GMP Compliance Basis Blog

a Q8 QbD page has been added to the main GMP CB site with a simple explanation of the Design Space concept…

This is a very simple explanation and discussion…if you get the chance, go to a real seminar for a more in depth discussion…but if you’re looking for simple, feel free to check it out…

The people I know who have worked successfully in a GMP environment share one consistent characteristic… 

It’s not that they all share the same understanding of the regulations…I have heard endless debates about differing interpretations…  It’s not that they had better document templates than other companies…they struggled to get their documents together just everyone else… 

It’s not that they haven’t dealt with operational issues, they’ve had as many struggles as anyone else… 

I think the most significant single issue is that when they sign their name, they understand they are taking responsibility for compliance with federal regulations and everything that that implies…they take compliance very personally, that they feel a real sense of personal accountability and responsibility for compliance… this willingness to take personal responsibility is what sets them apart… 

If your organization has GMP compliance issues, I bet your corporate culture has problems with accountability or responsibility…if your corporation has problems with accountability and responsibility, you may also have GMP issues… 

Practical Applications

Joint ISPE/ PDA Seminar addressing Q8 & Q9 Guidances…

Benefits of attending:

• Become aware of the process and interactions in the development of the Q8 and Q9 Guidances
• Recognize the benefits of Q8 and Q9 implementation
• Hear the concepts surrounding regulatory flexibility based on relevant scientific knowledge from leading subject matter experts
• Learn how the concept of design space impacts regulatory assessment and approval of a product
• Apply the concepts and principles contained in the Q8/Q9 Guidance documents to your company’s manufacturing and R&D practices
• Network with your peers to learn how the Guidances are being implemented by regulators and industry in the three ICH regions
• Determine future needs for a long term vision related to Q8/Q9 implementation
• Learn how to assure development of a quality product over the product life cycle from pre-clinical to post-marketing

Learning Objectives

At the completion of this Conference, participants will be able to:

• Explain the thinking that went into the development of the Guidances
• Apply the concepts and principles contained in the Q8/Q9 Guidance documents to their company’s manufacturing and R&D practices
• Identify challenges and mitigate risks associated with pharmaceutical manufacturing and development
• Differentiate regional obstacles to implementation

I was talking to Chad the other day, and, as usual, he had lots of good ideas going…

Among other things, he mentioned a “GMP Toolbox”…he did follow up by saying that having the tools is not enough if you don’t know how to use them correctly…we all have some basic tools in the basement, but how many of us can build furniture?

So what would be in a GMP Toolbox?

What would be in a Project Manager’s Toolbox?