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: 9

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

Silvia Watson posted a blog post

How Can Crossfit Training Keep You Healthy and Fit?

CrossFit is the best way to keep your body active, your mind intrigued and your system alive. This is a high-intensity workout routine that involves strength building, muscle building and weight training activities along with intense aerobic workouts. People who indulge in CrossFitting at least once in a week are faster, nimbler and retain top shape throughout the workout time span.…See More
18 hours ago
John Robinson posted a blog post

Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses…See More
Friday
Adam Fleaming posted blog posts
Friday
Alex posted a blog post

3 essential electrical safety tips for new students

Living away from home for the first time is an exciting, invigorating, and pretty daunting experience. While your first days at uni will be the time of your life, living away from your parents also comes with a new set of challenges.Aside from cooking and cleaning, one thing we take for granted is our parents’ knowledge of how to keep us safe. Electrical safety, in particular, is something not many first-time students know a lot about, but electrical accidents are…See More
Friday

Forum

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe on Thursday.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells on Wednesday.

What's your favorite motivational/safety quote? 102 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 David Collins on Tuesday.

Business Intelligence with Big Data happens at Unipê

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 Nov 1.

Road Safety Solutions 13 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Barry Oct 26.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service