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.

romankazi
romankazi's picture
Hi Radel,

Hi Radel,
The code of GMP applies to every GMP manufacturing company regardless to Prescription, OTC or Animal health industry. I guess you need guidence instruction SOPs in the area of Quality assurance release for sale criteria, process control, GLP laboratory guidence, validation and revalidation, warehousing and safety etc. You can search those your own country specific regulations or code of GMP for the products you market lacally and for those products you market in overseas you have to comply regulations for those contries.
Anyway I can suggest you to look into a site http://www.gmpqualityup.com
They have good list of SOPs in GMP areas and allowed members to seek guidence online.
Best wishes.  

Ivan Delgado
Ivan Delgado's picture
 

 
Hi Radel,
The short answer to your question is that you need an SOP for every procedure that is critical in your operation. Only you can determine which those SOPs are since you need to go, step by step, through your operation and make sure that every step is documented. It is as simple as that. Two sources that are good at thinking about these requirements (for GMP) are 21 CFR 210 and 211, and ISO 17025.