current Issue

Read Also

Role of Predictive Genomics in Sustainable Healthcare

Role of Predictive Genomics in Sustainable Healthcare

A Conversational AI Approach to Regulatory Intelligence

A Conversational AI Approach to Regulatory Intelligence

A rise in DNA Sequencing Market is expected in coming years

A rise in DNA Sequencing Market is expected in coming years

Omniabio Inc. Announces Private Investor

Omniabio Inc. Announces Private Investor
Data analysis for next-generation sequencing worth USD1.2 billion by 2026 - Cloud-based platforms emerging as preferred solutions

Data analysis for next-generation sequencing worth USD1.2 billion by 2026 - Cloud-based platforms emerging as preferred solutions

Lithuania's Vision to Become a Biotech Hub in Europe

Lithuania's Vision to Become a Biotech Hub in Europe

Bridging the Diversity Gap in Genomics

Bridging the Diversity Gap in Genomics

How does Biotechnology Provide Solutions to Human Needs?

How does Biotechnology Provide Solutions to Human Needs?
Loading...

Copyright © 2022 Life Science Review . All rights reserved. |  Subscribe |  About Us follow on linkedin

This content is copyright protected

However, if you would like to share the information in this article, you may use the link below:

https://www.lifesciencesreview.com/news/what-is-the-role-of-technology-in-solving-fda-compliance-challenges-nwid-159.html