Online Safety Community

Implementing cGMP quality systems and risk management approaches

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement the most current and acceptable cGMP quality systems and risk management approaches so that they meet the requirements set out in the FDA’s cGMP regulations, namely 21 CFR parts 210 and 211. 

The FDA’s guidance on cGMP quality systems and risk management approaches describes an all-encompassing Quality Systems (QS) model and explains and highlights the way and extent to which the Quality model has to be consistent with the CGMP regulatory requirements for manufacturing drugs in the human, veterinary and biological categories.

FDA guidance on cGMP quality systems and risk management approaches is not mandatory

The FDA guidance on cGMP quality systems and risk management approaches also offers help to manufacturers who need to implement the Quality Systems in being in complete compliance with CFR Parts 210 and 211. However, these guidances on cGMP quality systems and risk management approaches are not obligatory or mandatory for drug manufacturers. They are not legally enforceable. Rather, like all other guidances, they are suggestive in nature and reflect the FDA’s thinking on a particular topic at a particular point of time. Although the FDA uses the word “should”, it only means something that is of a recommendatory nature.

Full compliance is expected

Even though the FDA’s cGMP quality systems and risk management approaches is not legally enforceable; that the FDA expects full compliance with its requirements is a given. Drug companies that fail to show complete compliance with the cGMP quality systems and risk management approaches are penalized. Such companies end up paying huge fines and face all sorts of issues and problems. So, it is in their best interest to show compliance with the FDA’s cGMP quality systems and risk management approaches.

A learning session on FDA guidance on cGMP quality systems and risk management approaches

The ways of implementing cGMP quality systems and risk management approaches will be the training a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. The speaker at this session is the highly acclaimed and experienced professional, Jerry Dalfors, who has for over four decades been helping drug companies in a business administration, consultative, technical and managerial role in the development and manufacture of highly regulated biopharmaceutical products.

This session on implementing cGMP quality systems and risk management approaches will guide participants on what they can do to minimize patient risk and increase ROI. The speaker will show how this is a better option compared to paying outside contractors to fix errors.

Understanding FDA guidance on cGMP quality systems and risk management approaches from two important perspectives

This learning is important from two perspectives. First, it will help participating companies learn the nitty-gritty of implementing cGMP quality systems and risk management approaches.

Second, Jerry will help a drug company that is in the business of manufacturing materials that are regulated by the respective country’s government to ensure that the design and established operations are going meet both the local regulations but also those of the places to which the product might be shipped.

Jerry will cover the following areas at this session:

CGMPs and the concepts of current quality systems, including quality by design and development, risk management, CAPA, Change Control, Management Responsibilities, Resources, Manufacturing and Evaluation Activities.

o  Terms and Definitions - with related acronyms

o  Quality Management System - Quality = Profitability and does all it can to minimize operator errors

o  Documentation Requirements - entering data, comments and making corrections

o  Management Responsibility and GMP/Quality Commitment

o  Quality Policy - General elements of the Quality Manual and Individual Training Requirements for each job description.

o  Human Resources - Individual employee files providing documented evidence of required education or experience and related training for the individual's position

o  Purchasing, Incoming Control and Raw Material Release

o  Gowning, Environmental Control and Monitoring

o  Product Testing, Inspection and Document Review for Final Product Release

o  Incident Tracking, Change Control, CAPA and Annual Quality Review

http://www.compliance4all.com/control/w_product/~product_id=501172L...

http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070337.pdf

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

David Collins posted a blog post

What is the real role of a safety advisor?

The Role of Safety Advisor in Organisations – Essential ReadingWhilst everyone wants to do ‘safety differently’, it is not likely that reform will come within. The paradigm of safety with its primary focus on measurement actually mitigates any hope of innovation, creativity or critical thinking. If safety is now the…See More
7 hours ago
Prawit is now a member of Online Safety Community
22 hours ago
Adam Fleaming posted a blog post

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as…See More
yesterday
Adam Fleaming posted a blog post

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.So, what is medical device hazard analysis? Medical device hazard analysis may be defined…See More
Monday

Forum

What's your favorite motivational/safety quote? 97 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 6 hours ago.

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V on Friday.

OSHA 500 and 510 9 Replies

Hey Guys,How many of you have taken the 510 and 500 OSHA Trainer course? I am thinking about taking these 2 classes and become an OSHA trainer for my company. What are your guys thoughts on the…Continue

Started by Alfred Good. Last reply by Mymic Mar 15.

OSHA Training, Standards & Best Practices 3 Replies

Get trained on OSHA regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best…Continue

Tags: Webinar, Training, 2011, OSHA, compliance

Started by admin. Last reply by Mymic Mar 15.

FORKLIFT TRAINING CLASSES 21 Replies

Any ideas on how to make Forklift Training Classes more interesting and fun?

Started by Marcia Whatley. Last reply by Mymic Mar 15.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service