The World Health Organization defines the GMP as follows; GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
The WHO’s definition is simple and clear; prevention is key. We cannot test every tablet, vial or capsule that is distributed to patients worldwide. To make sure that companies understand the GMP’s and it’s requirements there are numerous documents (guidances). Most major economic blocks have their own GMP; the EU has it’s EudraLex and the U.S. has the FDA Code of Federal Regulations. The World Health Organization (WHO) publishes it’s GMP regulations in a set of documents called “Technical Report Series”.
All these documents stress that you must take GMP into account from the very start, whatever you are doing:
Reading through the GMP documents you may lose the overall picture. What do I need to do to prevent errors that cannot be eliminated through QC of the finished product? This is why we have compiled the ten golden rules of GMP. These golden rules are contained in our GMP Basics course in a handout to trainees.
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