Good manufacturing practices in Active Pharmaceutical Ingredients development
“GMP in R&D Working Group” members of the APIC (CEFIC) Principles basic to the formulation of this guideline are:· Development should ensure that all products meet the requirements for quality and puritywhich they purport or are represented to possess and that the safety of any subject in clinicaltrials will be guaranteed.· During Development all information directly leading to statements on quality of criticalintermediates and APIs must be retrievable and/or reconstructable.For more information Click Here