We provide consultancy services on cGMP compliance to a pharmaceutical organization. Our expert team will review and upgrade the Quality Management Systems with respect to current Good Manufacturing Practices and Regulatory Requirements.

Our approach :

 

• To perform GAP analysis to identify the weaknesses of the systems
• To make a master plan to plug the identified gaps
• To review and upgrade the Quality Management Systems
• To train and increase the competency levels of employees
• To review and compare the improvements at stipulated timelines and update the Management
• Implementation of ICH Q8, ICH Q9 and ICH Q10
• Qualification and validation of facility, equipment, HVAC and water system
• To establish Quality Management System
• Training on GMP / GLP / GCP