Implementing cGMP quality systems and risk management approaches

[Adam Fleming]

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