Current Good Manufacturing Practices (cGMP) is a system for ensuring that products (drugs, biologics, etc.) are consistently produced and controlled according to applicable quality standards. cGMP minimizes the risks involved in any manufacturing operation. The most critical aspect of cGMP compliance is the facility where manufacturing operations are conducted. There are 5 aspects of facility operations that need to be validated prior to a facility be suitable for manufacturing FDA-regulated products. The validation of a manufacturing facility requires a thorough understanding of not just the regulations and Guidance Documents, but also the scientific processes, practical and logistical realities, and common-sense measures needed to assure acceptable control of the product from raw material sourcing all the way to the release of the finished products. One-size-fit-all approaches generally lead to an overkill or unacceptable conditions.  

​Why you should attend?

This seminar will highlight the rules and best practices for GMP compliant facility design, construction, validation, operations, and maintenance. Consideration for floor maps, equipment procurement and placement, quality systems (manual and automated), maintenance, access control, containment practices, sanitation, cleaning, waste management, warehousing, and several other critical aspects will be listed at a high-level.

The design, construction, and certification of pharmaceutical facilities play a vital role in mitigating product quality and safety risks. FDA GMP requirements are critical for pharmaceutical companies to understand and apply to build new facilities and rebuild existing ones to be compliant. Facility credentials, and verification establish and provide documented evidence that the site is suitable for use intended for production, testing, compliance with GMP requirements. The presenter would discuss regulatory requirements and best practices using examples and case studies from his vast experience validating and certifying cGMP facilities worldwide. 

Areas Covered in the Session:

• Best practices for floor maps and process flow
• Location of equipment
• Best practices for construction and materials for cGMP facilities
• Manufacturing Layout
• Clean rooms, air, water and electrical systems
• Warehousing Practices
• Security and Access Control
• Sanitation and Cleaning of the Facility
• Waste Management and environmental controls
• Quality systems for operational controls

Who will benefit:

• Manufacturing and Packaging personnel
• Quality Control and Quality Assurance
• Operations Managers
• Regulatory Affairs personnel
• Managers, CEOs & Directors
• Anyone investing in drug and biotech product manufacturing.