Improve GMP-WHO to GMP-EU

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi, all. My company is preparing to upgrade GMP-WHO to GMP-EU. But I have a little knowledge about GMP- EU (just basic, because I have read Eu-dralex GMP vol 4, recently). So I need some experiment of all friends in forum. Please share me some experiment to build a quality system comply with GMP-EU.

Thank you very much

2

Hi, I will be glad to help you.You can write a question especially what you want to know or do.

3

Hi @haipharma92

I think our online course on cGMP would be a great starting point as it explains in detail the differences here.

Use this link to see the course overview:
http://learnaboutgmp.com/elearning/good-manufacturing-practices-cgmp/

Regards

1 Like
4

Thank you very much, I know to comply with GMP-EU very difficult. So can you tell me how to build Quality System to control (you can share some document to do that) ?
What common fault should I avoid when inspection ?

5

ICH Q10, discusses all the various quality systems (there are quite a few, which Graham O’Keeffe highlights in his link)

Here is a recent guideline from the international commettee for harmonization
http://www.ich.org/products/guidelines/quality/quality-single/article/pharmaceutical-quality-system.html

Here is how various agencies have adopted the guideline:
EU: ICH Q10 Pharmaceutical quality system - Scientific guideline | European Medicines Agency
FDA: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073517.pdf

Here is another quality system guide (from ISO), which is accepted pretty universally, although some countries don’t exactly adhere to it, but which is very good also.

Again, this is a rather big undertaking, which can take months/years to set up for the various quality systems. Depending on where you are (research, clinical manufacturing, commercial manufacturing) you would have to focus on some quality systems first. What industry are you in?

But to answer your question overall, about how to set up a quality system you will need do the following
Create a flow diagram. Include how things will flow through the process, and how to handle deviations. Make sure you discuss who is doing what, and how they document/sign things. The flow of information is critical, to ensure the correct information is generated, presented, discussed, approved, and then stored. All the processes need to have an documented operating procedure (SOP), with forms or an electronic system to record the information/decisions/approvals.

Please feel free to ask more questions, as this is just the tip of the iceberg.

2 Likes