Online Safety Community

cGMP Data Integrity is of Critical Importance

Of late, the FDA has been turning on the heat on manufacturers in the FDA-regulated industries that violate its regulations. It has a penchant for going after manufacturing facilities that show laxity in implementing current Good Manufacturing Practices (cGMP). This ardor is understandable. cGMP violations affect the quality of the product; hence the strictness, considering that it is patients who consume these products.

internal_audit_pichet_1524848489489

There are ways of ensuring that the product meets the acute scientific requirements set out for it at all stages, from the beginning till the end. Data integrity is the most important of these. As the term suggests, data integrity is the assurance that there is complete accuracy, security, reliability and completeness of the records relating to the product and its processes.

Data integrity comes about by tightening cGMP requirements

In the FDA’s line of thinking, the way of ensuring uncompromising quality of a product is by tightening its laws on cGMP and implementing them. The FDA believes that only extremely stringent actions on its part help manufacturers meet regulatory requirements and give patients the assurance that the products they use meet quality standards.

Among the many mechanisms that the FDA has undertaken towards ensuring this, requirements relating to data integrity rank high. Data integrity is critical to ensure the quality, safety, and efficacy of products in the FDA-regulated industries. These include biologics, pharmaceuticals, life sciences and medical devices, among others.

What happens when there is no data integrity?

Issues relating to data integrity have been high on the list of items that the FDA finds out during its inspections. When companies fail to meet the FDA’s data integrity expectations and requirements; data integrity is compromised. When this happens, many batches of finished goods that do not comply with regulatory authorization terms get manufactured. The FDA prohibits such lots and batches for release for sale.

Lack of data integrity is viewed very seriously by the FDA. It considers this as falsification or breach of data and passes heavy strictures on such companies. It initiates a series of penal actions on such companies after comprehensive investigations show lack of data integrity. These are some of the FDA actions that could accrue from data integrity breach:

Another additional enforcement action that could result from this scenario is carrying out a full risk assessment to establish the potential of the data integrity-deficient drug to cause problems for patients who consume their products. And then, the FDA could also suggest management actions that seek to correct the issues arising out of data integrity breach.

Complete understanding of data integrity

A look at the grave consequences arising out of the inability to meet the FDA’s requirements on data integrity points to the absolute need for organizations in any FDA-regulated industry to get a complete grasp of all aspects of data integrity, which will help it to avoid FDA citations. This learning will be imparted at a valuable webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

Data-Integrity 123486484084

 

Danielle DeLucy, who owns ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance, will be the speaker at this webinar. Want to hear from her on how to implement steps for ensuring data integrity? Then, please enroll for this webinar by visiting Management of GMP Data Integrity

Total grasp of cGMP requirements on data integrity

21 CFR Part 11 is only a part of data integrity and security breaches. Data integrity and security breaches can also involve severe cGMP violations. This webinar’s speaker will analyze these and offer information about practices that the participants can review and implement at their own site and identify gaps in their practices. The importance of data integrity in assuring the quality of raw materials, in-process materials and finished goods in the cGMP for FDA-regulated industries will be explained.

These areas will be covered at this webinar:

  • Discover the Criteria for Data Integrity
  • Recognize what needs to be addressed to ensure Data Integrity within a regulated GxP Laboratory
  • Learn about approaches to improve Data Integrity in a Laboratory Environment.

Professionals in the regulated industries, such as Site Quality Operations Managers, Quality Assurance Personnel, Plant Managers and Supervisors, Manufacturing Superintendents and Managers and Regulatory Affairs Managers will find this webinar on implementation and management of cGMP data integrity highly worthwhile.

Views: 10

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Jam Blanco posted blog posts
1 hour ago
Bigclasses online training posted an event
Thumbnail

Become an SAP FICO Consultant- Learn SAP FICO from Experts at online

January 17, 2018 from 8am to 8pm
Learn SAP FICO from BigClasses. Now get the course only at Rs. 5310/-…. Hurry Up and Contact Now!!!BigClasses is a reputed and most trustworthy Online Training provider India. Students from USA, UK, Canada, Germany, Singapore and more has studied the professional IT courses from BigClasses. We have taught more than 5000 students over 10 years. Our Trainers are well-experienced and trained with the latest trends and technologies in the field.Trainers at BigClasses will prepare you with revised…See More
2 hours ago
Harris Scott posted blog posts
6 hours ago
Adam Fleaming posted a blog post

EDITORIAL – Conor O’Dea: A coup for Cayman Finance

A standard disclaimer in investment literature warns that “past performance is not indicative of future results.” But in the case of Conor O’Dea, the financial services veteran recently selected as chairman of Cayman Finance, a waiver of that warning would be perfectly appropriate.Mr. O’Dea’s sterling professional track record, decades in the making, gives us confidence in his ability to lead Cayman Finance, along with CEO Jude Scott, to new altitudes of success.The new Cayman Finance chairman…See More
7 hours ago

Forum

What's your favorite motivational/safety quote? 103 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by Lissa on Thursday.

Python Online Training by QA Training Hub

QA Training Hub is best Python Programing Online Training Center in India. Python Online Training provided by real time working Professional Mr. Dinesh. Data Scientist and RPA Expert  with 18+ years…Continue

Tags: Bangalore, delhi, Hyderabad, best, institute

Started by sonyagarwal Jan 3.

Business Intelligence with Big Data happens at Unipê 1 Reply

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri. Last reply by Manchun Jan 2.

VMware player error on install vmware tools. 1 Reply

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa. Last reply by Manchun Jan 2.

Forklift Training in Calgary

Do you wish to learn forklift driving? A forklift is a type of industrial vehicle that firstly lift the material and then transport it. The forklift machine is capable of lifting heavy loads by…Continue

Started by Gurjinderpal Sandhu Dec 27, 2017.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service