Documentation in pharmaceuticals manufacturing is very important part so as to give quality assurance of manufactured pharmaceutical product , here i am limiting my writing only to Injectable preparations we will see what are the important requirements for injectable preparations documentation.
We pharmacists have complex responsibilities of ethical, legal, and economical of a pharmaceuticals product manufactured .Hence a documentation of each and every step right from purchase of raw material to dispatch of finished product , helps use to build a standard and perfect and accurate steps by keeping control over each process being done in manufacturing of pharmaceuticals product.
Documentation makes a particular chain of system to control every step ,it defines a system of control.It is required that quality assurance department with production department should establish a system where there are checke points to ensure that all steps in manufacturing of pharmaceuticals right from purchasing of raw material till the dispatch of finished goods are monitored and the comply with the standards.
Documentations should allow for cross referencing so as to trace any step , any material .
I have given in detail all sort of quality assurance documents over this blog , including , validation of finished product , validation of water for pharmaceutical preparation , master manufacturing record , change control format, and SOPS over this blog .