Quality Management System

Development of Policies and SOP's for Organisational Structure & Responsibilities, Vendor Management, Material Management, Maintenance & Preventive Maintenance, Recall, Market Complaint, Change Control, Deviation, CAPA, Documentation Control etc.in relation with,

Pharmaceutical Development

• Drug substance development
• Formulation development (including container/closure system)
• Manufacture of investigational products
• Delivery system development (where relevant)
• Manufacturing process development and scale-up
• Analytical method development

Technology Transfer

• New product transfers during development through manufacturing
• Transfers within or between manufacturing and testing sites for marketed products

Commercial Manufacturing

• Acquisition and control of materials
• Provision of facilities, utilities, and equipment
• Production (including packaging and labeling)
• Quality control and assurance
• Release
• Storage
• Distribution (excluding wholesaler activities)

Product Discontinuation

• Retention of documentation
• Sample retention
• Continued product assessment and reporting