Requirements as per regulatory norms for different markets

OOS investigation policy

Working standard qualification process

Design of specification

Reduced testing program and relevant requirements

API and Excipient reduced testing program

Finish product skip testing program

Stability testing program as per requirement of different markets

In-process testing plan and requirements

Complaint handling

Deviation handling

CAPA management process

Cleaning validation approach

Glassware washing process validation

Risk Assessment

Various improvement activities with cost saving and quality improvement benefits

Control Sample Management

Data integrity policy and requirement

Analytical method validation and verification

Cleaning Method Validation

In-house calibration and PM plan and procedures

Requirements of new lab set up