GMP SOPs

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Radel
Radel's picture
GMP SOPs

Hello to everyone.
I am new in this forum, so if I posted wrong, please forgive me. I work for a short time in a drug manufacturing factory. The medicines we are producing are for animals. I was designated to implement GMP system in our company. But I know relatively about GMP. My first question is: does anyone have a list of SOPs to be done in such company? I know I must have SOP for everything We do, but I don't know which.Can anyone help me?Thanks.

Omai
Omai's picture
Hi Radel,

Hi Radel,
 
I don't have any personal experience, but here are links to a couple of companies that seem to specialize in what your are looking for.
www.standard-operating-procedure.com/ 
www.gmp-online-consultancy.com/
Also, in the Category Pharmacology and Drug Discovery, we have a forum dedicated to GMP. I'm going to move this post over there, so you can get more specialized help.
Omai
 

tbc
tbc's picture
I attended a training seminar

I attended a training seminar put on by the GMP Institute a few years back. It was very good. They basically train people in GMP's and how to implement GMP programs. Here is their webiste address http://www.gmp1st.com/

Ivan Delgado
Ivan Delgado's picture
I would doing the following

I would doing the following (I was the QA/QC manager at two different companies where I put together GMP/GLP laboratories):
1. Go through the following documents: 21 CFR 210 and 211, GMP standards, and 21 CFR 58, GLP standards. Even though it may be hard to believe, these are the only requirements to satisfy GMP/GLP standards. In my experience GLP standards are more clear than GMP, so when it comes to SOPs and other quality documents you will get more from 21 CFR 58 than 210 and 211, even though both to a great extent overlap in their requirements. Both of these documents are free.
2. The biggest hurdle you will likely face as you get started is where to begin. A good document that will help you with this is the following: ISO 17025:2005. You can buy this standard for about $90. The nice thing about ISO 17025 is that it is an international standard that was written based on GMP/GLP standards.
[Historical perspective: GMP standards were published in 1963 (check this site for some history behind the reasons why the United States had to write GMP standards; it is a good way to gain some perspective behind the reason these standards exist). GLP standards came a little later (made effective in 1979) and their main intent was to support GMP standards, but since then have become their own standards (regulating non-clinical labs; clinical labs are regulated by, you guessed it, GCP standards and CLIA). ISO 17025 came later still (in 2000) and was written based on all that we had learned from GLP and GMP standards]
3. A good place to start is: write an SOP on how to write SOPs. This will define the contents of all your documents. Format and content is key (21 CFR 58 describes this). Along with this document you will need to put together a QA manual. That is where the ISO 17025 document comes in handy: you can use it as a guide as to the contents of your QA manual (along with the 21 CFR 58, 210, and 211). Once you start getting familiar with these three documents you will realize how much overlap there is, and that will help you get a better idea about how to fulfill each requirement.
GMP standards are to a great extent a matter of interpretation. Unfortunately a lot of it has to do with experience (when you get audited you will find out what you have and what you are missing; there is no way around that), so all you can do is put the best system you can and then be ready to work on it when an auditor finds that you are missing something. In rare cases you can argue with an auditor that asks you for something that is not truly required. But I strongly recommend not doing that until you have at least a couple of years, and a dozen or more audits, under your belt as a GxP laboratory .
If you have any questions or need additional help feel free to contact me.

GMP Docs
GMP Docs's picture
Ivan and Omai present good

Ivan and Omai present good suggestions.  I would also recommend checking out the website www.GMPDocs.com.  They have a library of cGMP documents for sale, specifically a few SOPs on how to write SOPs/procedures and document change control!
Check the out:  www.GMPDocs.com
Good luck,
Dan

Radel
Radel's picture
Thank you all for the answers

Thank you all for the answers.
First of all, I have to say that I am from EU (Romania, more precisely) and in Europe are a little bit diffrent rules of GMP than FDA rules. I was developed a quality system based on ISO 9001 but we have some external audits. The auditors told us that a quality system based on ISO 9001 is not acceptable for GMP. Indeed we had only ISO, nothing about GMP. They told us to make (among others) the following procedures:
Risk management (I don't know what to write. I guess I should write about the control of unconform product, acc to ISO?)
Personell hygene
Change control
Qualification
Validation (I have to make a VMP, but how)
Recall
Training
Maintenance
Any advices would be helpful.
Keep intouch.
 

Shubhangi
Shubhangi's picture
Hi basically you have to

Hi basically you have to create lot of changes in your work environment , and documentaion system. As far i see you have no option other than hiring a consultant to learn the things or attend trainings, conferences. Another option is get some idea from experienced collegues.
also you can not start all things at a time. learn one by one.
read relavent guidelines from the web sites . www.fda.gov and www.emea.europa.eu
the rules are not significantly differnet for both. but yes as you stated they are not the same.
its a big task . so good luck