Evidence of Formal Written Procedures

The purpose is to provide the index of critical SOPs submitted to FDA as a part of ANDA and NDA submissions. 

It is the responsibility of all concerned officers and the manager to follow the procedure. The quality assurance (QA) manager is responsible for SOP compliance. 

The evidence of formal written procedures is one of the requirements of cGMP as well as the SOP stated in the Abbreviated New Drug Application (ANDA) and (NDA) New Drug Application to ensure compliance to cGMP requirements. 

The following index identifies the company s key standard operating procedure (SOP) particularly applicable to the ANDA file submitted. Individual companies shall identify their own critical procedures and list them accordingly. 

---