According to PIC’s latest guideline on Site master file (PE 008-4). Finished product release shall be controlled through parametric release or process analytical technology. APIC published one guideline for parametric release, which is iam enclosing with this tread. APIC describe the parametric release with statistical approach and risk management technology. Is this mandatory to implement to manufacturing process? Could any body simplify this tool and guide us to implement this technology in easy way.
Comments on this tread is highly appreciated.
Parametric release apic guideline.pdf (112.4 KB)